The conference “Advancing the 3Rs for Regulatory Testing of Medicines” is part of the 2024 Belgian Presidency of the Council of the European Union and will take place on Wednesday January 31, 2024 at Flanders Meeting and Convention Center in Antwerp.
The conference aims to:
- promote the past and current contributions of the FAMHP and its stakeholders to apply the 3R principles in the regulatory testing of medicinal products for human and veterinary use, including the work of the EMA;
- present significant national activities regarding the 3Rs for regulatory testing of medicinal products for human and veterinary use;
- encourage open discussion on the 3Rs in regulatory drug testing with stakeholders such as the pharmaceutical industry, NGOs, method developers, researchers, etc.
Program (to be confirmed)
9.00 AM – Opening and Welcome
- Hugues Malonne, CEO, Federal Agency for Medicines and Health Products (FAMHP)
- Selected policy makers
9.30 AM – Contribution of the FAMHP to the 3Rs for regulatory testing of medicines – Chair: TBA
- Advancing the 3Rs at the EMA: a journey from the Joint Expert Group on 3Rs to the new 3Rs Working Party – Sonja Beken (FAMHP)
- Non-clinical testing of human medicinal products and 3Rs – Non-clinical Working Party activities – Karen Van Malderen (FAMHP)
- The risk-based approach for ATMPs – a new paradigm with 3Rs opportunities – Claire Beuneu (FAMHP)
- Implementing the 3RS in quality Control and batch release testing – view from the Belgian OMCL – Morgane Florens (Sciensano)
- Opportunities for 3Rs implementation in medical device testing – Pieter Van De Vijver (FAMHP)
- Q&A
12.30 PM – Lunch
1.30 PM – Stakeholder initiatives on 3Rs – Chair: TBA
- Industry view: Kirsty Reid (EFPIA)/TBA (AnimalhealthEurope)
- An NGO view: HSI/PETA/CFE
- View from DG RTD / IHI: 3Rs projects for regulatory testing of human medicinal products (Christian Desaintes, EC)
2.30 PM – Panel discussion – fostering the 3Rs – Moderator: TBA
3.45 PM – National 3Rs activities – Chair: Karen Van Malderen
- PARERE network – Birgit Mertens (Sciensano)
- IC-3Rs (Vera Rogiers, IC-3Rs, VUB)
- Re-place (Mieke Van Mulders – Sciensano, VUB)
- Beltox (Steven Van Cruchten – Beltox, UA)
- Round tables on Animal Experimentation / Animal Ethics Committees (Eveline Roose – Dept Environment, Flemish Government)
5.30 PM – Concluding remarks
5.45 PM – Closing of the public conference
Useful information
- Wednesday January 31, 2024 from 9:00 a.m. to 5:45 p.m.
- Registration required via the online form until 19/01/2024.
- Flanders Meeting and Convention Center in Antwerp.
- Conference language: English.
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