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Symposium 2024 Programme

*Please note that the programme is subject to change, and further information will be provided in due course.

For information about each session, click on the titles below.

Human Medicines Symposium Programme

Monday 30 September 2024

More information to come soon.


Speakers will include:



Kevin Pay

Chief Executive, TOPRA,
United Kingdom


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

Paula Loekemeijer
Chief Executive,
MEB, the Netherlands

Session Leaders:



Sabine Haubenreisser
Principal Scientific Administrator - Stakeholders and Communication
EMA, Germany


Roelie Marinus
Senior Policy Advisor
MEB, the Netherlands

Speakers will include:
 Aimad Torqui
Head of Division Medicines Evaluation Board,
MEB, The Netherlands
 

 

This is a valuable opportunity to explore our wide range of exhibitor stands and network with fellow delegates!


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.

Complex and inconsistent requirements across Europe, unnecessary red tape, and 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
Director EU Global Regulatory and Scientific Policy,
Merck BV, The Netherlands 
Katarina Nedog
Associate Director,
EFPIA, Belgium


Speakers will include:

 

Lada Leyens
Senior Director - EUCAN regulatory TA head
GI2, Takeda, Switzerland
 



This is a valuable opportunity to explore our wide range of exhibitor stands and network with fellow delegates!


Until a few years ago the trending hashtags were blockchain, real world evidence, and accelerated pathways. Soon after, Parallel advice and HTA 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 in keeping up with the times and health agencies are no different. EMA and FDA have 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 - Stakeholders and Communication
EMA, Germany 


Francesca Buttigieg
Director of Regulatory Affairs
PTC Therapeutics, Switzerland  


Speakers will include:



Ton de Boer
Chairman of MEB Board,
MEB, The Netherlands
 


Steffen Thirstrup
Chief Medical Officer,
EMA, The Netherlands
 

 

End of Human Medicines Symposium Day 1

Tuesday 1 October 2024


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.

Session Leaders:



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

Katja Pečjak MTOPRA
Director BD, Sales and Marketing, Industry Subject Matter
Expert in EMA/HMA ePI Pilot Project, Billev Pharma East, Slovenia
 

This is a valuable opportunity to explore our wide range of exhibitor stands and network with fellow delegates!

 


Speaker:
 

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

 

Speakers will include:



Kevin Pay
Chief Executive, TOPRA
United Kingdom 


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


Aman Khera FTOPRA
Vice President, Regulatory Science, Strategy and Innovation
Worldwide Clinical Trials, Canada 


 

This is a valuable opportunity to explore our wide range of exhibitor stands and network with fellow delegates!

 


Speakers will include:



Kevin Pay
Chief Executive, TOPRA
United Kingdom  


Margareth Jorvid FTOPRA
CEO, Regulatory Affairs & Quality Assurance
Methra Uppsala AB, Sweden 

 


This session will look into opportunities and challenges with application procedures and performing a combination 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 CTIS, while the device/diagnostic follow different national procedures. An update on the COMBINE project will be included.

Session Lead:



Margareth Jorvid FTOPRA
CEO, Regulatory Affairs & Quality Assurance
Methra Uppsala AB, Sweden 
 


Speakers will include:

 

Vladimir Vujovic
Director,
IQVIA, Serbia
 

Olga Tkachenko
Policy Officer,
European Commission, Belgium


Elin Karlberg
Head of Regulatory Group, Medical
Products Agency/Läkemedelsverket, Sweden

This is a valuable opportunity to explore our wide range of exhibitor stands and network with fellow delegates!

AI/ML tools are impacting every aspect of the medicines lifecycle. But how is AI/ML being used by Regulatory Professionals, both within industry and health authorities, to support their work? How will its use be overseen? And will it shape the skills of the Regulatory Professional of the future?

Session Leaders:



Carla Jonker
Senior Regulatory Project Leader / Scientific
Administrator, CBG-MEB/EMA, the Netherlands
 Rebecca Lumsden MTOPRA
Head of Regulatory Science and Policy,
EU/AMEE region, Sanofi, United Kingdom

End of Human Medicines Symposium Day 2

Wednesday 2 October 2024


Clinical evidence generation for healthcare products has advanced to include a range of 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).   

Over the last two decades, the EU clinical trials environment has undergone significant changes intended to simplify and harmonize the administrative provisions governing EU clinical trials but obstacles persist that hamper the conduct of multinational trials in the EU. Progress continues to be made to work in partnership to optimize the implementation of the EU CTR and the related launch of the single EU portal and clinical trial database, CTIS.  The ACT EU initiative aims to support further transformation of the clinical trials environment in the EU. With several priority actions covering different aspects of clinical trials, the main goal of ACT EU is to contribute to the health of EU citizens through faster access to innovative medicines and optimized use of medicines on the market.  

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 probe the interface between the EMA/HMA’s ACT EU and Big Data Initiatives and how these link into a broader strategic vision for the EU medicines regulatory network. The panel will consider not only how science is evolving but also the complexity of clinical trial execution in a rapidly changing landscape. 

Session Lead:



Álmath Spooner
Head of Europe Regulatory Policy and Intelligence
AbbVie, Ireland 
 

Denise Umuhire
Pharmacoepidemiology & RWE Specialist,
EMA, the Netherlands

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
CEO, Regulatory Affairs & Quality Assurance
Methra Uppsala AB, Sweden
 

Speakers will include:



Anna Koptina Gültekin
Head of Regulatory Affairs,
Mendus, Sweden



Marjon Pasmooij
Head of Science Department,
MEB, the Netherlands

 


This is a valuable opportunity to explore our wide range of exhibitor stands and network with fellow delegates!

 

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

Session Lead:



Sigrid Klaar
Medical Advisor and Advisory Board
Member, NDA Group AB, Sweden
 

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

Speakers will include:



Chantal van Gils
Vice President, Evidence & Value,
SSI Strategy, the Netherlands

 

 

 

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 SAWP/CHMP 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. Finally, it will be interesting to hear about the usefulness of the simultaneous national scientific advice procedure as perceived by the pharmaceutical industry.

Session Leaders:



Andrea Laslop
Head of Scientific Office
AGES, Austria 


Sandra Lourenço MTOPRA
Head of Regulatory Affairs
Arriello, Ireland

Speakers will include:

 

Alexa Hunter
Director EU Global Regulatory and Scientific
Policy, Merck KGaA, Germany
 

 


This is a valuable opportunity to explore our wide range of exhibitor stands and network with fellow delegates!

 

Focus of the session will be on practical implementation of the Clinical Trial regulation post transition in a global context. Experience will be shared from usage of 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 of Regulatory Affairs,
Canopy Life Sciences, United Kingdom
 

Maren Koban
Director, Global Regulatory and Scientific
Policy, Merck Group, Germany

Speakers will include:

 

Pierre-Frédéric Omnes
Executive Director,
Transperfect , France 
 

Seán Byrne
Senior Manager, Legal & Regulatory Affairs, EUCOPE - European
Confederation of Pharmaceutical Entrepreneurs, Belgium

 


Session Leaders:
 

Josephine Tapper
 
Lay advisor - Medicines and Healthcare Products Regulatory Agency
(MHRA) and EUPATI fellow, EUPATI, United Kingdom
 

Juan Garcia Burgos
Head of Public and Stakeholder Engagement,
EMA, The Netherlands

 
 
Speakers will include:


Kevin Pay

Chief Executive, TOPRA,
United Kingdom


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

End of Human Medicines Symposium Day 3

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