Basics of Pharmacovigilance in Clinical Trials
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- Organiser: CTC Resourcing Solutions / CTC Clinical Trial Consulting AG
- Name: Tamara Kohler
- Email: firstname.lastname@example.org
This workshop is designed to provide a solid foundation of Pharmacovigilance (PV) in Clinical Trials. It will introduce the most important terms and definitions, MedDRA (Medical Dictionary for Regulatory Activities) coding, SAE (Serious Adverse Event) management, unblinding processes, SUSAR (Suspected Unexpected Serious Adverse Reaction) submission, and a first glance at a PV database.