Evidence Generation Standards & Guidance and Templates
Objectives:
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.
