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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.

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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Contact us

For additional event or venue information, please email fei.xie@diaglobal.orgYou can also reach us at +86 01057042659