A Practical Guide to Writing Risk Management Plans (RMPs) Training Course

This course provides a clear, practical, and comprehensive guide to writing, maintaining, and updating Risk Management Plans (RMPs) in line with current EU regulatory requirements. As RMPs are mandatory for all medicines throughout their lifecycle, the ability to produce high-quality, compliant plans is essential for ensuring patient safety and successful regulatory submissions.

Designed to bridge theory and real-world application, the course explores the purpose and structure of RMPs, the global context of risk management expectations, and how EU requirements align with international standards. It provides detailed insight into how RMPs support benefit–risk evaluation, integrate with key regulatory documents, and evolve throughout a product’s lifecycle.

Participants will gain practical guidance on using EU templates effectively, understanding the differences between generic and innovator products, and applying risk minimisation strategies that meet regulatory expectations. The course also highlights how RMPs interact with ongoing pharmacovigilance activities, including safety monitoring, reporting, and post-authorisation studies.

With a strong focus on current regulatory updates and best practice, this training equips attendees with the knowledge and confidence to develop robust, inspection-ready RMPs and to manage them effectively within a dynamic regulatory environment.