Course overview
On this course, participants will gain an in-depth understanding of the purposes, regulatory requirements, and practical implementations of both Risk Evaluation and Mitigation Strategies (REMS) and Risk Management Plans (RMP) and their importance on drug safety. The course will highlight key differences and similarities and provide real-world examples to illustrate how each document is applied to the same product.
CPD Hours: 3
Course Content
- Day 1
- Introduction to REMS and RMP
- Regulatory framework
- Components of REMS and RMP
- Developing REMS and RMP
- Implementation and management
- Case study: comparative analysis
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.
