NOC:Current Regulatory Requirements for Conducting Clinical Trials in India for Investigational New Drugs (Version 2.0) (USB)

Media Storage Type : 32 GB USB Stick

NPTEL Subject Matter Expert : Prof. Nandini K Kumar, Prof. Y. K. Gupta, Prof. D. K. Sable, Prof. Arun B. Ramteke, Prof. Rubina Bose, Prof. Sucheta Banerjee Kurundkar, Prof. Vishnu Rao

NPTEL Co-ordinating Institute : IIT Madras

NPTEL Lecture Count : 28

NPTEL Course Size : 15 GB

NPTEL PDF Text Transcription : Available and Included

NPTEL Subtitle Transcription : Available and Included (SRT)

Lecture Titles:

Lecture 1 - Courses Overview
Lecture 2 - Overview of Indian regulatory system
Lecture 3 - Overview of Drugs and Cosmetics Act and Rules thereunder
Lecture 4 - Overview of New Drugs and Clinical Trials Rules, 2019
Lecture 5 - Pre-Clinical Data Requirements
Lecture 6 - Rules Governing Clinical Trials
Lecture 7 - Phases of clinical trial, forms, and fees
Lecture 8 - Regulatory pathway and data requirements for NDCT, 2019
Lecture 9 - BA/BE study and study centers: Legal provisions
Lecture 10 - Guidelines to conduct BA/BE studies
Lecture 11 - Ethics Committee registration and re-registration
Lecture 12 - Ethical Considerations
Lecture 13 - Good Clinical Practice
Lecture 14 - Requirements for import/manufacture of new drug/IND for conducting clinical trials in India
Lecture 15 - Requirements for import/manufacture of new drug/IND for sale/ distribution and unapproved new drug for patients
Lecture 16 - Important issues
Lecture 17 - Special concern
Lecture 18 - Clinical trial related guidelines (NDCT Rules)
Lecture 19 - Content of Proposed Clinical Trial Protocol
Lecture 20 - Content of a Clinical Trial Report
Lecture 21 - Post Marketing Assessment and Clinical Trial Compensation
Lecture 22 - Common observations during submission of CT/BA/BE protocol
Lecture 23 - Common observations during CT/BA/BE centre inspections
Lecture 24 - Drug development process: Overview
Lecture 25 - Salient feature of NDCT 2019 - what's new in NDCT?
Lecture 26 - Online Submission 23A: Sugam
Lecture 27 - Online Submission (CTRI)
Lecture 28 - Tables Given in NDCT 2019 and its Content