Would you like to know what is and what are the objectives of Risk Management Plan? If so, please join this course. The objective of this course is to perform introduction training to Risk Management Plan by getting the objectives and the key concepts of the GVP Module V.
The aim of a risk management plan (RMP) is to document the risk management system considered necessary to identify, characterise and minimise a medicinal product’s important risks. To this end, the RMP contains:
- The identification or characterisation of the safety profile of the medicinal product, with emphasis on important identified and important potential risks and missing information, and also on which safety concerns need to be managed proactively or further studied (the ‘safety specification’)
- The planning of pharmacovigilance activities to characterise and quantify clinically relevant risks, and to identify new adverse reactions (the ‘pharmacovigilance plan’)
- The planning and implementation of risk minimisation measures, including the evaluation of the effectiveness of these activities (the ‘risk minimisation plan’)
As knowledge regarding a medicinal product’s safety profile increases over time, so will the risk management plan change.
Would you like to know more? Join the course!
After course completion, student:
- Demonstrates knowledge and understanding of key RMP concepts, principles, methods and tools
- Demonstrates knowledge of key regulations and guidelines related to RMP (incl. GVP module V)
- Can explain the roles and responsibilities of the different bodies involved in the preparation, submission, maintenance, update and evaluation of RMP
- Has a basic theoretical knowledge of RMP
- Can explain the purpose and scope of the RMP
- Understands the main concepts of planning the product risk management process, including risk minimization activities
- Can assess which data are important for the preparation of RMP
- Understands the structure of the RMP and is comfortable using it to identify relevant Information
