Pharmacovigilance: in layman’s terms is “drug safety”. It can be defined as the study and prevention of adverse effects caused by pharmaceutical products. Pharmacovigilance is the reason that many drugs are withdrawn from or not even brought into the market at times.
Pharmacovigilance course highlights the critical requirement for adverse event reporting when conducting clinical trials, and introduces the operational requirements and regulatory processes involved in the detection, assessment, understanding, and prevention of adverse effects of drugs after they have been licensed for use.
The focus will be on drug safety monitoring, in accordance with national and international legislation and guidelines, as well as proactive strategies for risk management to improve patient safety.
Course participants will gain a firm understanding and international knowledge of the regulatory frameworks and processes that apply to drug safety monitoring over the course of 6 weeks. The course has three modules.
Module 1: This module is aimed at providing participants with an overview of some of the challenges companies faced in implementation of safety standards and best practice in managing their implementation in order to comply with applicable legislation and guidance. This module will cover the development and requirements of Good Pharmacovigilance Practices (GVP) as well as other aspects of the new legislation. This will also cover the recognition and interpretation of adverse drug reactions and their underlying toxopathology and pharmacology.
- Clinical development process
- History and overview of Pharmacovigilance
- PV Scenarios
- Adverse events and its types
- Drug safety in clinical trials, Post marketing trials
- AE reporting – Spontaneous reports
- Different sources of AE reporting
- Different types of AE reporting forms
- Reporting timelines
- Roles of Case recipe unit and triage unit
- Valid criteria for AE reporting
- Seriousness criteria of AE reports
- Listedness of AEs
- Causality assessment of AEs
- Process of duplicate search
- Data entry – 1. Book in 2. Case processing 3. MedDRA / WHODD coding
- SAE Narrative writing
- Case quality check
- Medical review and submission
- PSUR and its submission timelines
- Training on ARGUS database
- Importance of each field in ARGUS
- Processing of AE’s in ARGUS database