GVP Module XVI – Risk minimisation measures (Draft for Public Consultation)
GVP Module XVI – Risk minimisation measures (Draft for Public Consultation)
On 01 Feb 2021, EMA has released draft Regulatory and procedural guideline on “GVP Module XVI – Risk minimisation measures: selection of tools and effectiveness indicators (Rev 3)” for Consultation
The following points included in the Revision 3:
GVP Module XVI – Risk minimisation measures (Draft for Public Consultation)
| Changes to XVI.A. | To clarify the role of risk minimisation for risk management planning and for the impact on the risk-benefit balance of medicinal products, and the role of effectiveness evaluation of risk minimisation measures, and to delete/merge concepts already included in other sections of the Module
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| Addition of XVI.B.2. | To give more guidance about the criteria for applying/requesting additional risk minimisation measures
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| Changes to XVI.B.3.1. | With a new classification for educational materials
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| Changes to XVI.B.3.4. | Regarding the concept of controlled access systems and examples illustrating the requirements
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| Addition of XVI.B.4. | To clarify the role of risk communication, dissemination and implementation as a relevant part of any additional risk minimisation activity
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| Changes to XVI.B.5. | To give more guidance on criteria and methods for risk minimisation evaluation; emphasis has been given on the concept of risk minimisation evaluation, which includes an iterative planned and prospective approach with integrated measurement of different elements and regulatory follow-up;
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| Changes to XVI.B.5.4. | To give more guidance on risk minimisation evaluation parameters (e.g. implementation, behavioural changes, outcomes), including suitable study designs and data collection methods
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| Addition of XVI.B.7. | To provide recommendations on additional risk minimisation measures within the lifecycle of the product
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| Changes to XVI.C.3. | To give more details on the role of healthcare professionals and patients and to clarify possible strategies for their early engagement and role in risk minimisation development, dissemination and evaluation
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| Deletion of Appendix I on survey methodologies and integration of this guidance in Addendum II of this Module.
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