The Advanced level of the Aleph Regulation of Pharmaceuticals & Medical Devices course track is for professionals who already know both regulatory worlds at orientation depth and need to develop the applied skills that cross-categorical RA work demands: planning a clinical investigation under ICH GCP and the applicable U.S. clinical-investigation regulations; applying the EU MDR and EU IVDR to a device submission and the EU centralised pharmaceutical procedure to a drug submission; analyzing a combination product under the FDA Office of Combination Products framework with Primary Mode of Action determination; conducting applied analysis on the MAUDE and FAERS adverse-event databases; and authoring a cross-categorical strategy memo that handles a real product spanning drugs and devices.

This 32-hour Professional Certificate Course builds directly on the 16-hour Introductory level (`RAQ-510-I`). It does not repeat the orientation material. Where the Introductory level identifies IND and IDE, the Advanced level constructs a clinical-investigation plan under each. Where the Introductory level identifies MAUDE and FAERS, the Advanced level conducts hands-on queries against both. The course culminates in a cross-categorical regulatory analysis course exercise — a portfolio-grade artifact in which the participant chooses a product (typically a combination product), constructs a parallel FDA and EMA strategy, and lays out the clinical-evidence plan that satisfies both jurisdictions.

Graduates of the Advanced course are positioned for applied work in cross-categorical Regulatory Affairs roles at integrated health-product manufacturers, at combination-product companies, at contract research organizations, in pharmacovigilance and post-market surveillance specialists, and at consultancies serving cross-categorical clients. The cross-categorical strategy memo produced during the course is a portfolio-grade artifact that demonstrates the participant’s ability to think strategically across drug and device worlds and across FDA and EU jurisdictions.

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