Course overview
Medical information is an important and key element of drug safety. This programme has been designed for individuals and teams that answer medical enquiries as part of their daily work, as well as new medical information specialists who are starting a career in medical information. The course will go through some important basic aspects and explain the legal requirements for a Marketing Authorisation Holder (MAH) to offer a medical information service in Europe. It will give practical information on how to provide an efficient medical service with linkage to other areas such as marketing, regulatory and drug safety. This programme provides essential guidance on various aspects of the important role of medical information.
CPD Hours: 6
Course Content
- Day 1
- An introduction to the role of medical information
- Medical information service
- Medical information allied services
- Medical information and advertising
- Medical information and safety
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.
