backJoin us for the next CLE webinar in our Fundamentals of EU Pharmaceutical Law series, focusing on how AI is reshaping the pharmaceutical sector — from internal efficiency gains to emerging digital health tools. With the EU AI Act now in force and EMA guidance evolving, companies face a complex regulatory environment that raises questions about whether Europe’s approach supports innovation or adds significant compliance burdens.
We will cover the AI Act’s risk‑based classification system, the R&D exemption and the provider/deployer distinction, as well as the overlapping obligations created when the AI Act, MDR, CTR and EMA expectations apply simultaneously. The session will also touch on links with the GDPR, the proposed European Biotech Act, the European Health Data Space Regulation and EMA‑FDA guiding principles, and will conclude with practical governance recommendations for AI inventories, cross‑functional oversight, generative AI policies and engagement with regulators.
For questions, or for information about registration, contact Ella Peek.