Course overview
This course provides an essential overview of medical device clinical evaluations, clinical investigations and PMCF studies with particular emphasis on the adverse event reporting requirements during these studies.
Concentrating mostly on the new Medical Device Regulations (MDR) with some references to the existing Medical Device Directives, there will also be a review of the post Brexit implications for device management in the EU & UK.
CPD Hours: 12
Course Content
- Day 1
- Clinical evaluation - an overview
- Clinical investigations - an overview
- PMS and PMCF
- Quiz on clinical evaluation, clinical investigation and PMCF
- New requirements of the MDR
- The competent authority and the Notified Body
- Workshop on the new requirements of the MDR
- Day 2
- Vigilance reporting
- How to define and classify adverse events
- Vigilance workshop
- The regulatory requirements for monitoring and reporting adverse events during regulatory and PMCF studies
- The MDR - clinical elements
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.
