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What’s happening in Europe in 2025?

Regulators in Europe are going at breakneck speed issuing guidance, adjusting to changes introduced during 2024 and new laws to implement in 2025.

The new European Medicines Agency fees regulation became applicable as of January 1, 2025.
Also, Europe is wrangling with the Windsor Framework that aims to ensure the continued medicines supply to Northern Ireland after Brexit (also effective January 1, 2025). Yes, Brexit is still causing challenges.
The overhaul of European Pharmaceutical legislation is still ongoing and under hot debate. This legislation regulates the approval of medicines at the EU and national levels, handling of medicines shortages, incentives for orphan and pediatric medicines and much more. The presentation will touch on some of the most important legislative and guideline developments throughout 2024 and how they impact pharmaceutical regulation in Europe in 2025.

Speaker: Kirsten Messmer, PhD, RAC
Kirsten Messmer, PhD, RAC is the owner of KM Intel LLC which supports companies with actionable intelligence to inform their policy and regulatory strategy. She was previously a Senior Research Analyst and contributed to the research for AgencyIQ on regulatory issues affecting the bio-/pharmaceutical industry in the US and Europe.
Before that, Kirsten was a Principal Regulatory Affairs Specialist at PPD providing global regulatory intelligence to support efficient, compliant and successful clinical research and drug development for biopharmaceuticals and advanced therapies. Kirsten has held additional positions in university and biotechnology research and has 14+ years’ experience in regulatory affairs with a particular focus on regulatory intelligence.
Kirsten received her PhD in Neuroscience from the University of Sheffield (Sheffield, UK), a Biology Diploma from the Eberhard-Karls University (Tübingen, Germany) and
holds a Regulatory Affairs Certification (RAC) in US regulation.