RAQ 500 — Introduction to Regulatory Affairs - Demo
RAQ 500 — Introduction to Regulatory Affairs
The gateway course of the M.Sc. in Regulatory Affairs and Quality Assurance in Medical Technologies · 2 credits · 10 weeks · online (synchronous + asynchronous) · graduate entry level · no prerequisites.
RAQ 500 surveys the regulatory world: the agencies and their authority, the submission pathways for devices and drugs, and the quality and risk frameworks beneath them — the FDA and its authority under the Federal Food, Drug, and Cosmetic Act; the European framework (EMA, EU MDR, EU IVDR); device pathways (510(k), De Novo, PMA, HDE, IDE) and drug/biologics pathways (IND, NDA, ANDA, BLA); quality systems (ISO 13485, FDA QMSR, ICH Q10); risk management (ISO 14971, ICH Q9(R1)); labeling and promotion; and international harmonization (IMDRF, ICH). It assumes no prior regulatory experience and is built around reading and citing real regulatory sources.
Assessment overview
| Component | Weight | Due |
|---|---|---|
| Regulatory-vocabulary glossary | 15% | Week 9 |
| Comparative pathway brief (FDA vs EU MDR) | 25% | Week 6 |
| Mid-term examination (Weeks 1–5) | 20% | Week 5 |
| Final capstone regulatory-strategy outline | 30% | Week 10 |
| Seminar participation | 10% | Weekly |
Grading scale: A 90–100, B 80–89, C 70–79, F below 70.