Program Scope

This training program provides a comprehensive and detailed understanding of global regulatory requirements for pharmacovigilance, including adverse event reporting, signal detection, risk management, and periodic safety reporting. The program integrates requirements from major regulatory bodies, including the FDA (21 CFR Parts 312 and 314), ICH guidelines (E2A, E2B(R3), E2C(R2), E2D(R1), E2E, E2F), EU GVP modules, Canadian GVP guidelines, and MedDRA coding standards. This program emphasizes practical application through detailed case studies.

Learning Objectives

Upon successful completion of this program, participants will be able to:

• Define and differentiate between adverse events, adverse drug reactions, serious adverse events, and unexpected adverse reactions.
• Apply the rules for expedited (7-day and 15-day) reporting of individual case safety reports (ICSRs).
• Prepare and submit periodic safety reports including PSURs, PBRERs, and DSURs.
• Perform signal detection and risk management planning using ICH E2E principles.
• Code adverse events using MedDRA and apply Standardised MedDRA Queries (SMQs).
• Establish a compliant pharmacovigilance system including written procedures, training, and recordkeeping.

Target Audience

• Pharmacovigilance and Drug Safety Professionals
• Clinical Research Associates and Clinical Trial Monitors
• Regulatory Affairs Specialists
• Quality Assurance Personnel in Pharmaceutical Companies
• Medical Affairs Professionals
• Contract Research Organization (CRO) Staff
• Marketing Authorization Holders (MAHs) and their representatives

Certification

Participants will be awarded a Certificate of Completion for the “Global Pharmacovigilance and Safety Reporting Mastery Program” after successfully passing all module-level assessments with a score of 80% or higher. This certification demonstrates a practitioner-level understanding of global pharmacovigilance requirements, ICSR processing, periodic reporting, and signal management.