DRUG SAFETY PHYSICIAN COURSE PHARMACOVIGILANCE

This comprehensive program equips participants with the knowledge and skills required to assess, manage, and report adverse drug reactions (ADRs), ensuring patient safety and regulatory compliance.

Learning Objectives:

✔ Understand the fundamentals of pharmacovigilance and its role in healthcare.

✔ Identify and assess adverse drug reactions (ADRs).

✔ Analyze safety signals and benefit-risk assessments.

✔ Prepare and review individual case safety reports (ICSRs).

✔ Comprehend regulatory requirements for drug safety across global agencies (FDA, EMA, MHRA, etc.).

✔ Develop risk management plans (RMPs) and periodic safety update reports (PSURs).

✔ Collaborate with cross-functional teams in clinical trials and post-marketing surveillance.

Course Curriculum:

✅ Introduction to Drug Safety & Pharmacovigilance

✅ Regulatory Framework & Compliance (ICH-GCP, FDA, EMA, WHO, etc.) ✅ Case Processing & Individual Case Safety Reports (ICSRs)

✅ Signal Detection & Risk Management Strategies

✅ Periodic Safety Update Reports (PSURs) & Risk Evaluation Mitigation Strategies (REMS)

✅ Medical Assessment of Adverse Events & Causality Assessment

✅ Drug Safety in Clinical Trials vs. Post-Marketing Surveillance

✅ Pharmacovigilance Systems & Databases (MedDRA, EudraVigilance, Argus, etc.)

✅ Medical Writing & Safety Narrative Writing

✅ Career Opportunities & Industry Insights Mode of Delivery: • Online & Classroom Training Options • Live Instructor-Led Sessions & Self-Paced Modules