This intensive course explores current opportunities made possible by the legislation, advances in information technology and new scientific methodology to enhance and modernise the approaches in the product lifecycle management.
The course starts with the current regulatory thinking about the Benefit-Risk methodology, including the relevant projects of the European Medicines Agency (EMA) / Committee for Medicinal Products for Human Use (CHMP). It gives a basis for the second part of the course, exploring the new European Benefit-Risk management planning – a notion stemming from the experience gathered over the past ten years with the EU Risk Management Plans (EU-RMPs). Participants will learn how to take advantage of the efficacy follow-up options given by the EU law and guidelines. A practical training in solving key aspects of the Benefit-Risk management based on real-life examples is included.
Participants will be provided with preparatory material in order to better participate at the group exercises onsite.
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, quality assurance, 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.
At the conclusion of this course, participants will be able to:
Describe safety, efficacy, and effectiveness 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 evidence-based toolbox
Present the Benefit-Risk documents to regulatory authorities and health technology assessment bodies
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:
- Cost Effectiveness
For more information please contact EMEA@DIAglobal.org