COURSE OBJECTIVE:
To provide an understanding of the Phase studies, Bioavailability and Bioequivalence studies and Good Clinical Practices in formulations development and approval
DESCRIPTION AND OUTLINE:
Phase-I, Phase-II, Phase-III and Phase-IV studies in New Drug Development, BA/BE Studies in ANDA submissions, understanding the standards and regulations that affect conducting clinical trials, basic understanding of ethical principles and data organization, clinical research designs, clinical outcomes and measurement tools, protocol development, data collection, analysis, monitoring, recording, auditing, regulations, liabilities and responsibilities of conducting research with human subjects.
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
