Pharmacovigilance with Internship
Online certification with internship & dual certification (AI + PV)
Course fee
₹8,999.00
Secure online enrollment · Installments on select courses
Why choose this course
Syllabus
Overview Clinical research and History and development of PV
Basics of Bioequivalence, Bioavailability, Pharmacodynamics and pharmacokinetics
Adverse Drug Reactions, Key Terminologies in PV, Methodologies in Pharmacovigilance
Clinical trials — Types, Phases
ICSR management and case studies
MedDRA coding
Seriousness and causality assessment
Narrative writing
Safety database overview — Argus, Aware, ArisG, etc.
Special scenario in PV
Signal detection and management
Overview of PSURs, Aggregate reporting, medical writing, local literature search
MICC (Medical information contact center) overview
PSMF, Risk Management Planning (RMP), Reference Safety Information (RSI)
PV inspection and Audits
Contract research organization (CRO)
Pharmacovigilance Regulations in Various Countries