Jörg PlesslDirector EU Affiliates, Regulatory Affairs at Norgine
Jörg has worked in a variety of roles in Regulatory Affairs for the past eighteen years with a focus on European pharma and medtech legislation. In his current position as the Director Affiliate Regulatory Affairs for Norgine, a leading independent European specialist pharma company, he is involved in the life cycle management of the existing portfolio as well as the development of new medicinal products and medical devices for Europe. He is the co-chair of the Substance Medical Devices Working Group of the German Pharmaceutical Industry Association (BPI) and of the Regulatory Affairs Working Group of the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE). Furthermore, he also represents EUCOPE in the MDCG Borderline and ClassificationWorking Group (B&C) as well as in different stakeholder meetings with European regulatory authorities and institutions, such as the European Medicines Agency (EMA), the Co-ordination Group for Mutual Recognition and Decentralised procedures - Human (CMDh) and the European Directorate for the Quality of Medicines & HealthCare (EDQM).