A Practical Guide to Writing Risk Management Plans (RMPs)
In the EU, all companies are required to provide risk management plans (RMPs) for every new product, whether generic products or new chemical entities, and these RMPs must also be modified and updated throughout the lifetime of a medicine. This intensive one-day course will provide you with an invaluable overview of writing and maintaining RMPs, with practical advice to ensure you achieve regulatory compliance. You will discuss best practice for using the EU templates and risk minimisation tools to enhance the benefit/risk of your product.
The programme has been fully revised to cover the latest updates and new requirements, including amendments made to the previous template.
Upcoming start dates
Suitability - Who should attend?
Benefits of attending
- Gain an overview of ICH and EU RMPs – their production and ongoing maintenance
- Clarify the documentation to be supplied to regulators and the process for RMPs
- Learn what happened in the EU RMP update and explore the new requirements
- Discuss the EU templates and their completion – generic and innovator products
- Understand the relationship between RMPs, post-authorisation safety and efficacy studies, safety reviews and PBRERs
- Discuss the RMP and risk minimisation follow-up
Request information - obligation free
Customer Outreach Award
We believe that it should be easy for you to find and compare training courses.
Our Customer Outreach Award is presented to trusted providers who are excellent at responding to enquiries, making your search quicker, more efficient and easier, too.
Reviews by course attendees
Average rating 4.6
Experienced and knowledgeable speaker. Answered all questions and presented in a clear and concise manner.
Excellent speaker who managed to keep the listener's attention through a complex document and process. Very useful slides that I will consult when requested assistance with RMP ...
About IPI Academy
International Professional & Industry Academy (IPI) is an international leading professional training organisation based in London. Our training solutions provide a return on your investment with measurable results, and are delivered by experienced professionals and managed with exceptional care and...
Specific, accurate and useful.