Ethics and compliance are fundamental to pharmaceutical operations, ensuring transparency, accountability, and adherence to global regulatory standards. Medical Affairs serves as a key pillar in maintaining ethical integrity across scientific communication, data privacy, and interactions with healthcare professionals (HCPs). Regulatory frameworks such as the Sunshine Act, EFPIA, and GDPR govern financial disclosures, promotional activities, and patient data protection. Ethical considerations extend to clinical trial transparency, responsible marketing, and the prevention of conflicts of interest. As digital health and AI transform medical affairs, emerging challenges in data security, algorithmic bias, and informed consent require continued vigilance and ethical oversight.

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Ethics and Compliance: The Leading Role of Medical Affairs

  • Andriy Krendyukov

摘要

Ethics and compliance are fundamental to pharmaceutical operations, ensuring transparency, accountability, and adherence to global regulatory standards. Medical Affairs serves as a key pillar in maintaining ethical integrity across scientific communication, data privacy, and interactions with healthcare professionals (HCPs). Regulatory frameworks such as the Sunshine Act, EFPIA, and GDPR govern financial disclosures, promotional activities, and patient data protection. Ethical considerations extend to clinical trial transparency, responsible marketing, and the prevention of conflicts of interest. As digital health and AI transform medical affairs, emerging challenges in data security, algorithmic bias, and informed consent require continued vigilance and ethical oversight.