Regulatory Affairs in the Pharmaceutical Industry

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 INDICE: 1. Documentation in Pharmaceutical industry2. Generic drugs product development3. CFR (CODE OF FEDERAL REGULATION)4. ANDA regulatory approval process5. NDA approval process6. Post marketing surveillance7. US registration for foreign drugs8. Regulation for combination products and medical devices9. CTD and ECTD formats10. Regulatory Guidelines of ICH-Q, S E, M11. Regulatory requirements of EU, MHRA, TGA and ROW countries12. Global submission of IND, NDA, ANDA13. Investigation of medicinal products dossier14. Regulatory Affairs in Clinical trials15. Pharmacovigilance safety monitoring

• ISBN: 978-0-12-822211-9
• Editorial: Academic Press
• Encuadernacion: Rústica
• Páginas: 286
• Fecha Publicación: 15/11/2021
• Nº Volúmenes: 1
• Idioma: Inglés