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:

Rick Clayton Technical Director,  AnimalhealthEurope, Belgium		Rick Clayton is Technical Director for AnimalhealthEurope, Brussels. He has worked for the European industry association since 1997 and comes from a background in product development and registration. In this role, he is in regular dialogue with decision makers within the European institutions and the European medicines regulatory network with the principle aim of supporting the smooth operation of regulatory systems. He is also coordinator for the European industry representation to the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (“VICH”).  He has a degree in Applied Biology and a diploma in Marketing.
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.

 
The One Health session will bring together experts from organisations intimately involved in tackling the interconnected challenges of human, animal, and environmental health. We are privileged to hear from the Netherlands Chief Veterinary Officer on their national activities, from the World Organisation for Animal Health (WOAH) on international activities, and from the European Medicines Agency (EMA) on the development of a joint Framework for Action on One Health with the European Food Safety Administration (EFSA), the European Chemical Agency (ECHA), the European Environment Agency (EEA) and the European Centre for Disease Prevention (ECDC). Among the important topics to be discussed is antimicrobial resistance, emphasizing the imperative for collaborative strategies to mitigate this global threat.

12:40 – Introduction 

12:45 – Zoonotic Disease Survellience and Control Strategies; Emerging Diseases - Hendrik Jan Roest

13:05 – Collaboration to combat antimicrobial resistance - Mária Szabó 

13:25 – Joint framework for action on One Health by five EU agencies – Ana Vidal

13:45 – Panel Discussion

Rick Clayton Technical Director, AnimalhealthEurope, Belgium

Rick Clayton is Technical Director for AnimalhealthEurope, Brussels. He has worked for the European industry association since 1997 and comes from a background in product development and registration. In this role, he is in regular dialogue with decision makers within the European institutions and the European medicines regulatory network with the principle aim of supporting the smooth operation of regulatory systems. He is also coordinator for the European industry representation to the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (“VICH”).  He has a degree in Applied Biology and a diploma in Marketing.

Speakers will include:

Ana Vidal One Health Senior Scientific Specialist, European Medicines Agency (EMA), the Netherlands		Ana Vidal graduated as a veterinarian in 1999, holds a PhD on Infectious diseases and a master’s degree in Epidemiology. Her area of expertise includes food safety, zoonotic diseases and other public health issues such as AMR. Ana has held different scientific and policy positions both in academia and government organisations. She joined the Veterinary Division at the EMA in 2020 as an AMR Scientific Senior Specialist. Currently, she is part of the Veterinary Strategy and Support Office where she provides support and strategic advice on One Health issues and is the EMA representative to the Cross-agency One Health Task Force.
Mária Szabó Scientific Coordinator, WOAH, France		Dr Mária Szabó obtained her veterinary degree at the Veterinary Science University in Budapest. Since 2015, she has been working for the Word Organisation of Animal Health (WOAH) where she works as its scientific coordinator. She previously worked in the Hungarian public sector as part of the Veterinary Medicines Directorate. For 15 years, she was a National Expert to the European Medicines Agency (EMA). She also acted as a secretary to the Co-ordination Group for Mutual Recognition and Decentralised Procedures.
Hendrik Jan Roest Chief Veterinary Officer, Dutch Ministry of Agriculture, Fisheries, Food Security and Nature, The Netherlands		Hendrik-Jan Roest graduated from Utrecht University Veterinary School in 1996 and worked for six and-a-half years as a veterinary practitioner. In 2003, he switched to Wageningen Bioveterinary Research (WBVR) in Lelystad to specialise in veterinary microbiology. Between 2005 and 2012, he was head of the Laboratory for General Bacteriology. Hendrik-Jan is the initiator of Q fever research at WBVR and isolated Coxiella burnetii for the first time in the Netherlands. This led to his PhD thesis entitled “Coxiella burnetii in pregnant goats” in 2013. Between 2012 and 2019, Dr Roest was the head of several departments at WBVR, as well as member of the Management Team of WBVR. He was quartermaster of the Netherlands Centre for One Health (NCOH) and NCOH and Wageningen Research representative and project management team member of One Health EJP, a Horizon 2020 project. Since April 2019, Hendrik-Jan has been deputy Chief Veterinary Officer of the Netherlands at the Dutch Ministry of Agriculture, Fisheries, Food Security and Nature. Since February 2021 he has been affiliated to the Faculty of Veterinary Medicine at Utrecht University, department of clinical infectiology to continue to be connected to his specialisation in veterinary microbiology as a diplomat of the European College of Veterinary Microbiology.

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.

Since the new regulation started to apply on 28 January 2022 there have been major changes in our regulatory affairs. The introduction of  the UPD substantially impacted how processes are handled for both MAHs and NCAs. Also posing other challenges are the resolution of data quality issues, and the first SPC harmonisation procedures. In this session we will discuss the impact of the new regulation on several topics and from different perspectives. Are we already profiting from the intended objectives of the new regulation or are we still lost in administrative burden? Speakers from NCAs and Industry will share their views on these topics.

14:50 – Introduction

14:55 - CMDv update; including the VNRA list and SPC harmonisation – Beate Gasser

15:15 – Practical experience so far with 2019/6 - Stéphanie Galleau 

15:35 – SPC harmonisation – first experience - Kristina Bergström

15:55 – Panel Discussion 

Session Lead:

Rico Slingerland Regulatory Project Leader, Medicines Evaluation Board (MEB), the Netherlands

After studying Animal Science and Management at Wageningen University & Research, Rico Slingerland began his career as a researcher in agricultural groundwater at the National Institute for Public Health and the Environment for The Netherlands. He joined the Medicines Evaluation Board (MEB) in 2009 as a Regulatory Project Officer and was promoted to Project Leader in 2011. In 2021, Rico became the Dutch representative for the Union Product Database at the MEB.

Speakers will include:

Beate Gasser CMDv Member AT, Regulatory Expert, AGES, Austria		With a Master's degree in Biology and Zoology from the University of Vienna, Beate Gasser has built a distinguished career in regulatory affairs within the realm of healthcare and medicinal products. Since 2006, she has served as an expert in regulatory affairs at the Austrian Federal Office for Safety in Health Care (BASG). She has been an Austrian member of the European Medicines Agency’s (EMA) Communication and Tracking System (CTS) Working Group since 2008, assuming the role of vice chair in 2018. That same year, she also started her post as vice chair of the EMA’s Coordination group for mutual recognition and decentralised procedures for veterinary medicinal products (CMDv), having joined as a member in May 2014.
Kristina Bergström Senior Regulatory Affairs Manager, Orion Corporation ORION PHARMA, Finland		Kristina Bergström was educated in pharmacy at Åbo Akademi University in Turku. She began her career as a pharmacy technician in 1997. After being promoted to pharmacist, she moved into regulatory affairs. Kristina has worked at Orion for 22 years; Orion is a global pharmaceutical company based in Finland which develops human and veterinary medicines. Having started as a Regulatory Affairs Assistant, Kristina has held several roles at Orion and is now Senior Manager of Regulatory Affairs for veterinary medicinal products.
Stéphanie Galleau Senior Regulatory Affairs Manager, Boehringer Ingelheim Animal Health, France		Stéphanie Galleau holds a Doctor of Veterinary Medicine degree from the Veterinary School of Lyon in France (1997-2002). Stéphanie has more than 20 years of experience within the Animal Health pharmaceutical industry. Currently, Stéphanie is Senior Regulatory Affairs Manager at Boehringer-Ingelheim Animal Health, France, where she is involved in the new registrations and the maintenance of marketing authorisation for biologicals in the European Union and primary markets. Previously, she was Clinical Leader in the same company, where she led clinical development of new vaccines for production animals and acted as Study Director in both exploratory and development 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.

It is another busy year for product information. Quarter 3 2024 will be the halfway mark of the transitional period to align existing product information with Regulation (EU) 2019/6. There are continuous initiatives to simplify this exercise and our speakers will comment on the latest updates. The new implementing acts on small immediate pack size and on pictograms/abbreviations came into effect in May, each with their own transitional arrangements and accompanying variations (VNRAs). Looking ahead, the delegated act on oral administration comes into effect towards the end of next year and will require a more involved review of product information falling within its scope. Quality Review of Documents (QRD) template v.9.1 will be adopted in 2024 to take account of these 3 new legal acts. The opportunities offered by Electronic product information (ePI) will be explored, and this is also an opportunity for delegates to raise veterinary-specific considerations to this project.

17:00 – Introduction 

17:05 - Alignment with QRD v.9.0. Latest considerations from CMDv – Rhona McHugh 

17:25 - QRD v.9.0 progress and challenges; will we make it on time; impact of 3 new legal acts – Natalie Miller 

17:45 - Status of EMA e-PI project – Elizabeth Scanlan

18:05 – Panel Discussion 

Session Lead:

Emily Drury Head of Department, Veterinary Surveillance and Regulatory Support, European Medicines Agency (EMA), the Netherlands

Emily Drury holds an MSc degree in Biological Sciences from the University of Oxford. She has more than 20 years’ experience in European veterinary regulatory affairs. For the first nine years of her career, she worked in the regulatory consultancy, Cyton Biosciences, across several areas for veterinary medicines and feed additives before leading their regulatory projects team.  In 2009, she joined the European Medicines Agency, initially as CMDv Secretary and Project Manager for post-authorisation procedures, and subsequently as Head of the Veterinary Regulatory and Organisational Support Service. She now leads the newly formed Regulatory Affairs and Referrals Service within the Veterinary Division.

Speakers will include:

Rhona McHugh Executive Pharmaceutical Assessor, Health Products Regulatory Authority (HPRA), Ireland		Rhona McHugh has a PhD in Pharmacology from University College Dublin. She worked for a number of years in the medical devices sector before joining the HPRA in 2008. She is an Executive Pharmaceutical Assessor with the HPRA and has been the Irish delegate at CMDv for the last 7 years.
Natalie Miller Senior Director, Global Regulatory Affairs Pharmaceuticals, EU, Elanco Animal Health Inc., Switzerland		Natalie Miller holds a PhD in Organic Chemistry from the Australian National University and spent several years working in research and development positions in both academia and industry prior to joining Elanco in 2015, where she started her career in regulatory affairs. She has held roles of increasing responsibility within Elanco where she currently serves as Senior Director for Global Regulatory Affairs Pharmaceuticals for the EU. In this role, Natalie leads the European-based team responsible for the development, registration and lifecycle management of pharmaceuticals, feed additives and biocidal products in the EU.
Elizabeth Scanlan Scientific Communication Officer & ePI Product Owner, European Medicines Agency (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.

Regulation (EU) 2019/6 has introduced significant changes to the way pharmacovigilance for veterinary medicines is performed. More than two years since the Regulation became applicable have passed, and the implementation phase for pharmacovigilance processes is coming to an end, but clarifications are still coming. In this session, you will hear about the status of the systems and procedures tested and implemented by the Committee for Veterinary Medicinal Products (CVMP)/Coordination group for mutual recognition and decentralised procedures for veterinary medicinal products (CMDv) Pharmacovigilance Working Party and its Pilot Signal Management Expert Group, a perspective from industry on the practical implementation of signal management and consideration of challenges ahead. The session will also provide information on the Data Quality Framework for Adverse Drug Reaction reporting and first observations arising from veterinary Pharmacoviglance Inspections.

09:00 – Introduction 

09:05 - Status of veterinary pharmacovigilance systems and procedures implementation and PhV inspections – Anita Bottger

09:25 – Navigating Post Authorization Obligations with impact on Pharmacovigilance - Industry experience – Alexandra Grill 

Session Lead:

Jana Schalansky Head of Veterinary Strategic Support Office, European Medicines Agency (EMA), the Netherlands

Jana Schalansky holds a BA in Business Administration and Psychology from Europäische Fernhochschule Hamburg. She joined the European Medicines Agency (EMA) in 2003 as an assistant in the Veterinary Medicines Division and has subsequently worked in various roles in the division. From 2016, she held the role of programme manager for the EMA’s Veterinary Change Programme where she supported the preparation and implementation of the Veterinary Medicinal Products (VMP) Regulation. In 2021, she was appointed head of the EMA’s newly created Veterinary Strategic Support office where she provides strategic advice to all levels of management at the division.

Speakers will include:

Anita Bottger Vice-Chair of the CVMP/CMDv Pharmacovigilance Working Party (PhV WP-V), Medicines Evaluation Board (MEB), the Netherlands		Anita graduated as a veterinarian in 1990 from Utrech University, where she has worked in practice and conducted research. From 2011, she worked as an efficacy and safety assessor for veterinary medicines at the Medicines Evaluation Board (MEB) for six years before becoming MEB’s coordinator for veterinary affairs and pharmacovigilance. In this role, she conducts pharmacovigilance assessments and analyses using signal evaluation in the European Medicines Agency’s (EMA) pharmacovigilance database. She also serves as a pharmacovigilance inspector where she inspects the pharmacovigilance systems for Dutch marketing authorisation holders.
Alexandra Grill Senior Specialist Global Pharmacovigilance, MSD Animal Health, Germany		Dr. Alexandra Grill holds a Doctor of Veterinary Medicine from the University of Regensburg and Ludwig-Maximilians-University Munich (2014-2017) and a degree in Veterinary Medicine from Stiftung Tierärztliche Hochschule Hannover (2008-2014). Currently, Dr. Grill serves as Associate Director and Team Lead of Global Regulatory Affairs at MSD Animal Health Innovation GmbH in Schwabenheim. Previously, she was a Senior Specialist in Global Pharmacovigilance at the same company (2019-2024), where she led risk management and acted as a Subject Matter Expert for the EMA PV System. Dr. Grill began her career as a Veterinarian and Postdoc at University Medical Center Mainz (2017-2019).
Tom Paternoster-Howe Data Science Specialist, European Medicines Agency (EMA), the Netherlands		Tom Paternoster-Howe has over 20 years of experience in pharmacovigilance, within both the pharmaceutical industry and as a regulator. Tom has a strong track record of creating ensuring high quality ADR data through the creation of new processes and guidelines to ensure that the best data is available for pharmacovigilance decision-makers. Tom is a frequent speaker at conferences. He holds a Master's degree in Toxicology and has been specialising in the quality of ADR data at EMA for 20 years.

 

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:

Prof. 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 Kickbusch 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".

 

Speakers will include:

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

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

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.

 

Regulatory science is evolving (relatively) fast on the veterinary side, not just through scientific developments, but also through new approaches to risk assessment.  This session will explore three areas where approaches are being influenced by new knowledge and developments, to discuss questions such as:  How should the environmental risk assessment of pet parasiticides evolve to provide greater reassurance of environmental safety without losing this important class of products?  What recent regulatory developments in the regulatory framework are most relevant to the product development and registration of new products in Europe? How has Regulation 2019/6 changed the way innovators approach potential new product developments?  What recent regulatory developments are most relevant to the development and registration of new products in Europe?  Have new approaches to the evaluation of regulatory data for vaccines helped vaccine developers, and what is being done to reduce the use of laboratory animals in vaccine batch control?

13:30 – Introduction 

13:35 – Potential for new ERA (exposure assessment) for pet parasiticides – Johan Schefferlie 

13:55 – Recent regulatory developments relevant to innovation – Raffaele Bruno 

14:15 - VAMF and PTMF - a MAH perspective and experience – Klaas Medendorp 

14:35 – Panel Discussion  

Session Lead:

Ivo Claassen Head of Veterinary Medicines Division, EMA, the Netherlands

Dr Ivo Claassen is head of the Veterinary Medicines Division and Deputy Executive Director at the European Medicines Agency. Since he joined the Agency in 2018, he has been responsible for the implementation of Veterinary medicinal products regulation. Furthermore, he was involved in the development of the Veterinary Regulatory Science Strategy and the EMA Veterinary Big Data strategy. He has also over 30 years of experience in vaccine production, QC/QA, R&D and regulatory affairs, both for human and veterinary vaccines.

Speakers will include:

 

Raffaele Bruno Associate Director Regulatory Affairs, Zoetis, Belgium		Raffaele joined Pfizer Animal Health (now Zoetis) in 2011, where he works on the registration of new veterinary medicinal products for both companion animals and livestock in the EU. At Zoetis, Raffaele has led the European Research and Design (R&D) Regulatory Affairs team for pharmaceuticals since 2019. He is also involved in the global research and development strategies of new Zoetis veterinary medicinal products. Raffaele holds a Doctor of Veterinary Medicine degree from the University of Bologna in Italy and a Master’s degree in Drug Innovation and Regulatory Science from the University of Utrecht in the Netherlands.
Klaas Medendorp Director, Regulatory Affairs, Global RA Biologicals, MSD Animal Health, the Netherlands		Klaas Medendorp is a seasoned professional with 15 years of experience in regulatory affairs within the pharmaceutical industry. Klaas has a strong track record of navigating complex regulatory landscapes and driving successful product approvals. He holds a PhD degree in Medical Sciences and is currently serving as a Director in the Global Regulatory Affairs Biologicals department at MSD Animal Health.
Johan Schefferlie  Chair of the Committee for Veterinary Medical Products (CVMP), MEB, the Netherlands		Johan Schefferlie is the chair of the CVMP. Biologist by training, Johan has been a Senior Regulatory Project Leader at the Dutch Medicines Evaluation Board since 2007. With extensive experience in toxicological and consumer risk assessment of residues of veterinary drugs in food of animal origin, he has collaborated as an expert for the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), the European Food Safety Authority and the Joint WHO/FAO Expert Committee on Food Additives (JECFA), co-authoring several reports.

Panellists will include:

Haru Kroneis Head of Department HEVE (Herbal, Homoeopathic and Veterinary Medicinal Products), AGES, Austria

Haru Kroneis graduated from the Vienna University of Technology’s Technical Chemistry degree programme with a specialisation in Chemical Engineering and Environmental Technology, as well as from the Medical University of Vienna’s Toxicology postgraduate programme. She is a European Registered Toxicologist.  For the first 10 years of her professional career, she worked in the fields of environmental analytical chemistry and atmospheric chemistry. The following ten years of her professional life, she worked in research and development in the pharmaceutical industry. Since 2018, she has been working for the Austrian Medicines and Medical Devices Agency, where she is currently leading the Department Herbal, Homoeopathic and Veterinary Medicinal Products in the Institute Marketing Authorisation of Medicinal Products & LCM. Since June 2020 she has been member of the EMA/CVMP’s Environmental Risk Assessment Working Party (ERAWP).

 

Speakers will include:

Rick Clayton Technical Director, AnimalhealthEurope, Belgium

Rick Clayton is Technical Director for AnimalhealthEurope, Brussels. He has worked for the European industry association since 1997 and comes from a background in product development and registration. In this role, he is in regular dialogue with decision makers within the European institutions and the European medicines regulatory network with the principle aim of supporting the smooth operation of regulatory systems. He is also coordinator for the European industry representation to the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (“VICH”).  He has a degree in Applied Biology and a diploma in Marketing.