TY  - BOOK
AU  - Ali, Javed [Editor]
AU  - Baboota, Sanjula {Editor]
TI  - Regulatory affairs in the pharmaceutical industry
SN  - 9780128222119
U1  - 615.19 
PY  - 2022///
CY  - London
PB  - Academic Press
KW  - Pharmaceutical industry
KW  - Pharmaceutical policy
KW  - Drugs law--legislation
N1  - Table of content:
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
[https://shop.elsevier.com/books/regulatory-affairs-in-the-pharmaceutical-industry/ali/978-0-12-822211-9]
N2  - 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.

(https://shop.elsevier.com/books/regulatory-affairs-in-the-pharmaceutical-industry/ali/978-0-12-822211-9)
ER  -