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German Satellite Session - Regulatory and Scientific Contributions of BfArM and PEI to Pharmaceutical Innovation
Session Chair(s)
Karl Broich, DrMed
President
Federal Institute for Drugs and Medical Devices (BfArM), Germany
Klaus Cichutek, PHD
Director
Paul-Ehrlich-Institut, Germany
Providing patients with safe and effective medicinal products in a timely manner is the main expectation society has of medicines agencies and this is also what defines their mission. The German licensing agencies, BfArM and PEI, operate monitoring systems to continuously assure the safety of medicinal products on the market. They proactively support new developments by giving early scientific advice, supporting the approval of clinical trials and combining research and regulation.
Speaker(s)
The New Directive and Current Trends in Clinical Trials
Thomas Sudhop, DrMed
Federal Institute For Drugs and Medical Devices (bfarm), Germany
Senior Regulatory Expert
Translation of Basic Research into Product Development
Christoph Conrad
Paul-Ehrlich-Institut, Germany
Regulatory Expertise through Research - The PEI Model
Klaus Cichutek, PHD
Paul-Ehrlich-Institut, Germany
Director
Faster Access to Innovations - Where to Go?
Karl Broich, DrMed
Federal Institute for Drugs and Medical Devices (BfArM), Germany
President