What does “great” Medical Affairs look like in 2025? We talk evidence, access, patient voice, and how to work with Commercial without crossing the promotional line. Abdul Hameed Al-Khateeb, Country Medical Director, shares practical lessons on measurement, real-world evidence, and where AI actually helps.

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Definitions of things mentioned in the episode

Medical Affairs Professional Society (MAPS)

Description: A global non-profit organization that provides frameworks, guidance, and educational resources for medical affairs professionals. Their work on measuring the impact of medical affairs is particularly influential.

Link: https://medicalaffairs.org/

International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) Code of Practice

Description: This code sets out a global framework for ethical interactions with healthcare professionals, medical institutions, and patient organizations.

Link: https://www.ifpma.org/resource-centre/ifpma-code-of-practice/

FDA Guidelines on Scientific Exchange

Description: The U.S. Food and Drug Administration (FDA) provides specific guidance on how pharmaceutical companies can engage in truthful, non-promotional scientific exchange with healthcare professionals, particularly concerning unapproved uses of approved products. These are often referenced in industry training and SOPs.

Link (example of related guidance): https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs

International Society for Pharmacoeconomics and Outcomes Research (ISPOR)

Description: A leading professional society for health economics and outcomes research. They have published numerous "Good Practices" reports that guide the design and reporting of real-world evidence (RWE) studies.

Link (to their RWE resources): https://www.ispor.org/strategic-initiatives/real-world-evidence

ICH E6(R2) Good Clinical Practice

Description: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. The ICH E6(R2) guideline for Good Clinical Practice (GCP) is the global standard for designing, conducting, recording, and reporting clinical trials involving human participants.

Link: https://www.ema.europa.eu/en/ich-e6-good-clinical-practice-scientific-guideline

Good Publication Practice (GPP) for Company-Sponsored Biomedical Research: 2022 Update

Description: This guideline provides best practices for the ethical and transparent planning, development, and dissemination of company-sponsored research.

Citation: DeTora, L. M., et al. (2022). Good Publication Practice (GPP) guidelines for company-sponsored biomedical research: 2022 update. Annals of Internal Medicine, 175(11), 1601-1610.

Link: https://www.ismpp.org/gpp-2022

General Data Protection Regulation (GDPR)

Description: A European Union regulation on data protection and privacy for all individuals within the EU

Link: https://gdpr.eu/what-is-gdpr/