Fri 16 Oct 2015 @ 10:00
Zenosis, the leading provider of eLearning for the medicinal products industry, has announced the release of a new course: PV05: Risk Management Planning for Medicinal Products.
Proactive risk management is a major component of good pharmacovigilance practice. 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.
All staff working in medical, drug safety, or pharmacovigilance departments of pharmaceutical or biotechnology companies or contract research organisations should have access to this course. It will also be of value to healthcare professionals and regulatory authority personnel.
In the first session, the modern emphasis on proactive risk management in addition to routine pharmacovigilance measures is discussed. Risk assessment factors important in safety specification, pharmacovigilance planning, and risk minimisation for a drug are described. The selection, implementation, and evaluation of non-routine risk minimisation activities is the focus of the rest of the session.
The second session outlines regulatory requirements for risk management plans in Europe, the USA, and (in a brief sketch) Japan. The structure, main components, and submission requirements for EU Risk Management Plans and US Risk Evaluation and Mitigation Strategies are described, and notable aspects of risk management requirements in Japan are identified.