Pharmaceutical products and medical devices share regulatory objectives (protecting the patient, requiring evidence of safety and effectiveness) but operate under distinct legal, scientific, and submission frameworks. Regulatory Affairs professionals who work across the full health-product ecosystem — at companies producing combination products, at organizations with both drug and device portfolios, or in cross-jurisdictional strategy — need to command both frameworks in parallel. This is increasingly true in the post-pandemic era, with the proliferation of combination products, digital health products, and cell-and-gene therapies that cross traditional boundaries.

This 16-hour Professional Certificate Course is the entry point of the Aleph Regulation of Pharmaceuticals & Medical Devices course track. It introduces the FDA framework (FFDCA and the applicable CFR parts), the EMA framework (EU MDR, EU IVDR, EU pharmaceutical regulation), and the principal pathways across both worlds: pharmaceutical development (preclinical, clinical phases, NDA/BLA) and medical-device development (Design Controls, 510(k), De Novo, PMA). It also orients participants to clinical-investigation regulation (IND, IDE, ICH GCP), adverse-event reporting (FAERS for pharmaceuticals, MAUDE for devices), and the combination-product framework managed by the FDA Office of Combination Products.

The course prepares participants for the Advanced level (`RAQ-510-A`), where the same content is exercised at applied depth — comparative drug-versus-device analysis, applied ICH GCP planning, applied EU MDR / IVDR work, applied adverse-event reporting, applied combination-product analysis, and a cross-categorical strategy memo. Together the Introductory and Advanced levels form a 48-hour course track.

The Introductory course establishes the cross-categorical vocabulary the regulated industries expect of someone working across both pharmaceuticals and devices. Employers in this space include integrated health-product manufacturers, combination-product companies, contract research organizations, pharmacovigilance specialists, and regulatory consultancies that serve cross-category clients.

Participants who meet the course completion requirements receive a Certificate of Completion issued by Aleph University.