EUCRAF is pleased to announce the names of the speakers of Seminar 8. This seminar provides scientific advice, regulatory strategy, health technology assessment.

Dr. Stephane Andre from Roche is the Course Leader of Seminar 8.

Dr. Jaques Mascaro from Elan gives a talk on regulatory strategy.

Dr. Thomas Ecker from EPC Healthcare GmbH talks on HTA as a new element of the regulatory strategy - national requirements and European initiatives, reimbursement in Europe and considerations on how to design clinical development programmes to be used for approval and HTA.

Dr. Gabriele Dallmann from EUCRAF speaks on strategic considerations on interactions with regulatory agencies.

Dr. Jan Müller Berghaus from PEI gives a talk on interactions with regulatory agencies in the EU to receive scientific advice. Further he gives an insight into scientific advice from national competent authorities. Together with Dr. Stephane Andre from Roche he holds an interactive tandem session on the interactions of companies (represented by Dr. Stephanen Andre) and agencies (represented by Dr. Jan Müller-Berghaus) in the development of biopharmaceuticals.

Dr. Michelle Jessen from Micromet US speaks on interactions with FDA in the pre-IND process.

Dr. Boris Kreye from Bird & Bird talks on Pharmaceutical Intellectual Property (IP) strategy and practical considerations related to application and maintenance of patents in the EU.

Dr. Heike Wachenhausen from Lützeler Klümper Wachenhausen lawyers, formerly Novartis gives an insight into regulatory protection of medicinal products.

Dr. Susanne Heiland-Kunath from Takeda speaks on a cross-functional strategic forum to support decision-making for regulatory processes.

Dr. Michael Soldan from Biotest AG gives a talk on regulatory strategy for the introduction of changes in the manufacturing process.