Regulatory affairs connects medical-product innovation with market access and patient safety. Every company in medical devices, pharmaceuticals, biologics, food, or cosmetics operates within a national and international regulatory framework and depends on professionals who understand it fluently.

This introductory course builds the foundation: the U.S. FDA and its centers under the Federal Food, Drug, and Cosmetic Act; the European framework (EMA, EU MDR, EU IVDR); the main submission pathways for devices (510(k), De Novo, PMA, HDE, IDE) and pharmaceuticals (IND, NDA, ANDA, BLA); the ICH and IMDRF harmonization disciplines; quality frameworks (ISO 13485, ICH Q10) and risk management (ISO 14971, ICH Q9); labeling, advertising, and promotion; and other major markets (Canada, Japan, China).

Format: a weekly live session (~120 minutes) with recordings and self-directed materials between sessions. Assessments include a regulatory glossary, a comparative brief, a midterm, and a regulatory-strategy outline as the capstone.

Note: the curriculum may be subject to change.

• Professionals transitioning into regulatory affairs from engineering, clinical sciences, law, quality, or pharmacy.
• Early-career professionals at FDA-regulated companies (devices, pharmaceuticals, food, cosmetics).
• Recent graduates of biomedical engineering, pharmacy, biology, or related science programs.
• Clinical professionals (nurses, physicians, clinical scientists) moving into regulated-industry roles.

No prior experience is required. This is an introductory course designed for professionals coming from other disciplines who want to enter the field. A general interest in medical products, healthcare, or regulated industries is helpful but not necessary.