backJoin us for the eleventh CLE webinar in our Fundamentals of EU Pharmaceutical Law series, The Revision of the EU General Pharmaceutical Legislation.
This session will address the latest EU regulatory developments, following the recent conclusion of negotiations on the revision of the EU general pharmaceutical legislation and the publication of new legislative proposals under the EU Health Package. While the revised pharmaceutical framework has not yet been formally adopted or published, the political agreement reached by the EU institutions provides substantial insight in the direction and substance of the revision.
During this webinar, we will discuss what is currently known about the agreed pharmaceutical revision, alongside the proposed EU Biotech Act and the proposed amendments to the Medical Devices and In Vitro Diagnostics Regulations, with a particular focus on how these initiatives interact with and impact pharmaceutical companies. Topics will include regulatory incentives and exclusivities, development and approval timelines, clinical trial reforms, combined product regulation, innovation support mechanisms, and emerging compliance obligations.
We will explore the practical implications of these parallel reforms for pharmaceutical and biotech companies, helping participants understand how the evolving EU regulatory landscape may affect product development strategies, pipeline planning, investment decisions and future market access. As multiple legislative initiatives progress simultaneously, early awareness and strategic anticipation are critical.
For questions or for information about registration, contact Sydney Forte.