Certification Course in Pharmacovigilance (Recorded)

Self-paced recorded programme  Lifetime access

Self-paced recorded programme. After payment you will receive the access link on the thank-you page and in your email.

Syllabus

1) Overview Clinical research and History and development of PV
2) Basics of Bioequivalence, Bioavailability, Pharmacodynamics and pharmacokinetics.
3) Adverse Drug Reactions, Key Terminologies in PV, Methodologies in Pharmacovigilance
4) Clinical trials-Types, Phases
5) ICSR management and case studies
6) MedDRA coding
7) Seriousness and causality assessment
8) Narrative writing
9) Safety database overview- example- Argus, Aware, Aris g etc.
10) Special scenario in PV
11) Signal detection and management
12) Overview of Periodic Safety Update Reports (PSURs), Aggregate reporting, medical writing, Importance of local literature search
13) MICC (Medical information contact center) overview
14) Pharmacovigilance System Master File (PSMF), Risk Management Planning (RMP), Reference Safety Information (RSI)
15) PV inspection and Audits
16) Contract research organization (CRO)
17) Pharmacovigilance Regulations in Various Countries

Benefits

• Learn at your own pace
• Same core PV syllabus as the live batch
• Certification Provided
• Study Material Provided