The course covers information on additional risk minimization (aRMM) as an integral part of the Risk Management Plan. Thanks to this course, you will learn about Management of the process of planning, preparation, writing, review, quality control, distribution and evaluation of the effectiveness of the aRMM. I will draw attention to important issues such as roles and responsibilities of the different stakeholders involved in the implementation of the aRMM. You will become acquainted with adjustment of risk minimisation activities proportionate to the impact on patient safety of the identified risks and managing the process of developing the first aRMM. You will discover management of the process for updating the ARMM. What’ s more, you will get to know about process of evaluating the effectiveness of the activities carried out in the form of the aRMM and examples of process and outcome indicators.
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Additional risk minimization measures
Language: English 🇬🇧
Total Duration: 97 minutes
69.00€
By attending this course, you will learn
- Basic information on Additional Risk Minimisation Measures
- How to distinguish routine and additional risk minimisation measures
- What are main concepts of managing the process of minimising the risk of a medicinal product, purpose and scope
- What are key aRMM concepts, principles, methods and tools
- What are key regulations and guidelines for aRMMs
- What are the reference documents and sources of information about aRMMs
- Specific examples of activities aimed at minimising the risk
- Roles and responsibilities of the different stakeholders involved in the implementation of the aRMM
- How to adjust the risk minimisation activities proportionate to the impact on patient safety of the identified risks
- How to manage the process of developing the first aRMM (format, layout, content, key elements and basic wording used within the aRMM)
- How to manage the process of updating the ARMM
- How to manage the process of evaluating the effectiveness of the activities carried out in the form of the aRMM
- What are examples of process and outcome indicators
- How to manage the process of planning, preparation, writing, review, quality control, distribution and evaluation of the effectiveness of the aRMM
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