Module

Regulation, major laws and compliance

Covers the regulators, quality standards, data laws, and post-launch compliance shaping the sector.

5 lessons • 750 XP available

Lessons

1
The regulatory map: FDA, EMA, and the bodies that police biotech and medtech

Identify the FDA, EMA, and bodies policing the sector.

+150 XP
2
Quality is the law: GMP, GLP, and GCP in practice

Apply GMP, GLP, and GCP quality standards in practice.

+150 XP
3
The EU shake-up: MDR, IVDR, and the CE mark reset

Navigate the EU MDR, IVDR, and CE mark reset.

+150 XP
4
Guarding the data: HIPAA, GDPR, and Part 11 for health data

Protect health data under HIPAA, GDPR, and Part 11.

+150 XP
5
Staying compliant after launch: pharmacovigilance, recalls, and enforcement

Manage pharmacovigilance, recalls, and enforcement after launch.

+150 XP