SUNDAY, JANUARY 27 | 9:00AM-5:00PM
This full-day short course will focus on basic aspects of the product lifecycle regulatory framework for pharmacovigilance in the context of risk management planning. The practical aspects of managing biopharmaceutical product risks will be emphasized in the context of benefits and the healthcare delivery system. The main discussion will be devoted to the EU and US situations, but this will be supplemented with experience gained in other selected jurisdictions. Q&A will be encouraged.
*Short Courses are not included in the meeting registration and require a separate fee.
- Discuss similarities and differences in risk management planning in the three ICH regions and other selected jurisdictions
- Describe the differences between important identified risks and important potential risks
- Outline the basic structure and contents of an EU Risk Management Plan (in the context of a Risk Management System) and a Risk Evaluation and Mitigation Strategy (REMS)
- Discuss primary and non-routine tools for managing product risks, how the effectiveness of a selected tool is assessed, and points to consider for the modification, revision, or release of a given non-routine intervention