Module

Regulation, major laws and compliance

5 lessons • 750 XP available

Lessons

1
The regulatory map: FDA, EMA, and the bodies that police biotech and medtech
+150 XP
2
Quality is the law: GMP, GLP, and GCP in practice
+150 XP
3
The EU shake-up: MDR, IVDR, and the CE mark reset
+150 XP
4
Guarding the data: HIPAA, GDPR, and Part 11 for health data
+150 XP
5
Staying compliant after launch: pharmacovigilance, recalls, and enforcement
+150 XP