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Medical Affairs Services Conjoining Providers and Consumers by Quality Driven Management

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Today,  the  excellence   of  compliance  in  pharmaceutical marketing/business has  become  an   important issue reflecting  significant  changes  in  the  regulatory   environment  across the world.  Pharmaceutical  companies  should  conduct  promotional activities, but it should be  within  the  limit  of  corporate  policies as well as governmental  approvals. False and fabricated or any misleading promotion are rigorously prohibited everywhere. Medical Affairs services are normally involved in content approval of any promotional material under the guidance and supervision of expert personnel.  Marketing content development team is trained to avoid improper and non-scientific promotional activities. The  promotional  review  committee  has  to  be  update   with  the  latest rules  of promotion,  which also include  false and fabricated promotion  or  misleading  promotion.  Such expertise in most cases is ensured by Medical Affairs department.

Medical Affairs services are now taking a more prominent role in the development and commercialization of medicines, as an internal/external support to the commercial organisations.  Traditionally, activities such as copy review, sales force training and issue management were the core activities. While these activities are still important, Medical affairs services is taking on a much broader remit in the development and commercialisation of drugs. Providing development with insights on real world experience of a drug or disease, generation and dissemination of data and partnering with commercial and market access on strategic commercialisation issues are increasingly important elements of Medical Affairs services. In addition, there is an increased emphasis on external interactions of Medical Affairs services which has now gone beyond patients and practitioners.
In defining the key business questions for Medical Affairs, the first step is to map how the strategic goals of the organization translate into actionable objectives .Thus, Medical Affairs services approach is to identify a handful of objectives as specifically as possible, and then to identify and track the underlying critical success factors (CSFs). Once the CSFs are agreed, associated key performance indicators (KPIs) are proposed. While there is a necessary upfront investment of time and effort in order to define qualitative metrics, such approach of Medical Affairs services push the organization to identify and focus on factors which are likely to be the best surrogate indicators of future success.
Medical Affairs Management services maintain the ICH-GCP compliance and provide the quality clinical data by ensuring the adherence to SOPs and GCP under ICH recommendation guidelines.  Generally, Pharmaceutical companies have two types of scientific teams: one for Medical Affairs services and another for research and development. Research and development describes the scientific method and initial stage development, as well as includes clinical trial runs, whereas Medical Affairs services provide scientific support for later stage development and post marketing support. Besides marketing, Medical Affairs services function is to deliver technical backing to both internal teams as well as external customers. It also includes field-based medical information specialists who provide in-depth drug and disease information to health providers. Thus, Medical Affairs services deliver information services to instruct department personnel and to ensure that consumer queries are adequately addressed, as well as distribute data to health care providers in the community. Medical Affairs teams also frame publications plans and report important trial results to the Pharmaceuticals and medical devices agency (PMDA), in scientific meetings or by providing journal articles etc.
Thus Medical Affairs is an important function which is required to qualitatively manage information transfer between healthcare industry, healthcare professionals and patients,

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