THSTI is an autonomous organisation of the Department of Biotechnology, Ministry of Science & Technology, Government of India.
CDSCO is the National Regulatory Authority (NRA) of India. It is under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India. This course is developed with the National Programme on Technology Enhanced Learning (NPTEL).
COURSE OBJECTIVES AND EXPECTED LEARNING OUTCOME
Current New Drugs and Clinical Trials Rules 2019 for conducting clinical trials of the new drug or investigational new drug (IND) to be manufactured or imported in India
Essential documents required for the conduct and approval of clinical trials, new drug/IND
Essence and purpose of important trial-related guidelines, such as Good Clinical Practice (GCP), national ethical guidelines for biomedical & health research for human participants (2017), etc
We invite you to join the course by clicking the below link (all the details about the course can be accessed from the link):
This course is free to enroll. The last date to register is February 15, 2021. The courses begin on February 15, 2021 .
Course duration : 8 weeks
The course is hosted on SWAYAM and accessed by anyone, anywhere at any time.
Tel: +91-129 287 6468
Email: [email protected]