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A number of trends including tougher regulatory controls, increased transparency expectations, an increasingly vocal patient and greater requirements for post-marketing evidence have driven the growth of medical affairs over the years. This changing landscape is placing new demands on the medical affairs function creating a requirement for clearer process and role definition, increased collaboration with other functions including commercial, clinical and R&D, better understanding of the regulatory and compliance environment, and a more effective way of demonstrating the value of activities.
Defining the desired impact for Medical Affairs, deriving metrics associated with those activities, and developing a format for reporting accomplishments to senior management will be essential to demonstrate value. “Showing the value of medical affairs will be very important in that transformation from support function to a strategic partner”, says Charlotte Kremer, Global President of The Medical Affairs Professional Society (MAPS)™, speaking at their annual meeting in Miami in February.