Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application).
Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more.
- Updated reference on drug approval processes in key global markets
- Provides comprehensive coverage of concepts and regulatory affairs
- Presents a concise compilation of the regulatory requirements of different countries
- Introduces the fundamentals of manufacturing controls and their regulatory importance
Sprache
Verlagsort
Verlagsgruppe
Elsevier Science & Techn.
Dateigröße
ISBN-13
978-0-12-822223-2 (9780128222232)
Schweitzer Klassifikation
1. Documentation in Pharmaceutical industry
2. Generic drugs product development
3. CFR (CODE OF FEDERAL REGULATION)
4. ANDA regulatory approval process
5. NDA approval process
6. Post marketing surveillance
7. US registration for foreign drugs
8. Regulation for combination products and medical devices
9. CTD and ECTD formats
10. Regulatory Guidelines of ICH-Q, S E, M
11. Regulatory requirements of EU, MHRA, TGA and ROW countries
12. Global submission of IND, NDA, ANDA
13. Investigation of medicinal products dossier
14. Regulatory Affairs in Clinical trials
15. Pharmacovigilance safety monitoring
