Please go to the registration desk and state your last name to be provided your badge. Don't forget to collect your delegate bag on the way in too!

Lunch will be served in the exhibition floor at the catering stations as indicated on the floorplan. Tables and seating can be found throughout the exhibition hall. 

Speakers will include:

Carlos Langezaal FTOPRA  Senior Director Regulatory Affairs, Premier Consulting, United States of America		Carlos Langezaal is Senior Director of Regulatory Affairs for Premier Consulting, a firm that provides strategic solutions and service to emerging biopharmaceutical companies from concept to commercialisation. With 30 years’ experience in regulatory affairs, Carlos has amassed a wealth of experience across all stages of global pharmaceutical development, from pre-investigational new drug application (IND) through to phase III registrational stages. He has been a member of TOPRA’s Symposium Working Party for many years, to which he has applied his knowledge and experience in regulatory strategy.
Paula Loekemeijer Executive Director, Medicines Evaluation Board (MEB), the Netherlands		Paula obtained a pharmacy degree at the University of Leiden and graduated as a Pharmacist at the University of Utrecht. She started  her career at the MEB as a scientific assessor, and held various positions within the Health Inspectorate and the Ministry of Health.   Later on Paula fulfilled several management positions at executive level within the Ministries of Health, Finance and Social Affairs, as well at the General Intelligence and Security Service.  In May 2021 Paula was appointed as Executive Director/General Secretary at the MEB.

With ever evolving technology and science, we have to be at the pulse of innovation and ready to engage, to understand, guide, support, evaluate and communicate.

How do we ensure Regulatory Excellence throughout the system and across stakeholders?

What would one look for in a regulator today and in future?

Come with your thoughts, experience and join the debate with representatives from the European Medicines Agency, Dutch Medicines Evaluation Board, Heads of Medicines Agencies, Industry and patient representatives.

Session Leaders:

Sabine Haubenreisser Principal Scientific Administrator European Medicines Agency		Dr Sabine Haubenreisser is a pharmacologist with a special interest in regulatory and scientific cooperation and convergence to the benefit of public health, through engagement with external stakeholders, the European network of experts and international partners and regulators.   She has held various positions at the European Medicines Agency, in the scientific divisions, international affairs and (currently) stakeholders & communication. She served five years as EMA Liaison Official at the US FDA, where she strengthened cooperation between the European Regulatory Network and the FDA.    Sabine Haubenreisser holds a Master in Pharmaceutical Science from the Johann Wolfgang Goethe-Universität in Frankfurt am Main, a Ph.D. in Pharmacology from the Pharmakologisches Institut für Naturwissenschaftler in Frankfurt am Main, and a certificate in Epidemiology from the London School of Hygiene and Tropical Medicine.
Roelie Marinus Senior Policy Advisor Medicines Evaluation Board (MEB), the Netherlands		Roelie Marinus has a background in healthcare organisation, having earned a Bachelor’s degree in business administration and management before qualifying in nursing. She then began her career managing various nursing wards and healthcare projects. She joined Sanofi in 2013, where she held several patient care management and advocacy roles before becoming Regulatory Science and Policy Associate Director for the EU/AMEE region. In this role, she was responsible for developing, implementing and executing on advocacy policies with the aim of shaping the future regulatory environment to fit company priorities. She currently works as Senior Policy Advisor for the Medicines Evaluation Board in the Netherlands.

Speakers will include:

Emer Cooke Executive Director, EMA, the Netherlands		Emer Cooke is Executive Director of the European Medicines Agency (EMA) and Chair of the International Coalition of Medicines Regulatory Authorities. Starting her mandate as executive director in June 2020 amid a public health crisis of unprecedented scale she announced, “My number one priority will be to drive forward EMA’s response to the pandemic and the work already ongoing to support the development and approval of safe and effective COVID-19 vaccines and treatments.” Doing precisely that has since earned her various accolades including an Honorary Doctorate for outstanding contribution to healthcare (RCSI - 2023).
Hugues Malonne Chief Executive Officer, AFMPS - FAGG, Belgium		Hugues Malonne is Chief Executive Officer of the Federal Agency for Medicines and Health Products (FAMHP). Hugues Malonne obtained his PhD in Pharmaceutical Sciences in 1999. He then earned a Certificate at Harvard Medical School and INSEAD in Paris, and an Executive Master in Management of Health and Care Institutions at the University of Brussels (ULB). He started his career in academia as a Professor before moving on to the pharmaceutical industry. After a successful international career (in Italy, Luxembourg, Switzerland, China, etc.), he returned to Belgium. With his expertise in market access, government affairs, public relations, public policy and pharmaceuticals, Hugues Malonne joined the FAMHP in 2017 as Director General. He successively headed the PRE and POST authorisation departments. As of September 2023, he is the Chief Executive Officer of the FAMHP. Hugues Malonne has a particular interest in addressing drug shortages and exploring innovative therapies, including Advanced Therapy Medicinal Products (ATMP) and vaccines. He is also a member of the Steering Board of CMA (Critical Medicines Alliance). Throughout his career, he has maintained close links with the academic world and continues to teach at ULB and UNamur.
Virginia Acha Associate Vice President – Global Regulatory Policy, EFPIA, Belgium		Virginia (Ginny) has worked in industry and academia throughout her career, combining interests in science policy research and innovation performance within and across organizations.  She joined MSD in 2017 to lead regulatory policy efforts for innovation that will lead to better treatment for patients globally.  Before joining MSD, Ginny was the senior spokesman for the industry in the UK for research, medical and innovation policy (including BREXIT).  Previously, Ginny worked for Amgen in global regulatory policy and for Pfizer working on policy development in science and innovation in healthcare.
Anca Toma Executive Director, European Patients’ Forum, Belgium		Anca Toma joined EPF as Executive Director in March 2022. Her career started in the Romanian EU accession negotiations team, continued as a consultant in a public affairs and communications agency in Brussels, followed by ten years in Smoke Free Partnership, a European coalition of NGOs working to advance tobacco control for cancer and NCD prevention. Anca has over 15 years of experience in European health policy working in policy advocacy, strategic communications, developing and coordinating successful pan-European advocacy campaigns, and leading her team and organisation. Anca is a political science graduate of the University of Bucharest and holds a masters in European politics and administration from the College of Europe.
Aimad Torqui Head of Division: European Cooperation and Veterinary Affairs Division, Medicines Evaluation Board (MEB), the Netherlands		Aimad Torqui has been the Division Head at the Medicines Evaluation Board since September 2022. His role encompasses overseeing (national)policy and European affairs, regulatory science, representation in EU committees, promoting the better use of medicines and veterinary medicines.

 

Catering
Please visit one of the catering stands as indicated on the floorplan to enjoy a cup of coffee or tea during the networking break. Various snacks will also be served during the break. Tables and seating can be found throughout the exhibition floor.

Exhibitors
Don't forget to visit our wonderful exhibitors located throughout the exhibition floor during the break.

Networking
Catch up with old colleagues and make new connections during the break. 

Poster Display
On the exhibition floor, TOPRA are delighted to present a collection of scientific posters submitted by our members – be sure to check them out during the session breaks!

TOPRA Membership Lounge
If you are interested in learning about the opportunities TOPRA offers or just fancy a chat, please be sure to come visit the TOPRA membership lounge located near the entrance to the exhibition.

There are sofas and coffee tables to network at, and the TOPRA stand personnel will be more than happy to answer any queries you may have. There are also plenty of flyers and brochures to pick-up!

This is also where delegates can come and collect their souvenir TOPRA teddy bear and members can collect their TOPRA water bottle.

In recent years, we have witnessed a growing complexity in the clinical research environment and increasing fragmentation across Europe's clinical trials landscape, despite the implementation of the Clinical Trials Regulation (CTR).

Complex and inconsistent requirements across Europe, unnecessary red tape, and a slow uptake of novel approaches are widening the gap between Europe and other regions while hindering innovation.

In this session, we will bring together representatives from regulators, ethics committees, industry, and patient organisations to reflect on the current situation and identify areas where action is needed the most, to re-establish an attractive and highly competitive European clinical research ecosystem; one that supports faster, smarter, and more patient-centric trials.

Session Leaders:

Susan Bhatti MTOPRA Director EU Global Regulatory and Scientific Policy, Merck BV, The Netherlands		Susan Bhatti has been working in pharmaceutical and clinical research industries for more than 25 years. She is Director of Global Regulatory and Scientific Policy at Merck BV where she supports the development of regulatory and scientific policies in Europe. She chairs the Clinical Research Expert Group at the European Federation of Pharmaceutical Industries and Associations (EFPIA) as well as a co-chairing a subgroup focused on patient engagement. She is currently co-leading the multi-stakeholder initiative on cross-border access to clinical trials in Europe (EU-X-CT), which is a joint undertaking by the European Forum for Good Clinical Practice (EFGCP) and EFPIA.
Ana Zanoletty Head of Clinical Trials Transformation, EMA, The Netherlands		Ana Zanoletty is Head of the Clinical Trials Transformation Workstream at the European Medicines Agency (EMA). She is also Programme Manager for Accelerating Clinical Trials in the EU, the European clinical trials transformation initiative. She has a Diploma in Dietetics and Human Nutrition, followed by a BSc in Pharmacy. She worked in clinical research for several years before joining the EMA in 2006 where she spent her initial years coordinating marketing authorisation procedures. She later transitioned into management of post-authorisation procedures.

Speakers will include:

Lada Leyens MTOPRA Senior Director - Regulatory, Takeda, Switzerland		Lada Leyens has a background in human genetics, health economics and personalised medicine. She has worked at Health Authorities for over 8 years, mainly in the approval of clinical trials and as a GCP inspector at Swissmedic. At EMA she was in the specialised disciplines office working in the centralised procedure and with the PKWP and PGWP. At Roche, Lada was the Regulatory Lead for digital health programs and the Regulatory Shaping Lead on Clinical Trial Innovation. At Takeda, she leads the GI and Inflammation regulatory team for the EUCAN region and is vice-chair of EFPIA-CREG. Lada is passionate about leveraging innovative technologies to make drug development more efficient and bringing innovative drugs faster to patients.
Kit Roes Professor of Biostatistics, Radboud University Medical Centre, the Netherlands		Kit Roes is Professor of Biostatistics at Radboud University Medical Center Nijmegen (Netherlands). He is chair of the Methodology Working Party of the European Medicines Agency, and senior expert at the Dutch Medicines Evaluation Board. His research focus is design and analysis of clinical trials in the context of regulatory science, with an emphasis on innovative designs, rare diseases and bridging the gap between clinical trials and real world evidence. He serves on multiple Data and Safety Monitoring Boards. His experience includes over 25 years in clinical research in the pharmaceutical industry and academic life sciences, serving clinical research and drug development as expert as well as in different (international) senior management positions.
Marén U. Koban Director, Global Regulatory and Scientific Policy, Merck Healthcare KGaA, Germany		Marén Koban is Director of Global Regulatory and Scientific Policy at Merck Healthcare KGaA, Darmstadt. She currently focuses on policy work around real-world data and evidence, clinical trial modernisation and digital health. She has more than 15 years of experience across biologicals and small molecules gained at various global pharmaceutical enterprises. Marén holds a PhD in Molecular Biology from Imperial College London, a Master’s degree in Drug Regulatory Affairs from Bonn University and a German Diploma in Chemistry.
Katarina Nedog Associate Director, Drug development and Manufacturing, European Federation of Pharmaceutical Industries and Associations (EFPIA), Belgium		Katarina Nedog is the Associate Director of Science Policy & Regulatory Affairs at the European Federation of Pharmaceutical Industries and Associations (EFPIA), representing Europe's R&D-based pharmaceutical industry. Since taking on this role in September 2023, she has focused on key areas such as regulatory affairs and drug development, with expertise in clinical trials, preclinical development and pharmacovigilance. Her work involves engaging with external stakeholders and shaping regulatory frameworks that promote innovation and patient safety. With over 15 years of experience in the pharmaceutical industry and trade associations, Katarina previously worked as a Regulatory Affairs & Policy Consultant, advising companies on regulatory compliance and process optimisation. From 2018 to 2022, she led a global team as Head of Business Process Excellence at Sandoz, overseeing regulatory document delivery and driving digital transformation. She has also held key roles at Medicines for Europe and Lek Pharmaceuticals, developing expertise in policy, stakeholder engagement and regulatory strategy. A Slovenian national, Katarina holds a Master’s degree in Pharmacy from the University of Ljubljana and has further enhanced her skills through various courses in leadership, project management, and communication.

Panellists will include:

Begonya Nafria Escalera Patient Engagement Research Coordinator, Hospital Sant Joan de Déu, Spain

Begonya Nafria has long experience in the field of patient and family participation in research initiatives. Her personal history as a caregiver for an adult with cerebral palsy has linked her to various projects and initiatives in the field of defending patients' rights. Her areas of expertise focus on the participation of paediatric patients in research and specifically in the field of clinical trials. Relevant aspects of hes curriculum are: CIBERER collaborator, EUPATI member, eYPAGnet Coordinator, Kids Barcelona Coordinator (YPAG of Hospital Sant Joan de Déu), member of the EFGCP Children's Medicines working group and member of the working group of patients and families of EnprEMA (European Network for Pediatric Research of EMA). She is also a reviewer for various journals specialized in the subject of patient participation in research and rare diseases, and a teacher in seminars, courses and conferences.

Catering
Please visit one of the catering stands as indicated on the floorplan to enjoy a cup of coffee or tea during the networking break. Various snacks will also be served during the break. Tables and seating can be found throughout the exhibition floor.

Exhibitors
Don't forget to visit our wonderful exhibitors located throughout the exhibition floor during the break.

Networking
Catch up with old colleagues and make new connections during the break. 

Poster Display
On the exhibition floor, TOPRA are delighted to present a collection of scientific posters submitted by our members – be sure to check them out during the session breaks!

TOPRA Membership Lounge
If you are interested in learning about the opportunities TOPRA offers or just fancy a chat, please be sure to come visit the TOPRA membership lounge located near the entrance to the exhibition.

There are sofas and coffee tables to network at, and the TOPRA stand personnel will be more than happy to answer any queries you may have. There are also plenty of flyers and brochures to pick-up!

This is also where delegates can come and collect their souvenir TOPRA teddy bear and members can collect their TOPRA water bottle.

Until a few years ago the trending hashtags were blockchain, real world evidence, and accelerated pathways. Soon after, Parallel advice and Health Technology Assesment Bodies, and Payors came to the fore, suddenly out of nowhere the world was hit with Generative AI. 

Let’s face it: the healthcare industry never had issues keeping up with the times and health agencies are no different. The European Medicines Agency (EMA) and U.S Food and Drug Administration (FDA) issued guidance relating to the use of AI in 2023. This year both Agencies and the EU regulatory network have also started implementing generative AI in-house. 

This session aims to shed light on the Agencies’ approach to balancing the need for swift access to groundbreaking treatments with the imperative of ensuring public safety. By fostering an open exchange of ideas, the chat will provide insights into the EMA’s, the European Regulatory network and FDA's current initiatives, their future directions, and the broader implications for public health policy and practice.

Join us for a compelling conversation that promises to deepen our understanding of the complexities at the intersection of healthcare innovation and regulation, and to envision the future of public health in a rapidly evolving landscape.

Session Leaders:

Sabine Haubenreisser Principal Scientific Administrator, European Medicines Agency		Dr Sabine Haubenreisser is a pharmacologist with a special interest in regulatory and scientific cooperation and convergence to the benefit of public health, through engagement with external stakeholders, the European network of experts and international partners and regulators.   She has held various positions at the European Medicines Agency, in the scientific divisions, international affairs and (currently) stakeholders & communication. She served five years as EMA Liaison Official at the US FDA, where she strengthened cooperation between the European Regulatory Network and the FDA.    Sabine Haubenreisser holds a Master in Pharmaceutical Science from the Johann Wolfgang Goethe-Universität in Frankfurt am Main, a Ph.D. in Pharmacology from the Pharmakologisches Institut für Naturwissenschaftler in Frankfurt am Main, and a certificate in Epidemiology from the London School of Hygiene and Tropical Medicine.
Francesca Buttigieg MTOPRA Regulatory Affairs Professional, Switzerland		Francesca has volunteered with TOPRA since 2013 in a number of CRED courses and in organising the annual Symposium. She subsequently took on the role of Chair of the working party for the Human Medicines Symposium. She holds an undergraduate degree in pharmacy and an MSc in regulatory affairs. She entered into regulatory affairs in 2008 with various roles in the generics field. She then moved to the novel pharma space in 2013. Since then, she has been responsible for gaining regulatory approvals, supporting and maintaining marketing authorisations for various oncology products in Europe, Middle East and Africa.

Speakers will include:

Anthonius de Boer Chairman of Medicines Evaluation (MEB), the Netherlands		Emeritus Prof. Anthonius de Boer, MD, PhD was trained for three years in Internal Medicine followed by a PhD research period in clinical pharmacology. After his PhD graduation in 1990 he was appointed as assistant professor in Clinical Epidemiology followed by an associate professorship of pharmacotherapy. In 1994 he was registered as Epidemiologist and in 1996 as Clinical Pharmacologist. He was appointed in 2001 as professor of pharmacotherapy and director of the Pharmacy School. From 2007 until September 2015 he was the head of the Department of Pharmaceutical Sciences, Utrecht University. From the first of August 2017 he is also the chair of the Netherlands Medicines Evaluation Board. On 22 June 2022 he retired and became Emeritus Professor.
Peter Marks Director, FDA, United States of America		Peter Marks holds a degree in Cell and Molecular Biology, and a medical degree, both from New York University. He also completed an internal medicine residency, and hematology and medical oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching and caring for patients and in industry on drug development and is an author or co-author of over 125 publications. He joined the FDA in 2012 and currently serves as Director for its Center for Biologics Evaluation and Research (CBER).
Steffen Thirstrup Chief Medical Officer, European Medicines Agency, the Netherlands		Steffen Thirstrup is a medical doctor and board-certified specialist in clinical pharmacology and therapeutics. He holds a PhD in Pharmacology and has an extensive background in clinical internal medicine with special emphasis on adult respiratory medicine. Additionally, he was appointed Adjunct Professor in pharmacotherapy at the Faculty of Health Sciences, University of Copenhagen, in 2012. From 2004-09, he worked at the Danish Medicines Agency first as the Danish member of CHMP at the European Medicines Agency (EMA) for five years, followed by a short period as Head of the Danish Institute for Rational Pharmacotherapy. In 2011, he rejoined the licensing division at the Danish Medicines Agency acting as Head of Division for Medicines Assessment and Clinical Trials. In April 2014, he was appointed as Director for the Regulatory Advisory Board at NDA Regulatory Services Ltd., having joined as a medical advisor in 2013. He has been Chief Medical Officer at the EMA since June 2022.

 

Electronic Product Information (ePI) holds critical medicinal product information available to patients and healthcare providers almost in real time. Discover current state and factors needed for EU implementation and the overview of the EMA/HMA ePI Pilot Project.

Electronic Product Information (ePI) represents a standardized approach expanding public access to precise, real-time information regarding summary of product characteristics, labeling, and package leaflets. Notably, ePI incorporates technical features that facilitates the use of common data standards and structured content exchanged using FHIR technology, which enables seamless interoperability across the healthcare ecosystem. The EU member states adopted a common ePI standard and other countries globally have followed the same pathway. While a great first step, an opportunity to fundamentally transform how industry communicates product information to patients and healthcare providers remains.

ePI brings significant benefits as it allows patients with timely and accurate insights into their prescribed therapies. Patients gain access to the most current prescribing guidelines such as dosage, adverse reactions, and safety updates. Healthcare professionals (physicians and pharmacists) benefit by using structured content in ePI to support clinical decisions on treatments. ePI could also be integrated with electronic health records and e-prescribing systems, creating a seamless workflow for healthcare professionals, delivering a level of personalized medicine by highlighting the most effective therapy for patients with a specific diagnosis or clinical profile.

Recognizing the need for industry-wide coordination to make this paradigm shift a reality, this session will bring together a panel of leading voices in the ePI space. The session will deep dive into a range of topics and recommendations including the role of international data standards and exchange mechanisms for interoperability; impact of requirements on authoring structured content; strategies to overcome multilingual barriers in regulatory review; benefits of ePI in the mitigation of shortages; modernize legacy/emerging systems to allow for ePI processes; safeguarding personal identifiable information in patient-centric third-party applications.

Session Leaders:

Carlos Langezaal FTOPRA  Senior Director Regulatory Affairs, Premier Consulting, United States of America		Carlos Langezaal is Senior Director of Regulatory Affairs for Premier Consulting, a firm that provides strategic solutions and service to emerging biopharmaceutical companies from concept to commercialisation. With 30 years’ experience in regulatory affairs, Carlos has amassed a wealth of experience across all stages of global pharmaceutical development, from pre-investigational new drug application (IND) through to phase III registrational stages. He has been a member of TOPRA’s Symposium Working Party for many years, to which he has applied his knowledge and experience in regulatory strategy.
Katja Pečjak Reven MTOPRA EU/UK QPPV, Billev Pharma East Ltd., Slovenia		Katja has a Master’s in Pharmacy and has been working in the pharmaceutical industry for 20 years. Her journey in Billev Pharma East Ltd. started in September 2008 as a Director of Regulatory Affairs and EU Qualified Person Responsible for Pharmacovigilance (QPPV).  Her expertise has been sought when she was called upon to assume the role of Subject Matter Expert in the European Medicines Agency’s (EMA) electronic patient information (ePI) pilot project  EMA ePI Pilot Project, representing the Pharmaceutical Industry perspective since July 2022. She is a member of Medicines for Europe working groups (RSAC, Telematics), TOPRA and an ePI Topic Group Lead in IRISS Forum.

Speakers will include:

Elizabeth Scanlan Scientific Communication Officer & ePI Product Owner, EMA, the Netherlands		Elizabeth Scanlan is Product Owner for electronic product information (ePI) at the European Medicines Agency. Prior to joining EMA in 2016, she worked in communication roles in the biotechnology industry and not-for-profit sector. She holds a PhD in molecular biology from Trinity College Dublin.
Jasper-Hugo Brouwers Head of Corporate & Stakeholder Affairs, MEB, the Netherlands		Jasper-Hugo Brouwers has a background in media management and in people management. He graduated with a BBA in Media & Entertainment Management from the Christian University of the Netherlands in 2006 and has since achieved a Bachelor of Commerce from Stenden University. Between 2008 and 2014 he worked as a media and PR consultant with various firms including UMC Utrecht, before joining the Medicines Evaluation Board as acting Head of Communications. Over the past ten years, Jasper has been promoted five times, ultimately to his current position as Head of Corporate & Stakeholder Affairs.

Catering
Please visit one of the catering stands as indicated on the floorplan to enjoy a cup of coffee or tea during the networking break. Various snacks will also be served during the break. Tables and seating can be found throughout the exhibition floor.

Exhibitors
Don't forget to visit our wonderful exhibitors located throughout the exhibition floor during the break.

Networking
Catch up with old colleagues and make new connections during the break.
 
Poster Display
On the exhibition floor, TOPRA are delighted to present a collection of scientific posters submitted by our members – be sure to check them out during the session breaks!

TOPRA Membership Lounge
If you are interested in learning about the opportunities TOPRA offers or just fancy a chat, please be sure to come visit the TOPRA membership lounge located near the entrance to the exhibition.

There are sofas and coffee tables to network at, and the TOPRA stand personnel will be more than happy to answer any queries you may have. There are also plenty of flyers and brochures to pick-up!

This is also where delegates can come and collect their souvenir TOPRA teddy bear and members can collect their TOPRA water bottle.

The understanding and practice of global health is shifting significantly. For too long global health has been understood to be a one-way street from the developed to the developing countries in terms of money, priorities and solutions. While early definitions had stressed the impact of global interdependence on the determinants of health and the transfer of health risks from the Global North to the Global South, it was COVID19 that has acted as an amplifier in demonstrating the lack of global solidarity in addressing a global health crisis as well as illustrating the shortcomings of established approaches. One challenge lies in the very reduced appetite of countries to agree to global rules.

At present two test cases are driving the agenda: the negotiations of a pandemic accord at the World Health organization and the response to the mpox Public Health Emergency of International Concern (PHEIC). Equity has been moved forcefully into the center of the global health arena in a very practical and political way – an obvious example is the demand to establish a system of access and benefit sharing by the negotiators from the Global South.

Global health equity is now about:

•  Global supply chains, access and participation in the global health industry, production sites, data sovereignty, establishment of research centers, supporting locally driven innovations, developing digital and AI solutions;
•  Establishing sovereign health systems, policies and programs, an agenda closely linked to economic development agendas – such as the Bridgetown Initiative;
•  Addressing the challenges of climate change and the many ways they are linked to health;
•  Highlighting the health toll of the commercial determinants of health, as reflected in high levels of non-communicable diseases.

Regional agendas, organizations and coordinated efforts from the Global South, such as the African Global Health Initiative are beginning to take on a leadership role, the G20 presidencies have also played a strong role in shifting the agenda. The deeply political nature of global health becomes ever clearer as political and economic power shifts.

Speaker:

Professor Ilona Kickbusch Founder and Chair of the Global Health Centre, Graduate Institute of International and Development Studies, Switzerland

Professor Kiekbusch key interests relate to the political determinants of health, health in all policies and global health. She is the founder of the Global Health Centre at the Graduate Institute, Geneva. She advises countries and organizations on their global health strategies and trains health specialists and diplomats in global health diplomacy. She continues to advise the WHO.  She is a member of the Global Preparedness Monitoring Board. She acts as Council Chair to the World Health Summit in Berlin and is vice-president of the European Health Forum Gastein. She has been involved in German G7 and G20 activities relating to global health and the global health initiatives of the German EU presidency in 2020. She chaired the international advisory board for the development of the German global health strategy. She publishes widely and serves on various commissions and boards. She initiated the @wgh300 list of women leaders in global health. She is program chair of the leaders in health network SCIANA. She is co-chair of a Lancet FT Commission on "Governing health futures 2030: growing up in a digital world." She continues to advise the World Health Organization.  Professor Kiekbusch has had a distinguished career with the World Health Organization. She was key instigator of the Ottawa Charter for Health Promotion and WHOs Healthy Cities Network and has remained a leader in this field. She was the director of the Global Health Division at Yale University School of Public Health and responsible for the first major Fulbright Programme on global health. She has published widely and received many prizes and recognitions.  She has been awarded the Cross of the Order of Merit of the Federal Republic of Germany (Bundesverdienstkreuz) in recognition of her "invaluable contributions to innovation in governance for global health and global health diplomacy".

 

All TOPRA members are invited to attend this year’s Annual Review Meeting for the presentation of the previous year’s financial results, the announcement of new Board Directors, and the awards and honours that recognise contributions to our valued TOPRA community.

Speakers will include:

Michael Kipping MTOPRA Director, Medical Technologies EMEAA, Element, United Kingdom		Michael is Director, Medical Technologies EMEAA for Element Materials Testing, which is a global testing, inspection, calibration and certification business. Previously, he worked for Innovate UK as a Health Innovation Lead managing a UK government grant funding programme (Biomedical Catalyst) that provided £30M per annum to support UK SMEs developing innovative health and life science products.
Aman Khera FTOPRA Vice President, Regulatory Science, Strategy and Innovation Worldwide Clinical Trials, Canada		Aman is Vice President, Regulatory Science, Strategy & Innovation at Worldwide Clinical Trials, a global contract research organisation (CRO). Aman provides global strategic direction in regulatory affairs, having led a wide range of regulatory projects providing strategy and development services for a variety of client sponsor companies.

Catering
Please visit one of the catering stands as indicated on the floorplan where lunch will be served. Various snacks will also be served during the break. Tables and seating can be found throughout the exhibition floor.

Exhibitors
Don't forget to visit our wonderful exhibitors located throughout the exhibition floor during the break.

Networking
Catch up with old colleagues and make new connections during the break. 

Poster Display
On the exhibition floor, TOPRA are delighted to present a collection of scientific posters submitted by our members – be sure to check them out during the session breaks!

TOPRA Membership Lounge
If you are interested in learning about the opportunities TOPRA offers or just fancy a chat, please be sure to come visit the TOPRA membership lounge located near the entrance to the exhibition.

There are sofas and coffee tables to network at, and the TOPRA stand personnel will be more than happy to answer any queries you may have. There are also plenty of flyers and brochures to pick-up!

This is also where delegates can come and collect their souvenir TOPRA teddy bear and members can collect their TOPRA water bottle.

 

Speakers will include:

Margareth Jorvid FTOPRA Chief Executive Officer, Methra Uppsala AB, Sweden		Margareth Jorvid is CEO for Regulatory Affairs and Quality Assurance at Methra Uppsala AB. With more than 30 years’ experience in regulatory affairs, she has worked at the Swedish Medical Products Agency (MPA) as well as small and large pharmaceutical and biotechnology companies. Since 2006, she has worked as a consultant in regulatory affairs and quality assurance for pharmaceuticals, advanced therapy medicinal products, medical devices and combination products through Methra Uppsala AB. She holds an MSc Pharm from Uppsala University, an MBA from the Stockholm School of Economics in Sweden, and an MSc MTRA from Cranfield University in the UK.
Karla van Rooijen Director of Medicines and Medical Technology, Medical Technology at Ministry of Health, Welfare and Sport, The Netherlands		Karla has held the position of Managing Director of GMT for the past six months. Prior to that, she was a member of the Management Team of the Human Tissue and Medical Technology clusters and also deputy director of the GMT Directorate. Karla has also been HR Manager at the Ministry of Health, Welfare and Sport. Before joining the Ministry of Health, Welfare and Sport, she held various positions within the Ministry of Economic Affairs and Climate Policy, including in the field of foreign economic relations.

 

This session will look into opportunities and challenges with application procedures and performing a combined clinical trial in Europe, that involves a medicinal product and an in vitro diagnostic (IVD), or companion diagnostic (CDx) and/or a medical device (MD) component. The clinical trial application for the medicinal product is submitted under the Clinical Trial Regulation (CTR) via the Clinical Trials Information System (CTIS), while the device/diagnostic follow different national procedures. An update on the COMBINE project will be included.

13:40 – Introduction
 
13:45 – The COMBINE project, an update and the way forward, Olga Tkachenko  

14:05 - A Competent Authority contribution to the COMBINE project and the MPA approach to combined clinical trials, Elin Karlberg 

14:25 - Industry perspective on opportunities and challenges with Drug/IVD/CDx/MD clinial trials, Vladimir Vujovic 

14:45 – Panel Discussion and Q & A 

Session Lead:

Margareth Jorvid FTOPRA Chief Executive Officer, Methra Uppsala AB, Sweden

Margareth Jorvid is CEO for Regulatory Affairs and Quality Assurance at Methra Uppsala AB. With more than 30 years’ experience in regulatory affairs, she has worked at the Swedish Medical Products Agency (MPA) as well as small and large pharmaceutical and biotechnology companies. Since 2006, she has worked as a consultant in regulatory affairs and quality assurance for pharmaceuticals, advanced therapy medicinal products, medical devices and combination products through Methra Uppsala AB. She holds an MSc Pharm from Uppsala University, an MBA from the Stockholm School of Economics in Sweden, and an MSc MTRA from Cranfield University in the UK.

Speakers will include:

Vladimir Vujovic Director, Clinical Trials Regulatory, IQVIA, Serbia		Vladimir Vujovic, a Master of Pharmacy, has more than a decade of experience in regulatory affairs, primarily focusing on drug and MD/IVD studies regulatory applications and compliance. Vlad has guided the transition of device trials to new EU regulatory frameworks, as well as drug trials under the EU CTR. At IQVIA, where he serves as the Director of Clinical Trials Regulatory, he is a subject matter expert on the IVDR/CTR clinical trials interface, streamlining combined study submissions, and on the MDR/IVDR’s lateral impact on clinical trial conduct under the EU CTR. His dual expertise in medicinal products and medical devices enables a comprehensive approach to combination product development and clinical research. He is currently the ACRO representative within the EC Combine project.
Olga Tkachenko Policy Officer, European Commission, Belgium		Olga Tkachenko graduated with an MSci and BA in Natural Sciences (Biochemistry) from the University of Cambridge in 2013 and went on to obtain a PhD in Physical and Theoretical Chemistry from the University of Oxford, where she investigated mechanisms of protein aggregation in neurodegenerative disease. She joined the medical devices team at the European Commission in December 2017, where she works as a Policy Officer. Her responsibilities include various aspects of in vitro diagnostics, borderline products and collaboration with the Joint Research Centre for establishment of EU reference laboratories. She is chair of the In Vitro Diagnostics sub-group of the Medical Device Coordination Group. The IVD sub-group consists of national competent authorities, with stakeholders participating as observers, and oversees the implementation of Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
Elin Karlberg Head of Regulatory Group, Department of Clinical Trials and Special Permissions, Medical Products Agency/Läkemedelsverket, Sweden		Elin Karlberg was educated in pharmacy and began her career in regulatory affairs as a Clinical Research Associate at Smerud Medical Research. She was later promoted to Country Manager for Sweden and finally to Clinical Research Scientist, in which roles she advised her teams on regulatory issues. In 2015 she started her own company, offering clinical development and regulatory and clinical advice. She joined the Swedish Medical Products Agency in 2015 as a regulatory assessor and was later promoted to group leader. In 2022, Elin was chosen to co-Chair of the Clinical Investigation and Evaluation Group, a subgroup of the Medical Devices Coordination Group at the European Commission. She is a highly regarded regulatory expert in clinical affairs, for both medicines and medical devices, having given a seminar at MedTechLabs and been published twice in Oxford Academic.

Panellists will include:

Silvy Da Rocha Head of Office for Expert Panels and Groups Office, EMA, The Netherlands

Silvy da Rocha Dias joined regulatory affairs from the science side, having achieved her Bachelor’s degree, Master's degree and PhD in immunology. She worked at several prestigious institutions as a researcher in the field of cancer immunology and was published in many journals between 1996 and 2006. She then transitioned into medical writing and joined the European Medicines Agency in 2007, where she spent several years as Scientific Administrator for oncology, haematology and diagnostics and more recently, as Office Head, leading Expert Panels on medical devices.

Catering
Please visit one of the catering stands as indicated on the floorplan to enjoy a cup of coffee or tea during the networking break. Various snacks will also be served during the break. Tables and seating can be found throughout the exhibition floor.

Exhibitors
Don't forget to visit our wonderful exhibitors located throughout the exhibition floor during the break.

Networking
Catch up with old colleagues and make new connections during the break. 

Poster Display
On the exhibition floor, TOPRA are delighted to present a collection of scientific posters submitted by our members – be sure to check them out during the session breaks!

TOPRA Membership Lounge
If you are interested in learning about the opportunities TOPRA offers or just fancy a chat, please be sure to come visit the TOPRA membership lounge located near the entrance to the exhibition.

There are sofas and coffee tables to network at, and the TOPRA stand personnel will be more than happy to answer any queries you may have. There are also plenty of flyers and brochures to pick-up!

This is also where delegates can come and collect their souvenir TOPRA teddy bear and members can collect their TOPRA water bottle.

Artificial Intelligence (AI) and machine learning (ML) tools are increasingly being explored across all areas of the medicinal product lifecycle, from identifying novel targets to supporting healthcare professionals. Societally, we see the beginning of AI legislation being developed globally including the EU’s AI Act and in parallel health authorities are accelerating the development of AI guidance’s and regulatory frameworks.The growth of this digital technology is exponential and digitilisation and AI/ML are touching all parts of the regulatory process. As more and more AI/ML technologies become embedded in our regulatory landscape are we effectively exploring how these tools can also re-shape the work of regulatory professionals both within industry and health authorities? Tools such as large-language models and generative AI offer opportunities to support drafting, compiling, translations and reviewing activities for global medicinal product dossiers.

Recognizing AI's ubiquity in medicinal product life cycles, the European Medicines Agency (EMA) Reflection Paper and AI Roadmap focuses on regulatory impact and risk analysis for AI/ML applications. EMA encourages early engagement, emphasizing standard operating procedures (SOPs) for data and algorithm governance, ensuring compliance with data protection laws and ethical standards. Applicants and Marketing Authorization Holders must ensure personal data in AI/ML models adheres to data protection laws. The EMA, illustrating its commitment to AI, also discusses utilizing these technologies to optimize its processes, acknowledging their transformative potential in healthcare data analysis.

While these new digital tools offer a more efficient way to deliver the status quo we should also explore how these innovations can drive the next generation of regulatory science and regulatory practice. Will use of these AI tools create efficiencies to address resourcing challenges? Or will the use of AI tools actually require greater oversight by regulatory professionals?

In this panel session we will discuss the opportunities, needs and challenges encountered in the shift to an AI/ML embedded environment for medicine regulation. We will discuss the implementation and oversight of these tools within regulatory functions and how their use may change the training needs of the regulatory professionals of the future.

Session Leaders:

Carla Jonker Senior Regulatory Project Leader, MEB, the Netherlands		Carla Jonker combines her position as Senior Regulatory Project Leader at the Medicine Evaluation Board in the Netherlands with her work as National Expert in the Real World Evidence department within the Data Analytics and Methodology Task Force at the European Medicine Agency. She has over 20 years’ experience, both in industry in different positions and at the Medicine Evaluation Board. Her work experience includes multiple topics related to the benefit-risk assessment of medicinal products and a PhD research at the University of Utrecht to investigate the value of rare disease registries for regulatory decision-making.
Rebecca Lumsden MTOPRA Head of Regulatory Science and Policy, EU/AMEE region, Sanofi, United Kingdom		Rebecca joined Sanofi in 2022 to lead its regulatory science and policy efforts in Europe, Africa and the Middle East. She also coordinates specific global projects with a goal of fostering new approaches for early access of medicines for the benefit of patients. Focus areas include expedited regulatory pathways, digital and data transformation. She is actively involved within the European Federation of Pharmaceutical Industries and Associations as Co-Chair of the European Regulatory Affairs and Operations group.

Speakers will include:

Florian Lasch Biostatistics Specialist, EMA, The Netherlands		Florian is a Biostatistician with a degree in mathematics and a PhD from Hannover Medical School. Florian works as a Biostatistics Specialist at the European Medicines Agency, providing scientific support to development and evaluation throughout all stages of marketing authorisation assessments of medicinal products, and leads the ACT EU Priority Action on Clinical Trial Methodologies and co-leads the EMA Health Data Lab.
Karen Philippe Generative Artificial Intelligence Regulatory Lead, Sanofi, France		Karen Philippe is an established regulatory affairs professional with over a decade of experience across major pharmaceutical companies, both at affiliate and global levels. Karen’s expertise spans product registration and maintenance across immunology, oncology, rare diseases and vaccines. Karen has driven numerous cross-functional projects and successful product approvals. Her passion for digital innovations and artificial intelligence (AI) has enabled her to lead initiatives in generative AI dossier content generation, leveraging her extensive experience to transform regulatory affairs. Karen holds a PharmD and a Master’s degree in Regulatory Affairs and Biotechnology from Strasbourg University and is currently serving as the GenAI Regulatory Lead at Sanofi.
Nicolas Perez Gonzalez  Data Scientist, Swissmedic, Switzerland		Dr. Nicolas Perez holds a PhD from Johns Hopkins University on Chemical and Biomolecular Engineering where he developed high throughput imaged based analysis systems for microfluidic technologies. He worked in the University Hospital of Zurich as a Machine Learning Researcher and is now a Data Scientist at Swissmedic, the national authorization and supervisory authority for drugs and medical products in Switzerland where he develops new products for the experts within Swissmedic.
Jay Nanavati Head of Advanced NLP, IQVIA, United Kingdom		Jay Nanavati is a visionary leader on the cutting edge of computational linguistics. He holds a Bachelor’s and a Master’s degree in computer science from UCL and the University of Oxford respectively. He was an early pioneer in healthcare AI, having worked in the field from as early as 2016. Between 2018 to 2020 he led the development of the world’s first clinically adopted machine learning model (project InnerEye) at Microsoft, for which he was published in JAMA. After founding Runcircle, a wellbeing platform, Jay joined AstraZeneca, where he rose to be Director of Graph AI and Natural Language Processing. Since 2023, he has led the Natural Language Processing Research and Development Department at IQVIA, where his team are researching large language models and generative AI.

Clinical evidence generation for healthcare products has advanced to include a range of data sources and methodological approaches. Although clinical trials (CTs) remain the research modality most relied upon by regulatory authorities for establishing clinical safety and efficacy, the lifecycle of evidence generation for medicines and vaccines increasingly embrace a combination of approaches which includes real-world evidence (RWE).
 
Enabling access to innovative new medicines requires a range of approaches to evidence generation over the lifecycle of this product. This session will broaden the conversation on clinical evidence generation beyond traditional silos of clinical trials and real-world evidence generation to consider how we can holistically work in collaboration to generate evidence that meets the needs of decision makers through the product lifecycle.
 
The session will showcase some learnings on regulatory-led studies leveraging the EMA’s 2nd report on RWE, and probe the interface between different European initiatives such as EHDS, the Big Data initiatives (including DARWIN EU) and how these may link into a broader strategic vision for the EU medicines regulatory network.


Session Lead:

Álmath Spooner Head of Europe Regulatory Policy and Intelligence AbbVie, Ireland		Álmath Spooner is Head of Europe, Regulatory Policy and Intelligence at AbbVie. She is a dual qualified pharmacist and barrister and earned her PhD at Trinity College Dublin. At AbbVie, she heads up the Europe regulatory policy team and is global regulatory policy topic lead for patient focused drug development, real-world evidence and pharmacovigilance. At the European Federation of Pharmaceutical Industries and Associations, she is the Chair of the Integrated Evidence Generation and Use Working Group.
Denise Umuhire Pharmacoepidemiology & RWE Specialist, European Medicines Agency (EMA), the Netherlands		Denise Umuhire is a diverse healthcare data professional, having experience in both the private and the regulatory side of the industry. She began her career working in health economics for various consultancy and other professional bodies, rising to the level of Consultant. After her MBA, she worked as a leader in two major healthcare companies (Johnson & Johnson and Roche) before starting her current role as Pharmacoepidemiology and Real-world Evidence Specialistat the European Medicines Agency. Denise has been published in several peer-reviewed journals and is a frequent speaker at industry conferences. She holds a Bachelor's degree in international and industrial economics, an MSc in statistics and an MBA.

Speakers will include:

Alexandra Pacurariu  Senior Epidemiologist, EMA, the Netherlands		Alexandra Pacurariu is an epidemiologist with more than 10 years’ experience in real world studies across different therapeutic areas.   A pharmacist at origin, she has a PhD in pharmacovigilance from Erasmus Medical Center, Rotterdam and a mixed academic, consultancy and a regulatory background gained from working for Dutch Agency and European Medicines Agency.  Her additional experience is in pharmacovigilance, statistics and epidemiological methodology.   Born in Romania, she studied and lived in several countries, including Austria, the Netherlands and UK. Currently based in Amsterdam, working as a senior epidemiologist at the European Medicines Agency.
Gracy Crane Regulatory Policy Lead, Roche, United Kingdom		Gracy Crane is a cancer biologist by training with a Master in Biomedical Research and a Ph.D. in Cancer Biology. She has also completed post-doctoral training fellowships at Oxford University (UK) and Massachusetts Institute of Technology (USA). She has over 12 years of years of experience in the pharmaceutical industry, in varying roles including medical and scientific affairs, clinical development, health outcomes research and real world data. For the past 5 years, she has worked on leading the real world evidence strategy for molecules within the rare cancer space as part of the global Data Science team at Roche. Currently, she is the RWD policy lead within the Global Regulatory Policy team at Roche. She has authored many publications on this topic and has presented in many international conferences. Gracy is also part of a number of external steering/working groups including the ISPOR RWD transparency Initiative, the CIOMs working group on RWD/E guidelines, and the Duke Margolis RWE Collaborative.
Jerome de Barros Policy Officer, European Commission, Belgium		Jerome de Barros is a policymaker at the European Commission (DG SANTE) with 10+ years of experience in Digital Health programmes and policies. He is one of the policy officers responsible for the implementation of the European Health Data Space (EHDS) legislation and IT infrastructures, with a focus on data quality aspects, and secondary uses of data, including research and innovation. Prior to joining the Commission, he was the Data Driven Innovation Lead for Health & Care at the University of Edinburgh working, among other projects, on the set up of the DataLoch, a health data infrastructure bringing together and leveraging health and social care data for the South-East Scotland region.
Claus Møldrup Director of DAC (Data Analytics Center), Lægemiddelstyrelsen/Danish Medicines Agency, Denmark		Claus Møldrup is the Director of the Data Analytic Center at the Danish Medicines Agency and holds a PhD /Post. Doc. in pharmacy. Before his current position, he worked as full professor at the University of Copenhagen in the research field of Social pharmacy. Later he joined Big Pharma as commercial director and founded two health tech companies focusing on RWE in relation to pharmaceutical products.
Elisabeth Kasilingam CEO, European Multiple Sclerosis Platform, Belgium		Elisabeth Kasilingam is currently serving as the Chief Executive Officer of the European Multiple Sclerosis Platform (EMSP) and as Vice-President of the European Patients’ Forum. In these roles, she is highly committed to working towards better quality of life of patients with MS and other chronic conditions by the implementation of successful, results-oriented projects and policy campaigns and actions.  Elisabeth entered the European political arena more than 15 years ago, pursuing her interests in the field of human rights and specialising in the health and social sectors. In her work with EMSP, Elisabeth has been developing capacity-building programmes to support the further development of national MS patient organisations and health and social advocacy campaigns, as well as engagement activities to develop young patient advocates.

Small and medium sized companies (SMEs), Academia and Start-ups meet different regulatory challenges when developing the life science products of the future to meet patients’ needs. This day is to explore regulatory news, to receive an update on recent changes and also to understand the support available and provided to SMEs, Academia and Start-ups.

Session Lead:

Margareth Jorvid FTOPRA Chief Executive Officer, Methra Uppsala AB, Sweden

Margareth Jorvid is CEO for Regulatory Affairs and Quality Assurance at Methra Uppsala AB. With more than 30 years’ experience in regulatory affairs, she has worked at the Swedish Medical Products Agency (MPA) as well as small and large pharmaceutical and biotechnology companies. Since 2006, she has worked as a consultant in regulatory affairs and quality assurance for pharmaceuticals, advanced therapy medicinal products, medical devices and combination products through Methra Uppsala AB. She holds an MSc Pharm from Uppsala University, an MBA from the Stockholm School of Economics in Sweden, and an MSc MTRA from Cranfield University in the UK.

Speakers will include:

Anna Koptina Gültekin Head of Regulatory Affairs, Mendus, Sweden		Anna is Head of Regulatory Affairs at Mendus. Her specialism lies in the development of cell and gene therapies and advanced therapy medicinal products (ATMPs) for immune-oncology in the US and the EU. Her experience in this field includes regulatory strategies and expedited programmes including the US Food and Drug Administration’s (FDA) Regenerative Medicine Advanced Therapy, Fast Track Designations and Orphan Drug Designation programmes. Anna holds a PhD in Biotechnology from the All-Russia Research Institute of Agricultural Biotechnology.
Leonor Enes Scientific Officer - SME Office, EMA, The Netherlands		Leonor Enes is Senior Scientific Officer at the European Medicines Agency (EMA) where he works in its Regulatory Science and Innovation Task Force. She joined the EMA in 2004 as a Product Team Leader in the Anti-infectives Office. In 2016, she joined the Small-and Medium-sized Enterprises Office where she supports early interactions on product development and is actively involved in stakeholder engagement and training activities. She studied Pharmaceutical Sciences at Lisbon University and has a Master’s degree in Drug Regulatory Affairs from the University of Bonn, Germany.
Marjon Pasmooij Head of Science Department/Associate Professor Drug Regulatory Science, MEB/Utretcht University, the Netherlands		Marjon Pasmooij, is head of the Science Department at the Dutch Medicines Evaluation Board (MEB), Associate Professor Drug Regulatory Science at Utrecht University, and co-chair of the Regulatory Science Network Netherlands (RSNN). Marjon studied Cell Biology in Wageningen, and did her PhD at the Dermatology Department of the University Medical Center Groningen on a rare genetic skin disease. Marjon has been employed by the MEB in various roles since 2007. She worked as a clinical assessor for 10 years in the field of gynaecology and dermatology. Since 2018 she heads the Science Department, and her team coordinates the Regulatory Science activities where the MEB is involved in. She is also part of the EMA-HMA EU-Innovation Network, which facilitates the development of innovative medicines and associated technologies and aims to strengthen engagement with innovators, and is a member of the Therapeutic Scientific Committee of the International Rare Diseases Research Consortium (IRDiRC).
Thera Max-Mos Head National Clinical Trial Office, CCMO, the Netherlands		Thera Max-Mos has a background in Biology, graduating with a Master’s degree in 2001 from Leiden University. She then joined the pharmaceutical firm Tramedico as Medical Information Officer before joining Sanofi in 2004. Here, she was promoted seven times during her 18 years at the company, managing her own team and eventually the entire Clinical Trials Unit. In 2022, she started her current position as Head of the National Clinical Trials Office at the Central Committee on Research Involving Human Subjects (CCMO). In this role, Thera contributes her regulatory expertise in clinical trials to clinical service units across The Netherlands and acts as liaison between regulatory bodies in the Netherlands and corporations in the area of clinical studies.

 

Catering
Please visit one of the catering stands as indicated on the floorplan to enjoy a cup of coffee or tea during the networking break. Various snacks will also be served during the break. Tables and seating can be found throughout the exhibition floor.

Exhibitors
Don't forget to visit our wonderful exhibitors located throughout the exhibition floor during the break.

Networking
Catch up with old colleagues and make new connections during the break. 

Poster Display
On the exhibition floor, TOPRA are delighted to present a collection of scientific posters submitted by our members – be sure to check them out during the session breaks!

TOPRA Membership Lounge
If you are interested in learning about the opportunities TOPRA offers or just fancy a chat, please be sure to come visit the TOPRA membership lounge located near the entrance to the exhibition.

There are sofas and coffee tables to network at, and the TOPRA stand personnel will be more than happy to answer any queries you may have. There are also plenty of flyers and brochures to pick-up!

This is also where delegates can come and collect their souvenir TOPRA teddy bear and members can collect their TOPRA water bottle.

 

This session will explore how to successfully navigate the new EU HTA Regulation’s mandatory assessment of relative effectiveness occurring in parallel with MAA, with earlier consideration of HTA evidence needs during clinical development and regulatory strategy will be key.

Health Technology Assessment (HTA) is the determination of a health intervention’s value to inform decision-making, such as pricing and reimbursement. The EU HTA Regulation (HTAR) will take effect on 12 January 2025 for oncology drugs, ATMPs and medical devices, followed within 5 years by all centrally approved medicinal products. The mandatory Joint Clinical Assessment (JCA) of clinical relative effectiveness and safety will occur in parallel with the marketing authorisation application (MAA) and will have partly different evidence requirements than those for regulatory approval. Companies must take this into account already in earlier phases of clinical development, in order to be able to fulfil the JCA and to avoid delays in market access. A crucial component is the current treatment landscape at the time of MAA, which will determine the comparative analyses requested by HTA assessors. Joint Scientific Consultations (JSC)s are offered to support clinical development from an HTA perspective and may be given in parallel with EMA regulatory scientific advice, but only as long as the clinical studies and investigations are still open to amendment. As further comparative analyses may be required for JCA in addition to those studied in pivotal trials, indirect comparisons, real-world data and other sources of information can be relevant. The HTAR offers a possibility to shorten the path to market access and consequent patient benefit, by earlier integration in the clinical evidence generation. 


Session Lead:

Sigrid Klaar Medical Advisor, NDA Group, Sweden		Dr Sigrid Klaar is a former regulator and HTA agency medical advisor, MD, PhD, Specialist in Oncology, currently in consultancy at the NDA Group. As a former clinical assessor at the Swedish Medical Products Agency for 14 years, She has extensive experience from oncology drug approvals in the EMA centralised procedure, scientific advice at the Swedish Medical Products Agency, and drafting guidelines for industry in the EMA Oncology Working Party. She has 5 years of HTA experience from the Swedish Dental and Pharmaceutical Benefits Agency (TLV), having worked with national reimbursement applications as well as EUnetHTA and FINOSE joint clinical assessments. Deeply involved in the EU HTA regulation before and after its adoption, including with EUnetHTA 21.
Carlos Langezaal FTOPRA  Senior Director Regulatory Affairs, Premier Consulting, United States of America		Carlos Langezaal is Senior Director of Regulatory Affairs for Premier Consulting, a firm that provides strategic solutions and service to emerging biopharmaceutical companies from concept to commercialisation. With 30 years’ experience in regulatory affairs, Carlos has amassed a wealth of experience across all stages of global pharmaceutical development, from pre-investigational new drug application (IND) through to phase III registrational stages. He has been a member of TOPRA’s Symposium Working Party for many years, to which he has applied his knowledge and experience in regulatory strategy.

Speakers will include:

Chantal van Gils Vice President, Evidence & Value, SSI Strategy, the Netherlands		Chantal is a medical doctor (MD) with an MSc and PhD in Health Economics and Epidemiology. She has more than 15 years of experience in academic, industry and clinical research organisations.  Chantal has also led real-world studies (phase IV, registries, database studies, external control/comparator studies), health technology assessment evidence generation projects, hepatic encephalopathy (HE) modelling and market access, primarily in the fields of oncology and rare diseases.
Anne Willemsen Co-chair JCA subgroup | Senior Advisor, Dutch National Healthcare Institute, the Netherlands		Anne Willemsen holds Double Masters Degrees in Health Sciences specialising in both Health Technology Assessment (HTA) and Health Policy. From here, she undertook a range of research and project management roles within the Dutch National Healthcare Institute over the past eight years.  This has involved working for the European Network for Health Technology Assessment (EUnetHTA), where she has been leading the Secretariat coordinating Joint Clinical Assessments (JCA) and the joint workplan between HTA bodies and the European Medicines Agency (EMA). In April 2023, she was elected as the co-chair of the JCA group, a subgroup of the Member State Coordination Group on HTA.

Panellists will include:

Michael Berntgen  Head of Scientific Evidence Generation Department, EMA, The Netherlands

Michael Berntgen is Head of the Scientific Evidence Generation Department at the European Medicines Agency (EMA), Amsterdam.  This department aims to support the development of medicines to ensure generation of robust and relevant scientific evidence, also in collaboration with other stakeholders (e.g. patients, HTAs). Activities include the provision of scientific advice and methodology qualification, support to medicines for the paediatric population and for orphan diseases, as well as provision of expertise and support in translational sciences. Furthermore, the department monitors the portfolio related to human medicines, manages the PRIME scheme and facilitates collaboration with downstream decision-makers (HTA bodies and payers), to foster timely access to medicines. Michael is a pharmacist by training and holds a PhD as well as a Master of Regulatory Affairs. From 1999 to 2006, Michael worked in various positions in regulatory affairs in the pharmaceutical industry in Germany and in the UK. In 2006 he joined the German national competent authority BfArM as Scientific Administrator in the Scientific Advice unit. Following this assignment he moved to the European Medicines Agency in 2007 where he initially took up a position as Scientific Administrator in the Therapeutic Group "Anti-infectives" of the Safety and Efficacy sector, followed in September 2009 by the assignment as Head of Rheumatology, Respiratory, Gastroenterology and Immunology in this sector. From September 2013 he was heading the Scientific and Regulatory Management Department and from September 2016 the Product Development Scientific Support Department. In March 2020 he took over the current position as Head of the Scientific Evidence Generation Department.

 

Scientific advice is a long-standing, well-established process in the regulatory network and brings a number of benefits to drug developers. Over the years, additional topics and procedures have been added to the existing core process, so as to support the requirements of an ever-expanding regulatory framework, e.g. through broad advice, qualification procedures, scientific advice for biosimilars or on medicine repurposing, etc. In this session we will discuss some recent procedures offered by EMA, national regulatory agencies and HTA bodies. Parallel consultations of regulators and HTA experts provide advice in order to streamline the development program not only for marketing authorisation but also for determining the value of a new treatment and may be very helpful in answering different questions within the same clinical trial. A new pilot project introduced at the centralised level aims at harmonising the scientific recommendations given by the CHMP’s Scientific Advice Working Party with the requirements for approval of clinical trials, which is in the remit of national authorities. This joint advice intends to avoid differing conclusions in regards of the acceptability of a certain study design or features. Pre-CTA advice from the Clinical Trials Coordination Group, another pilot within the ACT EU initiative, provides consolidated technical, regulatory advice to applicants before the submission of a clinical trial application in the Clinical Trials Information System. Finally, it will be interesting to hear about the usefulness of the simultaneous national scientific advice procedure as perceived by the pharmaceutical industry and regulators.

Session Leaders:

Andrea Laslop Head of Scientific Office AGES, Austria		Andrea Laslop is Head of the Scientific Office at the Austrian Medicines and Medical Devices Agency, a business unit of the Austrian Agency for Health and Food Safety (AGES). Her focus in regulatory affairs falls on different types of centralised European procedures during drug development, marketing authorisation and lifecycle management. She has been a member of the European Medicines Agency (EMA) Scientific Advice Working Party since 2003, and served as a delegate in the the Committee for Medicinal Products for Human Use at the EMA between 2007 and 2022. Prior to this, she worked as a professor of pharmacology and toxicology at the Medical University of Innsbruck.
Sandra Lourenço MTOPRA Director of Regulatory Affairs Arriello, Ireland		Sandra Lourenço is the Director of Regulatory Affairs of Arriello Ireland. She holds a Bachelor of Science degree in Chemistry from the Science College of Oporto University and has more than 22 years’ experience in both the Pharmaceutical and Management Consultancy sectors. She started her career as a scientific investigator in the wine industry and moved into Pharma R&D in 2003 and then to Regulatory Affairs in 2007. Throughout her career, she has made significant contributions during the initial phases of medicinal product life cycles. Sandra has successfully led numerous Regulatory consultancy projects on a global scale. Her accomplishments include the submission of over five hundred new abridged Marketing Authorizations in the European Union, utilizing both National and European procedures, as well as for several non-EU countries. Additionally, Sandra has skillfully overseen the ongoing lifecycle maintenance of these products post-approval.

Speakers will include:

 

Marianne Lunzer CTCG Chair, AGES, Austria		Dr Marianne Lunzer is a medical doctor by training and obtained her Doctor of Medicine degree from the University of Vienna in 2003. Throughout her career she has specialised in activities ensuring the safe and effective use of medicines. She joined AGES in 2008 as a pharmacovigilance assessor, later serving as its safety assessor for clinical trials from 2017 to 2022. She was also a member of the drafting team for Commission Implementing Regulation (EU) 2022/20 which focused setting up rules and procedures in the safety assessment of clinical trials.
Sonia Pulido Sanchez HTA Project Manager and Co-Chair of the HTA Coordination Group Subgroup on Joint Scientific Consultations (JSC), AEMPS, Spain		Sonia Pulido Sanchez holds a Bachelor of Science Degree in Pharmacy from Complutense University of Madrid, a Masters degree in Business Administration in the Pharmaceutical and Biotechnological Industry from Talento-EPHOS Business School and a Diploma in Health Technology Assessment from UNED University. She started her career in clinical operations, focused in observational studies in neurology, phase II and III clinical trials for oncology and ophthalmology, among others. She was also an early adopter of Risk Based Monitoring strategies. She then moved into the Health Technology Assessment area at AEMPS, as a Project Manager for national HTA reports. She was actively involved in EUnetHTA 21 and later in the Joint Scientific Consultations Subgroup. She is currently the Co-Chair of the Joint Scientific Consultations Subgroup under the HTA Regulation working towards the successful implementation of the EU HTAR.
Peggy Sarah EU Regulatory Expert, Sanofi, France		Peggy Sarah is a European Regulatory Expert at Sanofi. She holds a Pharm D from the University of Paris Sud and a Master of Business Administration from the University of Edinburgh.  She has been working in the pharmaceutical industry for 30 years in various positions including national, regional and global roles. She has strong experience in global regulatory development strategies, interactions with Health Authorities, and pre-and post-marketing authorisation procedures in various therapeutic areas such as bone diseases and cardiology.
Yoana Nuevo-Ordóñez Head of Innovation Office, AEMPS, Spain		Yoana Nuevo-Ordóñez, is a Chemist by training and has a PhD on Analytical Chemistry and a 2-year post-doc at the National Institute of Standards and Technology (NIST) in the USA. She continued her career at a biopharmaceutical company in Spain being the head of the physico-chemical laboratory within the Quality Control Department. After this period she joined the Spanish Agency of Medicines and Medical Devices (AEMPS) in 2018. Yoana is currently the head of the Innovation Office and National Scientific Advice Unit within the AEMPS, and she is the Spanish representative in the EU Innovation Network (EU-IN Network), a group composed by members of National Competent Authorities (NCAs) innovation offices and also representatives from the EMA Innovation Task Force office (ITF), built to conceive and promote initiatives to foster the access of patients to innovative medicines. Within the EU-IN Network, Yoana was the leader of the pilots carried out within the STARS (Strengthening Training of Academia in Regulatory Science) project to accompany academic translational research, and coordinated several Horizon Scanning reports together with other NCAs. She is currently leading 2 EU-IN Network key projects: she is coordinating the Simultaneous National Scientific Advice (SNSA) pilot project together with the PEI (German NCA) and the FAMHP (Belgium NCA) representatives, and she is leading the European Repurposing Project Pilot together with EMA. This year she was also nominated to Co-Lead the “Regulatory Science, Innovation and Competiveness” theme within the European Medicines Agencies Network Strategy 2028 (EMANS 2028).

Panellists will include:

Jane Moseley  Senior Scientific Officer, EMA, The Netherlands

Responsible for administration of Scientific Advice, Protocol Assistance and qualification procedures at EMA since 2009, including developing procedures for parallel scientific advice with Health Technology Assessment bodies.  Professional background in ophthalmology, epidemiology and regulatory including clinical assessor at the MHRA for pharmacovigilance, clinical trials, and licensing. Currently registered with the General Medical Council, UK. Education: Medical degree Trinity College, Dublin, Masters in Epidemiology at the London School of Hygiene and Tropical Medicine and Diploma in pharmaceutical medicine, fellow of the Royal college of ophthalmologists in UK, the Royal college of surgeons/ophthalmology in Ireland, member of the faculty of pharmaceutical medicine UK.

 

Maurice Bancsi, Senior Regulatory Affairs Scientist at Celegence, will present, "Development of AI Pharma-Regulations in the EU and US."  Maurice's presentation will provide a high-level overview of the history of AI and focus on the development of legislation in the pharmaceutical industry, focusing on the EU and the US. The session will explore how AI and machine learning are being applied throughout the product lifecycle in the pharmaceutical industry. Maurice will also present a comparative analysis of the regulatory environment in the EU and the US, highlighting key similarities and differences in their respective approaches to AI within pharma.

Learning Outcomes:

Understand the direction of AI pharmaceutical legislation in the EU and the US.

Identify the key differences in AI regulatory approaches between the EU and the US.

Gain insights into the application of AI in drug development.

Speakers will include:

The focus of this session will be on practical implementation of the Clinical Trial Regulation (CTR) post-transition in a global context. Experience will be shared from usage of the Clinicial Trials Information System (CTIS) including transparency and disclosure requirements. The session will discuss challenges in navigating between the different EU regulations in relation to clinical trials and elements to consider in navigating a global trial beyond the current fragmented environment.

Session Leaders:

Christine Grew MTOPRA Director, Canopy Life Sciences, United Kingdom		Christine Grew PhD MBA is the Director at Canopy Life Sciences, where Christine has been since October 2022. Prior to this, Christine held various roles at AbbVie from 2011 to 2021, including Director of Clinical Trials and Clinical Trial Regulatory Group Head. With a background in Regulatory Affairs, Christine also worked at companies such as Catalent Pharma Solutions and Cyton Biosciences. Christine holds a Doctor of Philosophy (PhD) in Organic Chemistry from the University of Bristol and a Master of Business Administration (MBA) from Imperial College Business School.
Marén U. Koban Director, Global Regulatory and Scientific Policy, Merck Healthcare KGaA, Germany		Marén Koban is Director of Global Regulatory and Scientific Policy at Merck Healthcare KGaA, Darmstadt. She currently focuses on policy work around real-world data and evidence, clinical trial modernisation and digital health. She has more than 15 years of experience across biologicals and small molecules gained at various global pharmaceutical enterprises. Marén holds a PhD in Molecular Biology from Imperial College London, a Master’s degree in Drug Regulatory Affairs from Bonn University and a German Diploma in Chemistry.

Speakers will include:

Pierre-Frédéric Omnes FTOPRA Executive Director, Life Sciences, Transperfect , France		Pierre-Frédéric Omnes is Executive Director at TransPerfect Life Sciences. He has more than 20 years’ experience working in global contract research organisations and pharmaceutical companies as a Regulatory Affairs Consultant, where he has overseen numerous multinational clinical trial applications globally. He is a subject matter expert on site startup and regulatory operations in global clinical trials as well as on the EU Clinical Trial Regulation 536/2014 (EU-CTR) for the readiness and implementation of the Clinical Trial Information System (CTIS).
Seán Byrne Senior Manager, Legal & Regulatory Affairs, EUCOPE - European Confederation of Pharmaceutical Entrepreneurs, Belgium		Dr Seán Byrne is Senior Manager, Legal & Regulatory Affairs for the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE). Seán represents EUCOPE members at relevant European Medicines Agency and EU institutional fora. He coordinates membership engagement through the Regulatory Working Group and several topic-specific focus groups, as well as in inter-trade association settings. His role involves guiding the development of EUCOPE's positions on all legislative and policy files related to medicines' regulation throughout the product life-cycle. Prior to joining EUCOPE Seán worked in Brussels-based trade associations and consultancies, advising innovative pharmaceutical companies on EU and international legislative and policy files.
Marianne Lunzer CTCG Chair, AGES, Austria		Dr Marianne Lunzer is a medical doctor by training and obtained her Doctor of Medicine degree from the University of Vienna in 2003. Throughout her career she has specialised in activities ensuring the safe and effective use of medicines. She joined AGES in 2008 as a pharmacovigilance assessor, later serving as its safety assessor for clinical trials from 2017 to 2022. She was also a member of the drafting team for Commission Implementing Regulation (EU) 2022/20 which focused setting up rules and procedures in the safety assessment of clinical trials.
Francesca Scotti CTIS – Transparency Lead, EMA, The Netherlands		Francesca Scotti is a pharmaceutical chemist, who worked for pharmaceutical industries in the field of compliance of clinical trials before joining EMA in 2016. At EMA, she first started working in the Human medicines division as a procedure manager, and then in 2019 she joined the clinical trials team, becoming the business responsible of the EudraCT database, where she particularly focused on supporting sponsors in raising their compliance with clinical trials’ results posting requirements. During the last year, she has also been leading the implementation of the revised transparency rules in the CTIS public portal. The revised CTIS transparency rules give early access to key clinical trial information to stakeholders including patients and healthcare professionals, while introducing process simplifications that benefit sponsors who have to protect commercially confidential information and personal data.
Oskia Bueno Zaragüeta Scientific Administrator, EMA, the Netherlands		Oskia Bueno Zaragueta has a Licentiate degree and a Master’s degree in Chemistry, both from the University of Navarra, as well as a PhD in Medicinal and Pharmaceutical Chemistry from the Universidad Complutense de Madrid and an MBA from the ESAME Pharmaceutical Business School. She worked for ten years in research while completing her education, before joining the Foundation for Biomedical Research Health Research Institute at the San Carlos Clinical Hospital as a Clinical Trials Associate and later as a Clinical Trials Manager. Oskia then moved to the European Medicines Agency in the role of Scientific Administrator.

Panellists will include:

Andrea Seidel-Glatzer Head of Project Management, Universitätsklinikum Heidelberg, Germany

Andrea Seidel-Glätzer is Head of Project Management at the Coordination Centre for Clinical Trials at the University Hospital Heidelberg (KKS), Germany. She has almost 15 years of experience in clinical trials in academic environment. Before joining the KKS Andrea gained some experience in the pharmaceutical industry and a CRO. KKS acts with more than 90 staff members as an academic CRO and provides services to support mainly investigator initiated clinical trials in academic institutions, but also for smaller industries. In March 2020 Andrea joined EMA´s Clinical Trial Information System testing as a representative of the academia on behalf of the German KKS-Network/ECRIN and is now a CTIS Subject Matter Expert (SME) and Member of the CTIS Simplification Task Force. She is also leading the Project Management working group of the German KKS-Network, an association and non-profit organisation of academic coordinating centres for clinical studies in Germany.

A topic which requires no introduction and now a Symposium staple, patient experience data and its use in the evaluation of medicinal products will be the focus of this year’s discussion. Following an EMA workshop held in recent years, the definition of what patient experience data includes was proposed. However, patient experience data (PED) is not yet used systematically as part of a medicine’s development and evaluation. This session will put this up for discussion, we will hear from EMA officers what the current thinking is in light of a forthcoming reflection paper to be issued in 2024 as well as from representatives of the industry and most importantly patient representatives themselves. Could patient experience data, i.e. data coming directly from patients, such as Patient Reported Outcomes (PROs), Patient preference studies (PPS), or data from Patient Engagement, become a key decision making factor in future medicine evaluations?

The session will provide an update of progress from EMA on this topic and we will discuss and hear the views and expectations from patients and industry representatives.

Session Leaders:

Francesca Buttigieg MTOPRA Regulatory Affairs Professional, Switzerland		Francesca has volunteered with TOPRA since 2013 in a number of CRED courses and in organising the annual Symposium. She subsequently took on the role of Chair of the working party for the Human Medicines Symposium. She holds an undergraduate degree in pharmacy and an MSc in regulatory affairs. She entered into regulatory affairs in 2008 with various roles in the generics field. She then moved to the novel pharma space in 2013. Since then, she has been responsible for gaining regulatory approvals, supporting and maintaining marketing authorisations for various oncology products in Europe, Middle East and Africa.
Juan Garcia Burgos Head of Public and Stakeholder Engagement, European Medicines Agency (EMA), the Netherlands		Juan García Burgos is a Qualified Medical Doctor from the University of Autonoma in Madrid, specialised in urology. Juan worked as a urologist surgeon at the hospital Gregorio Maranon in Madrid. He joined the European Medicines Agency (EMA) in 2002 in the scientific units and was responsible for coordinating the preparation of EU clinical guidelines for drug development. He took up new responsibilities in 2005 where he was appointed Head of Medical and Health Information. In January 2017, he was appointed Head of Public and Stakeholders Engagement Department and is Co-chair of the EMA patients’ and healthcare professionals’ working party.

Speakers will include:

Susan Bhatti Director EU Global Regulatory and Scientific Policy, Merck BV, The Netherlands		Susan Bhatti has been working in pharmaceutical and clinical research industries for more than 25 years. She is Director of Global Regulatory and Scientific Policy at Merck BV where she supports the development of regulatory and scientific policies in Europe. She chairs the Clinical Research Expert Group at the European Federation of Pharmaceutical Industries and Associations (EFPIA) as well as a co-chairing a subgroup focused on patient engagement. She is currently co-leading the multi-stakeholder initiative on cross-border access to clinical trials in Europe (EU-X-CT), which is a joint undertaking by the European Forum for Good Clinical Practice (EFGCP) and EFPIA.
Kaisa Immonen Patient and Consumer Liaison, EMA, The Netherlands		Kaisa Immonen joined the Stakeholders and Public engagement team of the European Medicines Agency (EMA) in 2023. She supports interactions with patients, consumers and healthcare professionals and their organisations. Kaisa holds a Master’s in Health Policy, Management and Innovation from Maastricht University and a Master’s in International Relations. She has extensive experience of EU health policy and patient advocacy: she was Director of Policy at the European Patients’ Forum in 2010-2013 and co-chaired the EMA Patients and Consumers Working Party 2016-2022. She also contributed to OECD work on quality and safety of healthcare, the OECD PaRIS surveys, WHO Europe’s work on people-centred health systems, as well as numerous European projects, working groups and networks on health policy.
Maria Cavaller-Bellaubi Patient Engagement & Therapeutic Development Director, EURODIS-Rare Diseases Europe, Spain		Maria Cavaller-Bellaubi joined EURORDIS in 2018 and manages the process of patient engagement in medicines development procedures at the European Medicines Agency (EMA), mainly protocol assistance; and patient expert on the Committee for Orphan Medicinal Products (COMP) at the EMA.  She coordinates the group of high-level EURORDIS representatives/volunteers who sit on the various scientific committees/working parties at the EMA, known as the EURORDIS Therapeutic Action Group, and work on topics linked to patient engagement, therapeutic development, regulatory policy and access to medicines. Maria holds a degree in Pharmacy (PharmD) and a Sc. MBA in Health Economics and Global Market Access.

 

 
Speakers will include:

Michael Kipping Director, Medical Technologies EMEAA, Element, United Kingdom

Carlos Langezaal FTOPRA  Senior Director Regulatory Affairs, Premier Consulting, United States of America