Course Content for Pharmacovigilance Training:

Introduction to clinical research: Fundamentals and basics of Pharmacovigilance

Clinical Trials: Collection of Safety Data and Establishing the Adverse Drug Reaction Profile

Clinical Laboratory Safety Data in Drug Studies

Ethical Issues in Drug Safety

Operational aspects of the drug safety function within a pharmaceutical company

Regulations in pharmacovigilance: FDA, EU, ICH, Global regulations

Introduction to safety databases and different types

Serious Adverse events (SAE) and its types

Different types and sources of Adverse events reporting

Regular and expedited adverse event reporting and its timelines

Interactions with different departments working on pharmacovigilance

Roles and responsibilities of case Intake, Triage, Process, Quality control and Medical Review units

Vital factors for the case deportability for seriousness criteria of adverse event

Expectedness or listedness of serious adverse event

Causality assessment of the serious adverse event

Triage, Process, QC-ing of SAE cases

Regulatory Aspects of Pharmacovigilance

Reporting Forms: Medwatch, CIOMS

Legal Aspects of Pharmacovigilance

Management of initial and follow-up information and documention for individual safety reports.

Safety and clinical database overview and Identifying validity of case and processing

Dictionaries and coding in Pharmacovigilance

MedDRA coding for events and medical history

Product or Drug coding using WHO Drug Dictionary (WHODD)

Exercise for WHODD and MedDRA coding

Event grading using regular/rush cases regular/downgrading of serious adverse events

Consolidating diagnosis or deficient in of effect for event recognition and downgrading adverse events

Identifying multiple suspect products, drug interaction or overdose

Preparation of Line listing for periodic regulatory reporting (PSURs)

SUSAR (serious unexpected suspected adverse reaction) Processing

Reconciliation of serious adverse events

Case quality check, medical review and its submission.

Adverse event case narrative Writing Exercise

Overall workflow of drug safety operations

Managing drug safety issues with Marketed Products

Program Highlights: Detailed lectures, study materials and demonstration of the entire work flow of the Life Cycle Drug Safety for the Drug Safety Professional. Power-Point presentations, hand-outs and books. Real time hands on practice for safety case narrative writing and drug safety data practice.