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Medical Affairs

Similar or Alternative Terms Meaning the Same Thing n/a
Related Term(s) Medical-Legal Review (MLR), Medical Science Liaison (MSL), Compliance

Definitions

Most pharmaceutical companies have two kinds of scientific teams: research / development and medical affairs. While R & D defines the scientific direction and early stage development, medical affairs provides scientific support for late stage development and post market support for drugs and devices.

Medical affairs usually functions alongside marketing, to provide technical support to both internal teams and external customers. So what kinds of tasks are involved?

1. Informational services - the scientists and physicians working in medical affairs generally act as disease experts. Activities range from educating department members, seeing that consumer questions are addressed, and providing informational services to health care providers in the community. Medical affairs also formulates publications plans, and the reporting of pivotal trial results to the FDA, at scientific meetings and through journal articles.

2. Regulatory review - medical affairs works with regulatory affairs and the legal department to insure that all written documents are accurate and adhere to the guidelines mandated by the FDA. All educational, technical and promotion materials are reviewed.

3. Liaison to health care professionals and professional organizations, and disease state advocacy groups. Medical affairs works to support the efforts of professional associations, patient support groups, and educational foundations.

4. Thought leader development -- this involves providing information and other supports to persons who are recognized experts in their fields.

5. Educational meeting support -- in the "olden" days, pharmaceutical companies actually wrote, staffed and sponsored continuing medical education events. Educational meeting support now only can be provided in the form of unrestricted educational grants.

6. Supporting marketing -- medical affairs provides the scientific input and expertise in the design and construction of all promotional materials and events. At the least, materials are reviewed by medical affairs for scientific accuracy. Medical affairs officers may also present relevant scientific information at marketing functions.

7. R & D -- depending on the structure of a company, medical affairs may also be responsible for all stages of clinical development including study design, initiation and monitoring. Medical affairs also may oversee the dispersal of funds and /or study drugs for investigator initiated trials.

8. Post market drug safety functions - in some companies medical affairs handles drug safety, reviewing individual adverse event reports, aggregate adverse event statistics, and sometimes even talking with customers about drug safety. (In some firms, these tasks fall under the egis of regulatory affairs).

9. Medical liaison - many companies have teams of medical liaison reps (MLRs) who are often field based medical information specialists, providing in depth drug and disease state information to health providers in their territories. They function as colleagues and experts in their fields. (Note that some companies may employ medical sales liaisons (MSLs) who, while providing services like MLSs, work within the marketing department)

Source: Just what do you do: medical affairs job description

Article: PhRMA Code Helps Re-define Roles of Medical Affairs and Marketing.

Articles: MSLs and KOL Management.


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