The Avanzado level of the Aleph Regulation of Pharmaceuticals & Dispositivos Médicos 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 Curso de Certificación Profesional builds directly on the 16-hour Introductorio level (`RAQ-510-I`). It does not repeat the orientation material. Where the Introductorio level identifies IND and IDE, the Avanzado level constructs a clinical-investigation plan under each. Where the Introductorio level identifies MAUDE and FAERS, the Avanzado 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 Avanzado course are positioned for applied work in cross-categorical Asuntos Regulatorios 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.

Los participantes que cumplan los requisitos de finalización del curso reciben un Certificado de Finalización emitido por Aleph University.