Current Regulatory Requirements for Conducting Clinical Trials in India for Investigational New Drugs - New Drug

COURSE OUTLINE : The course is developed by Clinical Development Services Agency (CDSA) in partnership with the Central Drugs Standard Control Organisation (CDSCO). The course is developed with NPTEL. Learn Overview of Indian regulatory system. Overview of Drugs & Cosmetics Act and Rules thereunder. Overview of New Drugs and Clinical Trials Rules, 2019. PRE-CLINICAL DATA REQUIREMENTS. RULES GOVERNING CLINICAL TRIALS. Phases of Clinical Trial, Forms, and Fees. Regulatory pathway and data requirements for NDCT, 2019. BA/BE study and study Centers: Legal provisions.

ABOUT INSTRUCTOR : Prof. Braj Bhushan is a professor of psychology at IIT Kanpur. His research interest lies in Cognitive Neuropsychology, Cognitive Factors in esign, Trauma Psychology. He has been awarded with many laurels some being “Our Common Future Fellowship (2010), Volkswagen Stiftung, Germany”, “Abstract Award (2008), International Association for Suicide Prevention, 3rd Asia Pacific Regional Conference of IASP, Hong Kong”, “In Search of Excellence’ Award (2004), IAAP and NAOP-I”, “Young Scientist Award (2002), Indian Science Congress Association”, “B.H.U. Merit and Prize Award (1991), Banaras Hindu University”

Introductory Video 1.
Courses Overview.
Overview of Indian regulatory system.
Overview of Drugs & Cosmetics Act and Rules thereunder.
Overview of New Drugs and Clinical Trials Rules, 2019.
PRE-CLINICAL DATA REQUIREMENTS.
RULES GOVERNING CLINICAL TRIALS.
Phases of Clinical Trial, Forms, and Fees.
Regulatory pathway and data requirements for NDCT, 2019.
BA/BE study and study Centers: Legal provisions.
Guidelines to conduct BA/BE studies.
Ethics Committee registration and Re-registration.
Ethical Considerations.
Good Clinical Practice.
Requirements for import/ manufacture of new drug/ IND for conducting clinical trials in India.
Requirements for Import/ manufacture of new drug/ IND for sale/ distribution....
Important Issues.
Special Concern.
Clinical Trial Related Guidelines (NDCT Rules).
Content of Proposed Clinical Trial Protocol.
Content of a Clinical Trial Report.
Post Marketing Assessment & Clinical Trial Compensation.
Common observations during submission of CT/BA/BE protocol.
Common observations during CT/BA/BE centre inspections.
Drug development process: Overview.
Salient feature of NDCT 2019 - what's new in NDCT?.
Online Submission 23A: SUGAM.
ONLINE SUBMISSION (CTRI).
TABLES GIVEN IN NDCT 2019 AND ITS CONTENT.