Module 8: Pharmacovigilance

Abstract

The module Pharmacovigilance covers the activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problems. It provides knowledge on the basis of adverse events, regulations and guidelines, handling safety issues, labeling and risk management systems and processes during the pre- and postmarketing phase of medicinal products.

Objective

Participants will acquire the ability to undertake key activities in the field of pharmacovigilance in the pre-marketing phase as well as over the whole life-cycle of a medicinal product. Participants will know and understand that all pharmacovigilance activities must be carried out in compliance with the requirements of the relevant regulatory authorities. They will know how to collect, handle, assess and report safety information to the relevant stakeholders and how to perform safety reports, risk management plans and risk/benefit assessments. Participants will know how to interact with the relevant departments within the company as well as with health care professionals, regulators, and licensing partners.

Content

1) Introduction to Pharmacovigilance with an overview on relevant definitions, pathomechanisms, incidence, costs and preventability. 2) Collection and handling of safey data in clinical trials and establishing the saftey profile during clinical development 3) Managing safety with marketed medicinal products 4) Causality and correlation in Pharmacovigilance 5) Regulatory and legal framework of Pharmacovigilance 6) Ethical issues

Resources