Overview of Medical Affairs Flashcards
What is the role of Medical Affairs (MA) in pharma?
MA bridges internal stakeholders (R&D, Commercial) and external stakeholders (HCPs, regulators), ensuring scientific integrity and strategic support across a drug’s lifecycle.
What are the core functions of Medical Affairs?
Medical communication, medical education, clinical trial support, and KOL engagement.
How has Medical Affairs evolved in pharma strategy?
MA is now a strategic partner alongside R&D and Commercial, acting as a facilitator, engagement champion, and empowerment enabler.
Who are Medical Affairs’ internal and external stakeholders?
Internal: R&D, Regulatory, Commercial;
External: HCPs, KOLs, HTA bodies, regulators, patients, guideline bodies.
How does MA contribute to drug launch success?
MA aids clinical development with insights, ensures regulatory readiness, enables scientific sales messaging, supports market access with RWE, and drives patient-centric design.
List five strategic roles of Medical Affairs.
- Scientific accuracy,
- Clinical research support,
- Real-world evidence generation,
- Market access support,
- Patient advocacy.
What trends are influencing Medical Affairs?
Digital transformation, patient-centricity, interdisciplinary collaboration, and growing reliance on RWE.
What are key challenges faced by MA?
RWE acceptance inconsistency, regulatory complexity, need for digital upskilling, balancing science and commercial goals.
What future opportunities exist for Medical Affairs?
Shaping RWE standards, deepening patient engagement, leading innovation, driving digital engagement.
How did UK MA teams address RWE challenges?
Collaborated with ABPI and regulators to standardise RWE, focused on underrepresented populations, aligned data with NHS priorities.
Summarise the multifaceted role of Medical Affairs.
MA acts as a strategic function, regulatory gatekeeper, patient advocate, scientific communicator, and commercial enabler.
