This intensive course explores current opportunities made possible by the legislation, advances in information technology and a 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 (EURMPs).
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.
- 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
- Pharmacovigilance/Drug Safety Professionals
- Regulatory Affairs Professionals
- Quality Assurance Professionals
- Risk Management Professionals
- Patient Safety Professionals
- Lifecycle Management Professionals
- Auditor & Inspector
- Heads of Benefit-risk Management