Course overview
This course delves into the world of additional Risk Minimisation Measures (aRMMs), providing a thorough understanding of their development, implementation and assessment. Participants will explore the regulatory framework surrounding aRMMs, learn how to design effective risk minimisation strategies and evaluate their impact on patient safety and healthcare outcomes. This course combines theoretical knowledge with practical insights, enabling attendees to enhance their skills in managing and monitoring aRMMs in their organisations.
CPD Hours: 3
Course Content
- Day 1
- Introduction to aRMMs
- Understanding global regulatory guidelines for aRMMs
- Principles of designing risk minimization strategies
- Practical approaches to implementing aRMMs
- Methods for monitoring and assessing the impact of aRMMs
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.
