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RAI Center

Mar 04, 2013 9:00 AM - Mar 04, 2013 12:30 PM

Europaplein, 1078 GZ Amsterdam, Netherlands

Tutorial 10: Non-Clinical Safety Assessment in Global Pharmaceutical Development

Speakers

Gerd  Bode, MD, PhD

Gerd Bode, MD, PhD

University of Goettingen, Honorable Member of the Medical Faculty, Department of Pharmacology Toxicology , Germany

Gerd Bode holds board certified specializations in Pathology, Neuropathology, Legal Medicine, Pharmacology and Toxicology. He works now as a lecturer and independent consultant in Toxicology and Pathology. Gerd was long term ICH Topic Leader for Safety Guidelines.

Klaus  Olejniczak, DVM

Klaus Olejniczak, DVM

, Non-Clinical Regulatory Consultant, Germany

Klaus Olejniczak is head for the “Geno – and Reproductive Toxicity” Unit in the German Federal Institute for Drugs and Medical Devices (BfArM). At ICH, he serves as EU Topic Leader for several topics (e.g. Safety Pharmacology, CTD – Safety, and Non-clinical Anticancer Drug Development).

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