Course overview
In the EU, all companies are required to provide Risk Management Plans (RMPs) for every new product, including both generic medicines and new chemical entities, and to maintain and update these plans throughout the entire lifecycle of a medicine.
This intensive one-day course delivers a clear, practical, and comprehensive overview of how to write, maintain, and update RMPs, equipping you with expert guidance and real-world insights to help you achieve and maintain full regulatory compliance with confidence.
You will gain practical, actionable advice on best practice for using EU templates and risk minimisation tools, enabling you to strengthen benefit-risk profiles and enhance regulatory submissions. Through expert-led discussion, you will build a robust understanding of how to apply regulatory expectations effectively in your daily work.
The course reflects the latest regulatory updates and new requirements, including amendments made to the previous template - ensuring the content is fully current, relevant, and immediately applicable.
CPD Hours: 6
Course Content
- Day 1
- Introduction, welcome and objectives
- An introduction to RMPs
- Outline of EU RMPs
- The EU templates and their completion - generic and innovator products
- Completion of RMPs in other countries
- The EU RMP and relationship with other documents
- The RMP and Risk Minimisation Follow up
- Overview of the sections of the EU RMP template
- Final discussion session
Speakers
Graeme Ladds
Graeme Ladds, Director of PharSafer, has over 30 years’ experience in the pharmaceutical industry. He began his career in 1989 at Ashbourne Pharmaceuticals as Head of Drug Safety & Medical Information, before going on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals.
He later founded his consultancy and specialist CRO, PharSafer Associates Ltd, where he has supported companies in establishing pharmacovigilance systems, conducting audits across Europe and the USA, developing SOPs, acting as a QP, and supporting regulatory inspections.
Since 1994, Graeme has also been involved in the monitoring of medical devices, including drug-device combinations, structural devices and electrical medical devices. His experience spans clinical trials and global device vigilance, alongside pharmacovigilance activities across both clinical development and post-marketing phases.
