This course is based on 21 CFR guidelines, designed to provide participants with an in-depth understanding of pharmacovigilance activities and how they are integrated into the drug development process. The topics covered include pharmacovigilance audits (RBI, PLA), risk management (REMS, CAPA, RMP, SMP), signal detection (AERS, VRMPT, RMP, SMP, SPE, PSR, etc), and product safety reviews (PSR, PSUR) based on GVP guidelines. In addition, you will also get a 30 hours hand on training on PvEdge software.
Upon finishing this course, you will be able to:
- Demonstrate an understanding of pharmacovigilance activities and their role in the drug development process.
- Understand how to conduct a pharmacovigilance audit.
- Understand how to manage risk in pharmacovigilance.
- Demonstrate an understanding of signal detection in pharmacovigilance.
- Demonstrate an understanding of product safety reviews in pharmacovigilance.
- Understand how to use PvEdge software for pharmacovigilance activities.
Who Should Attend
This course is required for pharmacovigilance, regulatory affairs, and drug safety professionals. It’s also useful for those looking to enter the field of pharmacovigilance. Students (B. Pharma/ M. Pharma/ B.Sc./M.Sc., MBBS / BDS), pharmaceutical and healthcare industry regulators, and academic research centers)