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Overview of Drugs & Cosmetics Act and Rules thereunder
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Classroom Contents
Current Regulatory Requirements for Conducting Clinical Trials in India for Investigational New Drugs - New Drug
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- 1 Introductory Video 1
- 2 Courses Overview
- 3 Overview of Indian regulatory system
- 4 Overview of Drugs & Cosmetics Act and Rules thereunder
- 5 Overview of New Drugs and Clinical Trials Rules, 2019
- 6 PRE-CLINICAL DATA REQUIREMENTS
- 7 RULES GOVERNING CLINICAL TRIALS
- 8 Phases of Clinical Trial, Forms, and Fees
- 9 Regulatory pathway and data requirements for NDCT, 2019
- 10 BA/BE study and study Centers: Legal provisions
- 11 Guidelines to conduct BA/BE studies
- 12 Ethics Committee registration and Re-registration
- 13 Ethical Considerations
- 14 Good Clinical Practice
- 15 Requirements for import/ manufacture of new drug/ IND for conducting clinical trials in India
- 16 Requirements for Import/ manufacture of new drug/ IND for sale/ distribution...
- 17 Important Issues
- 18 Special Concern
- 19 Clinical Trial Related Guidelines (NDCT Rules)
- 20 Content of Proposed Clinical Trial Protocol
- 21 Content of a Clinical Trial Report
- 22 Post Marketing Assessment & Clinical Trial Compensation
- 23 Common observations during submission of CT/BA/BE protocol
- 24 Common observations during CT/BA/BE centre inspections
- 25 Drug development process: Overview
- 26 Salient feature of NDCT 2019 - what's new in NDCT?
- 27 Online Submission 23A: SUGAM
- 28 ONLINE SUBMISSION (CTRI)
- 29 TABLES GIVEN IN NDCT 2019 AND ITS CONTENT
