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.

Featured topics

Approaches for benefit optimisation and risk minimisation of products in the EU
Designing benefit-risk management systems using current regulatory tools, including EU Risk Management Plans (EU-RMPs), Development Safety Update Report (DSUR), Periodic Safety Update Report (PSUR)
Best study designs for safety and efficacy follow-up, and how to measure their effectiveness

What you will learn

Legal possibilities for benefit optimisation and risk minimisation of products in the EU
Designing Benefit-Risk management systems using current regulatory tools, including EU Risk Management Plans (EU-RMPs), Development Safety Update Report (DSUR), Periodic Safety Update Report (PSUR)
Best study designs for safety and efficacy follow-up, and how to measure their effectiveness

Who should attend?

Professionals most likely to benefit from this training have experience in pharmacovigilance, drug safety, regulatory affairs, risk management, medical affairs or similar positions within the pharmaceutical industry. Those in charge of the design and maintenance of risk management systems, pharmacovigilance auditing or inspecting, Qualified Persons for Pharmacovigilance (QPPVs) and heads of benefit-risk management, patient safety, or lifecycle management will learn all the essential aspects needed for successful Benefit-Risk management. Examples are presented for small as well as large organisations.

Learning objectives

At the conclusion of this course, participants will be able to:

Describe benefits, risks and benefit-risk profiles of drugs
Plan safety and efficacy follow-up systems, including the best choice of study designs and available registries
Optimise benefits and minimise risks of products, including the best use of an evidencebased toolbox
Communicate benefit-risk profiles to key stakeholders (regulators, healthcare professionals,...)
Measure effectiveness of the planned actions – both risk minimisation and benefit optimisation.

Participants will complete a knowledge check at the end of the course and will be provided with feedback to ensure learning objectives are attained.

Plan Your Team's Professional Development

Why not take advantage and train your whole department (or even across different departments!) and benefit from increased:

Focus
Flexibility
Convenience
Cost Effectiveness

For more information please contact Basel@DIAglobal.org

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Benefit-Risk Management