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. It 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.
Benefits in attending
- Understand the role of medical information
- Know the legal requirements for a Medical Information Service
- Discuss standard responses, FAQs and complex questions
- Clarify the guidelines for medical information and advertising
- Receive practical advice on Black Triangle Products and additional monitoring
Certification:
- CPD: 6 hours for your records
- Certificate of completion
Agenda
An Introduction to the role of medical information
- The legislation requiring an MAH to offer a Medical Service
- The education and training of the Medical Services team
- Availability of the Medical Service
Medical information service
- Standard responses
- Frequently Asked Questions (FAQs)
- Company internal information
- Complex questions
Medical information allied services
- Medical information and ADRs
- Medical information and product quality
- Competitor analyses
- Routine literature searching
Medical information and advertising
- What is a promotional item?
- Longevity of promotional items
- Off label usage
- Product Claims
Medical information and safety
- Black Triangle products and additional monitoring
- Patient and Health Care Practitioner (HCP) education programmes
- Safety and special situations
- Understandable Information
- Education and product risk minimisation
Speakers
Mr Graeme Ladds,
Director ,
PharSafer Associates Ltd.Graeme Ladds, Director of PharSafer, has over 22 years’ experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, Graeme went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals.
The last 11 years have been spent in his consultancy company, PharSafer Associates Ltd. During this time, Graeme has been involved in establishing pharmacovigilance in companies, performing audits across Europe and the USA, SOP writing, acting as QP for companies, and helping with regulatory inspections.
Who Should Attend
- Personnel whose role includes answering medical enquiries
- New medical information specialists
- Regulatory affairs
- Drug safety, especially those who have a dual drug safety/medical information role
- Marketing personnel involved in promotional sign-off, product launches
