Pharmacovigilance

Abstract

The course in Pharmacovigilance (PV) provides basic knowledge and solid practical foundations for those who are seeking to work in PV and it will benefit those who are starting their career in other areas in the pharmaceutical industry. The course covers the principles of PV, its regulations, the principles of risk management, Quality Management, and inspections by Health Authorities.

Objective

Students - have a profound understanding of the importance of Pharmacovigilance and can explain the basic principles. - can define the relevant terms used in Pharmacovigilance. - know how to comply with the regulatory requirements. - can describe the requirements for safety reporting. - can show the different phases of the Signal Management process. - can demonstrate the relevance of a Quality Management System. - can describe the principles of Phamacovigilance Inspections. - are able to identify Adverse Effects associated with a drug and can demonstrate the necessary actions.

Content

- General introduction, terms and definitions of Pharmacovigilance - Regulatory environment: Legal requirements (with main focus on the EU and Switzerland). - Reporting requirements in clinical trials. - Reporting requirements post‐marketing. - Aggregate Reports: PSUR / PBRER; DSUR. - Risk Management Plan (RMP). - Signal Detection and Management. - Risk Communication (e.g., Dear Doctor Letter). - Quality Management System: SOPs and KPI’s. - Pharmacovigilance Inspections. - Audits. - Corrective and Preventive Actions (CAPA).

Resources