The European Biotech Act & its impact on clinical trials

The European Biotech Act marks a significant new chapter for biopharmaceutical innovation in Europe. In our webinar, we will provide a concise overview of the Commission’s proposal and its expected impact on clinical trials under the CTR. The session will cover shorter approval timelines for multinational and ATMP studies, a stronger role for the reporting Member State, and new simplifications for decentralized, minimal-intervention, and combined drug-device trials. We will also highlight the increasing role of digitalization and AI in clinical research regulation. Join us for practical insights into what these developments mean for sponsors across Europe.