COURSE OBJECTIVE:
To provide an understanding of the Regulatory Submissions (IND, NDA, ANDA - Dossier and DMF, COPP) related to CDSCO, USFDA, HPFBI, TGA, MHRA, MCC etc.
DESCRIPTION AND OUTLINE:
CDSCO, USFDA, HPFBI, TGA, MHRA, MCC laws, regulations, and Guidelines, investigational and marketing applications, technical writing, negotiation skills with Auditors, development of New Drug Application (NDA) submissions, labeling and drug Information, Common Technical Documents (CTD), Notice of Compliance (NOC), requirements for ongoing post-marketing surveillance and post-marketing changes, communication and management skills essential for the successful regulatory affairs professional in Pharma/Biotech industry.
COURSE FEATURES:
DURATION:
4-5 Hours a Day twice a week for about 7-8 weeks
(On Saturdays & Sundays to suit the working professionals / Industry)
MODE OF DELIVERY:
The total Study Material will be provided at the beginning of the course itself.
Direct Interaction with Subject Matter experts
4-5 Weeks of Class room Study
1-2 Weeks of Practical Exposure
1 Week for summing up
DURATION:
4 Hours a week for about 12 weeks
(Preferably in early Mornings & Evenings on Saturdays & Sundays)
MODE OF DELIVERY:
Total Study Material will be provided at the beginning of the course itself.
Online Interaction with Subject Matter experts through webinars
