EUCRAF is pleased to announce the names of the speakers of Seminar 2. This Seminar provides an introduction to the regulatory processes for marketing authorisations, clinical trial authorisations and variations valid in the EU, and other regions including USA, Switzerland, Japan and China.

Dr. Connie van Oers from Xendo together with Dr. Gabriele Dallmann are the Course Leaders of this seminar. Dr. van Oers gives a talk on European National Mutual Recognition (MRP) and Decentralised Procedure (DCP).

Dr. Dave Gilbert from NDA Regulatory Services presents the European Centralised Procedure at the European Medicines Agency (EMA).

Dr. Hartmut Krafft from Paul-Ehrlich-Institut presents the Clinical Trial Application (CTA) in Europe.

Dr. Leyna Mulholland from Roche Pharma/Chugai Pharma speaks on the regulatory procedures relevant for submissions at the FDA and the Japanese Agency.

Dr. Tilo Netzer from Merck Serono presents the PDUFA process at FDA.

Dr. Gabriele Dallmann from EUCRAF speaks on strategic considerations on selecting the authorisation procedure.

Dr. Esther Imboden from Regulix LTD discusses the particulars of regulatory processes in Switzerland.

Dr. Steffen Gross from the Paul-Ehrlich-Institut presents how to submit variation applications and what the critical requirements are for variations valid for biopharmaceuticals in the EU.

Dr. Ruth Rettenmeier from Parexel Drug Development Consulting provides the critical aspects relevant for changes in the Summary of Product Characteristics (SmPC).

Dr. Karen van Graevenitz Buser from Roche gives an insight into the requirements valid for regulatory submissions in China.