Overview
This intensive course explores current opportunities made possible by legislation, advances in information technology and new scientific methodologies to enhance and modernise approaches for benefit-risk management in the product lifecycle.
The course starts with key concepts and current regulatory thinking about benefit-risk methodologies, including relevant projects of the European Medicines Agency (EMA) / Committee for Medicinal Products for Human Use (CHMP). It provides a basis for the second part of the course, exploring benefit-risk management planning - a notion stemming from the experience gathered over the past 15 years, e.g. with EU Risk Management Plans (EURMPs).
Participants will learn how to develop optimal safety and efficacy follow-up options consistent with regulatory guidelines. A practical training in solving key aspects of benefitrisk management based on real-life examples is included.
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