Catalog

Medical product regulatory affairs : pharmaceuticals, diagnostics, medical devices

  • Tobi, John J. , Walsh, Gary
  • Wiley-Blackwell
  • 2008
Medical product regulatory affairs : pharmaceuticals, diagnostics, medical devices

Holdings Summary

소장정보
No. Location Call No. Availability Due Date Request/Reservation
1 연세의학도서관/3층 구관/07서가 2열 344.0416 T629m 대출가능 -

Table of Content

1. The Aims and Structure of Regulations
2. Regulatory Strategy
3. Drug Discovery and Development
4. Non-Clinical Studies
5. Clinical Trials
6. Marketing Authorisation
7. Authorisation of Veterinary Medicines
8. Variations to the Drug Authorisation Process
9. Medical Devices
10. Authorisation of Medical Devices
11. Good Manufacturing Practice (GMP)
12. Oversight and Vigilance