Medical affairs physicians are the link between the research and development phases of a medicine and its post-licensing launch onto the market, monitoring its safe and effective use by patients. Their role involves:
- conducting market support studies
- providing medical input to marketing strategy
- reviewing drug advertising and the safety (pharmacovigilance) of marketed drugs
- ensuring that the information materials for both prescribers and patients are as accurate and easy to understand as possible.
Medical affairs physicians normally work with a wide spectrum of people both inside and outside the company. They also support the medical liaison team – field-based medical information specialists – who provide in-depth drug and disease information to healthcare providers.
Scientists and physicians working in medical affairs generally act as disease experts within their company. Activities range from:
- educating department members
- seeing that consumer questions are addressed
- providing information services to healthcare providers in the community.
These physicians also work at the interface with clinical healthcare professionals and professional organisations, providing information and other support to people who are recognised experts in their fields, either directly or at conferences etc, and disease and patient advocacy groups.
Medical affairs physicians may also be involved in many aspects of the service of developing, advising on or approving the form and packaging of medicines to ensure that they are made available to prescribers and patients in the correct form and dosage, with appropriate packaging and labelling to enable safe and effective prescribing and dispensing. This work may include:
- special labelling such as braille
- developing adherence aids such as calendar packs or boxes, or electronic reminders and counters, to encourage the timely and correct administration of the medicine
- the development of childproof packaging.
In other situations pharmaceutical physicians are directly responsible for making medicines available when they are otherwise unlicensed, for instance in particular patient use (named patient) programmes, or for continuation therapy with a medicine following a clinical trial, in which it might have demonstrated benefit, but before it is officially licensed.