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 course will provide an invaluable overview of writing and maintaining RMPs, with practical advice to ensure you achieve regulatory compliance. The programme has been fully revised to include the latest updates.
By attending this course you will:
- Gain an overview of ICH and EU RMPs – their production and maintenance
- Clarify the documentation to be supplied to regulators and the process for RMPs
- Discuss the EU templates and their completion – generic and innovator products
- Understand the relationship between RMPs and safety reviews; PBRERs/DSURs; licence submissions