Track 38: Pharmacovigilance and Drug Safety Monitoring

Overview: Pharmacovigilance and Drug Safety Monitoring

Pharmacovigilance (PV) is the science and set of activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. It plays a vital role in ensuring the safety and efficacy of pharmaceutical products throughout their lifecycle, from pre-marketing trials to post-marketing surveillance.

Key Sub-Topics in Pharmacovigilance and Drug Safety Monitoring:

Adverse Drug Reaction (ADR) Reporting · Risk Management Plans (RMPs) · Signal Detection and Analysis · Post-Marketing Surveillance (PMS) · Individual Case Safety Reports (ICSRs) · Benefit-Risk Assessment · Pharmacovigilance in Clinical Trials · Regulatory Requirements (FDA, EMA, ICH) · Global PV Databases (e.g., VigiBase) · Pharmacogenetics in Drug Safety · Medical Device Vigilance · Real-World Data in PV · Digital Tools for PV · Safety Labeling and Updates · Pharmacovigilance Compliance and Audits