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SESSION 14: DRUG SAFETY
Session Chair(s)
Paivi Itkonen
Managing Director
Crown CRO Oy, Finland
Angelika Karwoth
Senior Clinical Research Consultant
Angelika Karwoth Gmbh, Germany
- Definitions and Regulations
- Responsibilities - Sponsor and Investigator
- Processing SUSARs
- Periodic Reporting
- Responsibilities - Independent Ethics Committees and Competent Authorities
Speaker(s)
DRUG SAFETY
Paivi Itkonen
Crown CRO Oy, Finland
Managing Director
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