The Medical Affairs Professional Society (MAPS) Insights Focus Area Working Group (FAWG) formed a subcommittee to identify best practices and recommend guidelines for an effective insights management process. The following slides are an overview of key success factors identified.
Over the last decade as the requirements for evidence to support the various dimensions of value assessment of medicines have strengthened and the breadth of audiences has increased, Medical Affairs is realizing more potential and bringing together its capabilities for strategy, science, and communication in powerful ways. In the rapidly evolving regulatory, technological, and scientific environment, the Medical Affairs function is uniquely positioned to coordinate the identification, prioritization, strategic planning, execution and communication of the broad variety of high-quality evidence necessary to fulfill unmet needs of clinicians, payers, reimbursement agencies, policy makers, advocacy groups, and patients.
This Standard and Guidance is intended to inform learners about the Evidence Generation function, strategic direction, and operations across multiple geographies.
Medical Information is a critical conduit with healthcare providers who interact with field sales or scientific professionals or who seek scientific information independently. In this customer-facing and customer-focused capacity, Medical Information is the “face” of the manufacturer to many external customers and serves to facilitate the safe and effective use of the marketed products. Medical Information has a significant role in supporting the information needs of HCPs, patients, and caregivers through the provision of medical information in response to unsolicited questions about the manufacturer’s products and strives to provide excellent customer service based on the customer’s expectations through a variety of channels. MedInfo also partners with internal business functions, including, but not limited to: Medical Affairs, Pharmaceutical and Clinical Development, Quality Assurance, Manufacturing, Publication Planning, Safety, Business Technology, Finance, Legal, Regulatory, and Commercial/Marketing.
This Standard and Guidance is intended to inform learners about the Medical Information (MI) function, strategic direction, and operations across multiple geographies.
Standards and Guidance powerpoint and templates for Medical Affairs strategic planning
External Education is the provision of diverse learning opportunities to facilitate knowledge exchange, learning, and skills acquisition through funding of independent medical education (accredited or non-accredited), industry-led medical education, or collaborations addressing knowledge, competence, and performance gaps for HCPs, payers, and patients/caregivers. However, External Education has long been without a standardized language and practice. It is with this background in mind that the MAPS External Education Focus Area Working Group (FAWG) developed the comprehensive Standards & Guidance resource available to MAPS members here.
Where Medical Affairs may have served in a scientific support role in years past, now it is one of the key drivers of all efforts, positioned at the nexus of Regulatory, Clinical, Market Access, and Commercial needs, as a bridge to all and as a strategic partner with Commercial. This has occurred in large part because the days of successfully launching a new product based solely on making it available through regulatory approval and marketing efforts no longer exists. Use the MAPS Launch Excellence Standards & Guidance plus templates to guide your launch planning process in this new Medical Affairs landscape.
The Medical Affairs teams demonstrate leadership and value each year through the annual strategic planning process that aligns all multifunctional MA competencies on common objectives needed to support the product and organization. A focused and cohesive medical strategy must be developed to navigate the complex therapeutic environment for each product – overcoming challenges, taking advantage of opportunities and filling any scientific or clinical gaps. A comprehensive and supportive tactical plan aligned to the medical strategy should define the activities that will provide the most impact and benefit to stakeholders in therapeutic space while taking the MA team one-step closer to achieving annual goals.
The MAPS Medical Affairs Strategic Planning Guide and Template has been developed to provide guidance and recommendations to selected components that comprise the strategic medical affairs planning for a product – including the situational analysis, medical strategy, tactical/operational planning, and medical plan summary.