Learn · Current Regulatory Requirements For Conducting Clinical Trials In India For Investigational New Drugs/New Drug (Version 3.0)
Lecture 27 of 28Week 8
ONLINE SUBMISSION (CTRI)
Prof. D. K. Sable and others · CDSA THSTI DBT
Credits and licence
- From
- Current Regulatory Requirements For Conducting Clinical Trials In India For Investigational New Drugs/New Drug (Version 3.0), CDSA THSTI DBT (at NPTEL)
- Licence
- CC BY-NC-SA, as NPTEL states it. Non-commercial use only.
- Attribution
- NPTEL states: "Distributed under Creative Commons Attribution-ShareAlike / CC BY - NC - SA", beside a BY-NC-SA badge. Coordinated by IIT Madras.
- Who can watch
- Teens profiles and older. How courses are placed
All the lectures
- Course 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 & unapproved new drug for patients
- 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