{"product_id":"regulatory-affairs-in-the-pharmaceutical-industry-paperback-9780128222119","title":"Regulatory Affairs in the Pharmaceutical Industry (Paperback) 9780128222119","description":"\u003cfont face=\"Georgia\"\u003e\r\n\u003cp\u003e\u003cfont size=\"6\"\u003eRegulatory Affairs in the Pharmaceutical Industry\u003c\/font\u003e\u003cbr\u003e\r\n\r\n\r\n\u003c\/p\u003e\n\u003cp\u003e\u003cem\u003eA comprehensive reference on regulatory affairs in the global Pharmaceutical Industry\u003c\/em\u003e\u003c\/p\u003e\r\n\r\n\r\n\u003cp\u003e\u003cfont size=\"4\"\u003eJaved Ali (Edited by), Sanjula Baboota (Edited by)\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e9780128222119, Elsevier Science\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003ePaperback, published 15 November 2021\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e286 pages\u003cbr\u003e22.9 x 15.2 x 1.9 cm, 0.77 kg\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\r\n\r\n\r\n\u003cp align=\"justify\"\u003e\u003cstrong\u003e\u003cfont size=\"3\"\u003e\u003cp\u003e\u003ci\u003eRegulatory Affairs in the Pharmaceutical Industry\u003c\/i\u003e 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).\u003c\/p\u003e  \u003cp\u003eChapters 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.\u003c\/p\u003e\u003c\/font\u003e\u003c\/strong\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e1. Documentation in Pharmaceutical industry\u003cbr\u003e2. Generic drugs product development\u003cbr\u003e3. CFR (CODE OF FEDERAL REGULATION)\u003cbr\u003e4. ANDA regulatory approval process\u003cbr\u003e5. NDA approval process\u003cbr\u003e6. Post marketing surveillance\u003cbr\u003e7. US registration for foreign drugs\u003cbr\u003e8. Regulation for combination products and medical devices\u003cbr\u003e9. CTD and ECTD formats\u003cbr\u003e10. Regulatory Guidelines of ICH-Q, S E, M\u003cbr\u003e11. Regulatory requirements of EU, MHRA, TGA and ROW countries\u003cbr\u003e12. Global submission of IND, NDA, ANDA\u003cbr\u003e13. Investigation of medicinal products dossier\u003cbr\u003e14. Regulatory Affairs in Clinical trials\u003cbr\u003e15. Pharmacovigilance safety monitoring\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eSubject Areas: Pharmacy \/ dispensing [\u003ca title=\"See our other books on Pharmacy \/ dispensing\" href=\"https:\/\/freshlyprintedbooks.co.uk\/search?q=%22Pharmacy%20\/%20dispensing%20%5BMQP%5D%22\"\u003eMQP\u003c\/a\u003e], Pharmacology [\u003ca title=\"See our other books on Pharmacology\" href=\"https:\/\/freshlyprintedbooks.co.uk\/search?q=%22Pharmacology%20%5BMMG%5D%22\"\u003eMMG\u003c\/a\u003e], Pharmaceutical industries [\u003ca title=\"See our other books on Pharmaceutical industries\" href=\"https:\/\/freshlyprintedbooks.co.uk\/search?q=%22Pharmaceutical%20industries%20%5BKNDP%5D%22\"\u003eKNDP\u003c\/a\u003e], Production \u0026amp; quality control management [\u003ca title=\"See our other books on Production \u0026amp; quality control management\" href=\"https:\/\/freshlyprintedbooks.co.uk\/search?q=%22Production%20\u0026amp;%20quality%20control%20management%20%5BKJMV5%5D%22\"\u003eKJMV5\u003c\/a\u003e]\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\u003c\/font\u003e","brand":"Academic Press","offers":[{"title":"Default Title","offer_id":46648100225304,"sku":"9780128222119","price":133.99,"currency_code":"GBP","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0730\/2037\/5320\/products\/9780128222119.jpg?v=1694088287","url":"https:\/\/freshlyprintedbooks.co.uk\/products\/regulatory-affairs-in-the-pharmaceutical-industry-paperback-9780128222119","provider":"Freshly Printed Books","version":"1.0","type":"link"}