Netherlands Edition: Discovering The EU’s Updates Regulatory Landscape & Impact

New EU Pharma Legislation, HTA Regulation, Orphan Drug Policy, and CTR Implementation 

Join us for an afternoon of expert-led sessions on the latest EU (bio)pharmaceutical legislation, regulatory frameworks, and firsthand insights from the field. This half-day event is designed for regulatory professionals, market access experts, and decision-makers navigating the shifting landscape of EU pharma and clinical development. 

Event Agenda  

12:00-13:00 – Lunch and Welcome 

13:00-13:10 (10 min) Welcome and introduction of event and speakers 

13:10 – 14:00 (50 min) New EU Pharma Legislation – an overview of the key aspects and status of implementation 

14:00 – 14:50 (50 min) Orphan medicines and Paediatric Investigation Plans. Impact of the New EU Pharma Legislation 

14:50 -15:10 (20 min) Coffee Break 

15:10- 16:00 (50 min) New EU Health Technology Assessment Regulation – an overview of what’s new and status of the implementation 

16:00 – 16:50 (50 min) Clinical Trial Regulation – status and first experiences after 3 years of effect 

16:50 – 17:00 (10 min) Concluding remarks 

17:00 – 17:30 Coffee & Networking 

Who should attend? 

This seminar is relevant for Regulatory Affairs, Market Access & Pricing, Clinical Development, and/or Rare Disease & Paediatric Drug Development professionals working at biotech, pharma companies, or institutes. 

Why join?

By attending, you’ll better understand how recent and upcoming EU regulatory changes may affect drug development and market access. The sessions will provide context to help you interpret these developments and consider their relevance to your work. It’s also an opportunity to connect with peers and exchange perspectives on shared regulatory and operational challenges. 

Registration 

Participation is free, but spaces are limited. Secure your spot today and stay informed on the regulatory changes shaping the EU pharmaceutical landscape! 

Location 

Biotech Training Facility, Sylviusweg 70, 2333 BE Leiden