Regulatory Affairs: Pharma & Diagnostics




Time Wednesday, July 2, 2014: 1st Congress Day

11:25

From Directive to Regulation – Changes of the European Regulation on In Vitro Diagnostic Medical Devices

Dr. Dieter Schönwald, Manager In Vitro Diagnostics
TÜV SÜD Product Service GmbH, Munich

Presentation for members and participants only (PDF 0,4 MB) - in German
Congress TV - in German

11:50

The EU Regulation for Clinical Trials - what's the News?

Prof. Dr. Joerg Hasford, Chairman
Arbeitskreis Medizinischer Ethik-Kommissionen in der Bundesrepublik Deutschland e.V., Munich

Presentation for members and participants only (PDF 0,9 MB) - in German
Congress TV - in German

12:15

Swim with the Sharks – Risk Management Throughout the Life Cycle of a Medicinal Product

Dr. Susanne Kienzle-Horn, Senior Consultant
SCRATCH Pharmacovigilance GmbH, Butzbach

Presentation for members and participants only (PDF 0,9 MB) - in German
Congress TV - in German
12:40 Lunch Break at the Exhibition - Poster Session
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