Building on the Annex XIV and CEP foundation of the Introductory level, this Advanced course develops the investigation, reporting and follow-up disciplines that keep clinical evidence alive across the device life cycle.

This 32-hour Professional Certificate Course covers the clinical-investigation plan and protocol aligned with ICH GCP E6(R3) and ISO 14155:2020, informed consent, the structure and content of the Clinical Study Report under ICH E3, and post-market clinical follow-up (PMCF) requirements under EU MDR.

By the end, participants can produce an ICH E3-aligned CSR excerpt, build a PMCF plan element and complete a Clinical Evaluation Plan outline for a chosen device.

The Advanced course connects the investigation protocol, the CSR and PMCF into a complete clinical-evaluation lifecycle, preparing participants for clinical-affairs and clinical-evaluation authoring roles.

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