What does medical affairs involve? The research and development of a single new medicine can take 10-12 years, with costs running into the billions, and the journey from laboratory to clinic being broken down into several phases of clinical trial. Phase III clinical trials are further along this development process, and, for a successful medicine, lead up to the medicine receiving Marketing Authorisation, or Product License, which allows it to be released onto the market.
Medical affairs physicians, within a pharmaceutical company or contract research organisation (CRO), work mainly with licenced products and those in the pre-licence period. They are involved in phase IV clinical trials, which can be conducted in large numbers of patients, and are designed to further characterise the efficacy and safety of the new medicine. Phase IV studies may be conducted in a formal clinical research setting or may be conducted to provide real-world data. As part of their role, medical affairs physicians work cross-functionally with many other teams to ensure that the information about the safety and efficacy of the medicine is continuously being gathered and updated.
Another main role of the medical affairs physician is in providing commercial support of the new medicine. This involves working alongside external bodies, such as regulatory authorities, and various departments within their company, from Research and Development (R&D) groups, to regulatory affairs, pharmacovigilance, compliance and marketing and sales. Working particularly closely with marketing and sales, the physician must recognise the commercial needs of the organisation, and work to meet those needs, whilst complying with ethical and legal requirements, and industry codes of conduct (e.g. the ABPI Code of Practice).
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Why is it important to industry?
The medical affairs physician essentially ensures patient health and well-being are at the forefront of marketing decisions. This requires providing a clinical interpretation of the scientific and clinical trial data arising from the development process, which can be understood by the various stakeholders in the marketing decisions for the new medicine. This then ensures the promotional materials used in the marketing of a licensed medicine are medically accurate, and in compliance with the Product License, ethical and legal requirements, and industry codes of practice. Therefore, it can be said that the physician responsible for this role can have more influence over the use of the new medicine than an individual prescribing doctor.
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Qualifications and training A pharmaceutical physician wishing to move into medical affairs must have an interest in the commercial aspect of the pharmaceutical industry, balanced with a strong sense of ethics and the ability to work in a team with people from a variety of different backgrounds.
When a physician enters the pharmaceutical industry, it is recommended they undertake further education and training in the specialty of pharmaceutical medicine. Entry to this requires a specific amount of time to be spent in clinical practice, which is usually completed before moving into industry and physicians are advised to check the requirements carefully when considering a move into the industry. Further education and training in the specialty of pharmaceutical medicine is achieved through the 4-year Pharmaceutical Medicine Specialty Training programme (PMST), which includes the Diploma in Pharmaceutical Medicine (DPM) from the Faculty of Pharmaceutical Medicine, and provides a route to obtaining a Certificate of Completion of Training (CCT). A GMC license is a requirement for pharmaceutical physicians, and also for completion of the PMST. Being licensed with the GMC means that, upon completing the PMST programme and obtaining a CCT, the physician can gain entry to the GMC's Specialist Register in Pharmaceutical Medicine. For more information on the PMST, please visit the Faculty of Pharmaceutical Medicine's booklet.
A physician in medical affairs will need to have a thorough knowledge of the ABPI Code of Practice, and to maintain this through professional development the PMCPA offer training. Depending on the role, a medical affairs physician may also need to certify their knowledge of the ABPI Code of Practice through completing the ABPI exam, and for more information on this please see the link to the left of this page.
For more information regarding medical affairs careers, and additional pharmaceutical careers for physicians, please see the "Articles of Interest" box to the right of this page.
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I work with medics, pharmacists and scientists to ensure the safe promotion of medicines and to run clinical studies.