NOC:Current regulatory requirements for conducting clinical trials in India for investigational new drugs/new drug (Version 3.0), CDSA THSTI DBT
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NOC:Current regulatory requirements for conducting clinical trials in India for investigational new drugs/new drug (Version 3.0), CDSA THSTI DBT at NPTEL Overview
Duration | 4 weeks |
Total fee | Free |
Mode of learning | Online |
Credential | Certificate |
NOC:Current regulatory requirements for conducting clinical trials in India for investigational new drugs/new drug (Version 3.0), CDSA THSTI DBT at NPTEL Course details
- 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
- The current online course (Version 2) incorporates the changes and amendments that are part of these latest rules
- A series of brainstorming sessions were conducted by CDSA with CDSCO for incorporating the new updates and the feedback received from version 1 participants
- It also includes key issues that surfaced during the discussions at the six face-to-face programs (National workshop on regulatory compliance for accelerating innovations) that were conducted by CDSA (Dec 2018-July 2019) under the aegis of DBT, CDSCO, NITI Aayog, and BIRAC-NBM and inputs from the interactive session on NDCT Rules conducted by CDSA with CDSCO at THSTI (May 2019)
NOC:Current regulatory requirements for conducting clinical trials in India for investigational new drugs/new drug (Version 3.0), CDSA THSTI DBT at NPTEL Curriculum
Week 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
Week 2
PRE-CLINICAL DATA REQUIREMENTS
RULES GOVERNING CLINICAL TRIALS
Phases of clinical trial, forms, and fees
Regulatory pathway and data requirements for NDCT, 2019
Week 3
BA/BE study and study centers: Legal provisions
Guidelines to conduct BA/BE studies
Ethics Committee registration and re-registration
Week 4
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
Week 5
Important issues
Special concern
Clinical trial related guidelines (NDCT Rules)
Week 6
Content of Proposed Clinical Trial Protocol
Content of a Clinical Trial Report
Post Marketing Assessment & Clinical Trial Compensation
Week 7
Common observations during submission of CT/BA/BE protocol
Common observations during CT/BA/BE centre inspections
Drug development process: Overview
Week 8
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
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