Opening Joint Plenary Session: Thought Leader Discussion Panel – Regulatory Challenges
Panelists: Gert Bos, Qserve, Bassil Akra, TÜV SÜD Product Service GmbH, Oliver Bisazza, MedTech, Sabina L. Hoekstra-van den Bosch, Central Committee for Research Involving Human Subject (CCMO), Graeme Tunbridge, Medicines & Healthcare Products Regulatory Agency, Valerie Nys, Federal Agency of Medicines and Health Products (FAMHP) and EMA, EU Competent Authority and European Commission invited, Erik Hansson, European Commission.
New medical devices regulations (MDR, IVDR) and other regulatory developments in Europe significantly impact EU market access for device, IVD, combination product and pharmaceutical products. Hear the latest critical insights from prominent thought leaders and influencers; authorities, regulators and industry representatives will highlight what’s high on their radar and action lists. Concise summary presentations from experts followed by interactive panel with audience participation to guide understanding of the requirements and discuss implementation challenges.