Stay up to date with the latest changes in pharmacovigilance guidance. This course provides a focused overview of key updates introduced in GVP Module XVI (Rev 3) and Addendum II, covering the latest regulatory expectations, best practices in designing and implementing risk minimisation measures, and implications for MAHs. Ideal for pharmacovigilance professionals looking to ensure compliance and enhance the effectiveness of RMMs in the EU.
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Key updates on GVP Module XVI Risk minimisation measures (Rev 3) and Module XVI Addendum II
About course
This course includes
63 minutes of Video Content
60 minutes of Additional Learning Materials
Competence Test with 27 questions
Certificate after course completion
COURSE INSTRUCTOR
By attending this course, you will learn
- Explain the key updates introduced in GVP Module XVI Revision 3 and Addendum II and their implications for risk minimisation strategies
- Describe new terminology and classification of RMM
- Identify the regulatory expectations for designing, implementing, and evaluating additional risk minimisation measures (aRMMs) under the updated guidance
- Design effective implementation pathways and dissemination plans for additional risk minimisation measures, ensuring alignment with regulatory requirements and best practices
- Apply principles of effectiveness evaluation to assess the impact and success of RMMs in line with revised GVP guidance
- Evaluate the role of patient and healthcare professional involvement in the implementation and optimisation of aRMMs, including communication strategies and engagement methods
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