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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.
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.
Key Topics
- 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
Target Audience
- 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
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