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role of medical affairs in pharmaceutical companies ppt

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You can change your ad preferences anytime. We have noticed this from time to time in our surveys that many Big Pharma Companies have considered Medical Affairs importance seriously and have now implemented a well-planned strategy to recruit, engage and manage their medical affairs team effectively. Medical Affairs The Role of a Medical Advisor... A Pharmaceutical Physician working in medical affairs will have a hugely varied role. Because Medical Affairs works closely with both scientific and commercial leaders within a pharma company, the function may be positioned under either Global Commercial or Global Development. The FDA mandates that pharmaceutical companies have an adverse event tracking mechanism for their products. Within individual markets, such as the US, Medical Affairs is sometimes organized by business unit, brand, or therapeutic area, so that the range of Medical Affairs services can be tailored to the complexity of the product and disease state. Medical affairs services play critical role between a pharmaceutical company and external stakeholders. PRINCETON PHARMA COMPLIANCE CONFERENCE; Michael Edwin Kafrissen, MD, MSPH. Physicians working for smaller biotech companies, which often employ 50–100 people and focus on one or two disease areas, might have to fulfill multiple roles of R&D, medical affairs, and pharmacovigilance simultaneously. Drug and Biological Development: Springer US; 2007. p. 240-74. Medical Affairs is both a rewarding and challenging area in the evolving environment of drug development and launch readiness planning. Medical Affairs is the majority of credible link with external stakeholders and also play a progressively more important role in communicating the product or service value message to physicians in an objective and ethical manner. Synthesizing all available research and health economics data, Medical Affairs provides Brand teams with insights about their products. It’s critical to note, however, that Medical Affairs has no control over the actual content of the program. Regulatory Affairs also has a very specific meaning within the healthcare industries (pharmaceuticals, medical devices, Biologics and functional foods). Finally, Medical Affairs contributes valuable market intelligence. Medical Communications may also be part of a promotional review committee, helping the Legal, Regulatory, and Compliance teams verify the accuracy of the clinical messages developed by the Brand team. The breadth and complexity of the role could be one reason why we are seeing more outsourcing of medical affairs by pharmaceutical companies. Amazon recently announced that it is entering the healthcare business, looking to control costs but also to empower the consumer. Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Who are the customers? 2001;35(2):547-55. Title: The Role of Medical Affairs in Shaping Brand Development 1 The Role of Medical Affairs in Shaping Brand Development. Over many years, pressure from regulatory agencies, payers and healthcare professionals, as well as public sentiment, has led to a clearer separation between the Medical and Commercial functions. But the fact is that pharma and the companies who support it will need to invest even more in MA to keep up with the rapidly evolving interactions among stakeholders in a notoriously complex industry. Recently, their role has expanded to include health economics and outcomes research (HEOR) and pharmacovigilance. For information on how to enter visit:, PharmaTimes Media Ltd. Medical affairs professionals within the pharmaceutical industry, given their scientific background and training, have the ability and distinct opportunity to help fill this information gap and establish themselves with their “physician base” as a trusted source for scientifically sound medical communications. Medical affairs (MA) will be the single most powerful force in helping pharma do just that. 1,671 Medical Affairs Manager Pharmaceutical jobs available on Even when Medical Affairs is, as shown, situated within the Global Development hierarchy, its activities often come out of the Marketing budget. Thus Medical Affairs … Now, MA departments typically report to C-level staff and have budgets and teams of their own. All indications suggest a fundamental long-term shift in the drug development and commercialisation pathway. Against this backdrop, McKinsey interviewed 20 medical leaders to gain insights into the evolving role of medical affairs within APAC (see sidebar “Who we interviewed”). Protections are usually in place, however, to ensure that Marketing does not impose its commercial perspective on the way those dollars are spent—particularly in regard to external educational programs. In some companies, publication planning is a more strategic undertaking, with greater emphasis on defining the data needed to make the publications effort effective. For decades the medical affairs role was defined primarily by information support and the management of routine regulatory reporting requirements. Although the precise way in which Medical Affairs defines its areas of specialization varies, for our purposes it is useful to arrange them in three broad groupings: Medical Services, Medical Research, and Medical Liaisons. These stakeholders include medical communities, medical societies, payers, regulatory authorities and patient advocacy groups, to name a few. Medical Affairs plays two key roles. The role of patients will also fundamentally change with the rise of consumerism in healthcare. In 2002, the Pharmaceutical Research and Manu- facturers of America (PhRMA), a pharmaceutical industry trade group, published its voluntarily enforced Code on Interactions with Healthcare Profes-sionals that was to be a guideline on ethical practices. Welcome to the Understanding Pharma Series Course on Medical Affairs. Bob Muratore is principal at RPM ConsultingThis year PharmaTimes has launched the new Medical & Scientific Excellence Awards, desinged to challenge, recognise and reward professionals within medical science liaison, medical information and medical / scientific advisory roles. Because the call center mechanism is often used, people sometimes use the term “call center” as shorthand for the medical information function. Medical Affairs is a global function. MEDICAL AFFAIRSTHE UNDERSTANDING PHARMA SERIES Copyright © 2007. All of these characteristics are likely … Medical Affairs professionals will continue to be a vital source of information for physicians looking to improve the health outcomes of their patients. Interactions between pharmaceutical companies and various medical stakeholders will continue to evolve with the emergence of new decision makers and with greater public scrutiny of these relationships. They provide assistance in dissemination of technological information regarding current products to regulating agencies and healthcare professionals. Mansard House In such organizations, each brand frequently has its own Medical Affairs Medical Director—an eminent physician—who is aligned with the Brand Director from Marketing. We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. The role of Medical Affairs is typically most expansive in companies with one or more of the following characteristics: They treat complex disease states. The common objective of all pharmaceutical companies is to discover, develop and market safe, efficacious and cost-effective medicines that will bring benefits to patients, health care professionals and consumers and result in profitable returns to the company. There is no real equivalent to medical affairs in biotechnology, yet it plays an ever-increasing and important role in that industry as well. This led to a series of interventions by Health and Human Services, Office of Inspector General and the Food and Drug Administration. Now customize the name of a clipboard to store your clips. They produce highly innovative products addressing a previously unmet need. Medical affairs has transformed over the past decade, evolving from a supportive role into a strategic decision-maker and trusted scientific partner. Outcome-based models are changing the way business is done. See our User Agreement and Privacy Policy. Its activities, however, can span from the period preceding product launch throughout the remainder of the product life cycle. Evens R. Medical Affairs and Professional Services. Most remain focused on products instead of outcomes, and they regard medical affairs staff as technical product advisers. What publications are ideal? When should publications and press releases be scheduled? The basic functions of each group will be familiar to you from the previous sections of this module: Medical Services has a number of important responsibilities: The medical information center provides a venue for healthcare practitioners (and, to a lesser extent, consumers) to raise product concerns and seek information regarding product use. Proposed medical affairs departmental structure for small organization. Their Medical Writing team may also assist with the development of Meeting presentation materials, such as slide sets Posters—that is, oversized summaries of preliminary trial results, which key opinion leaders may present at medical conferences and in other settings, in what are known as “poster sessions.” Abstracts—summaries of published journal articles. Medical Affairs plays a vital role in launch and promotion of pharma products. See our Privacy Policy and User Agreement for details.

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