A Practical Guide to Writing Risk Management Plans (RMPs)

Course Overview

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.

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

Who Should Attend?

This course will be relevant for those working in pharmacovigilance who are involved with writing RMPs, including medical directors/QPPVs who approve such plans. It will also be of interest to those who work with pharmacovigilance, eg in regulatory affairs, clinical, pre-clinical, sales and marketing, legal, commercial and quality.