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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
Senior Regulatory Expert, Federal Institute For Drugs and Medical Devices (bfarm), Germany
Translation of Basic Research into Product Development
Christoph Conrad
, Paul-Ehrlich-Institut, Germany
Regulatory Expertise through Research - The PEI Model
Klaus Cichutek, PhD
Director, Paul-Ehrlich-Institut, Germany
Faster Access to Innovations - Where to Go?
Karl Broich, DrMed
President, Federal Institute for Drugs and Medical Devices (BfArM), Germany
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