Risk Management Planning for Medicinal Products
Instructor
Syed Salman
Reviews
Course Overview
Proactive risk management is a major component of good pharmacovigilance practice. This module sets out the principles of risk management planning and outlines regulatory requirements for risk management plans in regions that are major markets for medicinal products.
Learning objectives
- Explain important principles of risk management planning.
- Give examples of risk minimisation activities.
- Describe the selection of risk minimisation activities that are proportional to a product’s benefit/risk balance and do not impose undue burden on stakeholders.
- Outline regulatory requirements for risk management plans in regions that are major markets for medicinal products.
What You'll Learn?
- All staff working in medical, drug safety, or pharmacovigilance departments of pharmaceutical or biotechnology companies or contract research organisations should have access to this module. It will also be of value to healthcare professionals and regulatory authority personnel.