Description
Proactive risk management is a major component of good pharmacovigilance practice (GVP). This course 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. This program is based on a variety of sources, such as CIOMS IX, ICH E2E, EU GVPs, FDA guidance for the industry, and GVP Module V (Rev 2, 2017).






