The course covers detailed information on Risk Management Plan (RMP). Thanks to this course, you will gain advanced abilities on RMP taking into account various nuances, you will know how to develop, evaluate and implement RMP rules, how create, submit and update RMPs. Moreover, you will discover how to select risks and where we can find them and how to create a strategy for implementing, supervising and managing RMP-related tasks within the organization. Furthermore, you will be able to compare of Periodic Safety Update Report (PSUR) and Risk Managament Plan (RMP). And finally you will get familiar with key regulations, directives, guidelines and recommendations regarding risk management plan.
Our products
Management of Risk Management Plan
Language: English 🇬🇧
Total Duration: 151 minutes
69.00€
By attending this course, you will learn
- Advanced information on RMP taking into account various nuances
- How to develop, evaluate and implement RMP rules, methods and tools
- What are reference documents and source of information used for RMP preparation
- How to perform appropriate selection of risks (Safety Concerns)
- What are the situations where additional risk minimization activities are required
- How to select appropriate risk minimization measures which are commensurate with the benefit-risk balance of the product
- What are the types of RMP’s templates
- How to manage the detailed process of planning, preparation, writing, reviewing, quality control, signing and distribution of the common EU RMP
- How to manage the process of developing the first RMP (format, content, key elements and basic wording used within the document)
- How to present the patient's post-authorization exposure
- How to compare of Periodic Safety Update Report (PSUR) and Risk Management Plan (RMP)
- How to manage of RMP approval process
- How to manage of RMP update process
- How process of review, quality control, finalization and distribution of the RMP look like
- What are the actions to be performed after the approval of the RMP
- How to create, update and improve processes and procedures to ensure the highest possible quality and compliance of RMP-related tasks within the organization
- How to create a strategy for implementing, supervising and managing RMP-related tasks within the organization
No reviews yet
