Micro-credential (2 ECTS)

Course objectives

• Establish a foundational understanding of the Medical Affairs profession and its role within Biotech, Pharma, and MedTech/Medical Devices organisations.
• Understand the seven pillars of the Medical Affairs Competency Framework: Medical Strategy, Scientific and Technical Knowledge, Medical Governance and Compliance, Business Knowledge, Evidence Generation, Scientific Engagement and Communication, and Leadership Management.
• Understand the Medical Affairs Plan, its structure and strategic value, and how to design a Medical Affairs Strategy in both Pharmaceutical and MedTech settings.
• Explore the role of Medical Affairs as a strategic business partner, including its interplay with Integrated Business Plans, Evidence Generation Plans, and patient engagement in clinical development.
• Understand data generation strategies including Phase 3b/4 studies, registries vs. epidemiological studies, post-hoc analyses, and publication strategies.
• Appreciate the strategic role of Medical Affairs in the context of the new EU MedTech Regulations and quality of care considerations.
• Develop skills in Scientific Engagement and Communication, including the use of scientific platforms and value-creation through publications.
• Apply all competencies through workshops and applied learning exercises covering real-world Medical Affairs scenarios in both Pharma and MedTech settings.

Audience

Professionals from the MedTech and Bio-Pharma industries as well as Clinicians and other Healthcare Professionals interested in understanding the fundamentals of the Medical Affairs profession.

Registration deadline

23 November 2026 (early-bird: 1 November)