- Date: June 26th
- Time: 16:00 – 16:45 CET
The European Union is undertaking a significant overhaul of its pharmaceutical legislation, the first major revision since 2004. The reform aims to enhance the availability, accessibility, and affordability of medicines across the EU, while supporting innovation and addressing public health challenges.
In April 2023, the European Commission proposed a new directive and regulation to replace the existing framework. The European Parliament adopted its position at first reading in April 2024. Currently, the Council of the EU is reviewing the proposals, after which trilogue negotiations will begin. Final adoption is anticipated between late 2026 and early 2028.
Join Ingrid Prieschl, Regulatory Affairs Consultant, for an in-depth analysis of the proposed changes, current legislative status, and potential impact for stakeholders in pharma and biotech.
Here’s what we’ll walk through in the webinar:
- Overview of the legislative revision and current status
- Modulation of incentives, including changes to data and market exclusivity
- Regulatory changes
- Measures to address shortages and ensure security of supply
- Environmental obligations related to pharmaceutical manufacturing and distribution
- Council proposals on tackling antimicrobial resistance
Who should attend?
Whether you are part of a pharmaceutical company, biotech firm, or regulatory body, this session will provide valuable insights into the evolving EU pharmaceutical regulatory landscape.
About the Speaker
Ingrid Prieschl is a Regulatory Affairs Consultant at Zwiers Regulatory Consultancy. With extensive expertise in EU procedures, she supports clients in interpreting and the legislation across the product lifecycle.
