A department within pharmaceutical, biotechnology, or medical device companies responsible for managing scientific and medical information and providing support to healthcare professionals, regulatory agencies, and internal stakeholders. Medical Affairs plays a crucial role in ensuring the safe and effective use of products.
Professionals within Medical Affairs responsible for building and maintaining relationships with key opinion leaders (KOLs) in the medical community, providing scientific and clinical information about products, and gathering insights from healthcare providers.
A branch of Medical Affairs focused on evaluating the economic and clinical outcomes of healthcare interventions to inform decision-making by healthcare providers, payers, and policymakers.
The provision of accurate, unbiased, and up-to-date scientific and clinical information about products to healthcare professionals, patients, and other stakeholders. Medical Information specialists within Medical Affairs are responsible for responding to inquiries and ensuring compliance with regulations.
A function within Medical Affairs responsible for ensuring compliance with regulatory requirements and obtaining approvals for the development, marketing, and post-marketing activities of products from regulatory agencies such as the FDA and EMA.
The process of designing, conducting, and analyzing clinical trials to evaluate the safety and efficacy of investigational products. Medical Affairs often collaborates with clinical development teams to design studies and interpret data.
The monitoring and reporting of adverse events and other safety-related information associated with the use of pharmaceutical products. Medical Affairs plays a role in assessing and communicating safety information to healthcare professionals and regulatory agencies.
Activities aimed at providing healthcare professionals with knowledge and skills related to the use of products, disease management, and advancements in medical science. Medical Affairs may organize educational events, develop educational materials, and support continuing medical education initiatives.
The strategic planning and execution of scientific publications to disseminate clinical trial results and other scientific findings in peer-reviewed journals and scientific conferences. Medical Affairs oversees publication planning to ensure transparency and compliance with ethical standards.
Forums organized by Medical Affairs to gather insights from KOLs and other experts on various aspects of product development, clinical practice, and healthcare trends. Advisory boards provide valuable guidance for decision-making and strategy development within pharmaceutical and medical device companies.