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NPTEL

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

NPTEL and Indian Institute of Technology Madras via YouTube

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Overview

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”

Syllabus

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.

Taught by

NPTEL-NOC IITM

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Reviews

4.5 rating, based on 6 Class Central reviews

Start your review of Current Regulatory Requirements for Conducting Clinical Trials in India for Investigational New Drugs - New Drug

  • Andreana Robin
    The class was really understandable and really nice. It helps to gain more knowledge about the given concept.
    Thank you
  • Manthan Shirke
    The course taught me a lot about the rules for introducing new medicines (IND). It covered everything from safety to how the trials should be done. It helped me understand the steps needed to get approval. The course used real examples to explain things, making it easier to grasp.

    It wasn't just theory; the course also showed how these rules work in real life. This way, I not only learned the rules but also how to apply them practically. The course made the sometimes complex regulatory stuff easier to understand.

    In the end, I feel more confident about understanding and following the rules for getting new drugs approved. The course was a helpful guide to navigate through the whole process.
  • Dr Aquil Ahmad Faruqui
    Current regulatory requirements for conducting clinical trials in India for investigational new drugs/new drug (Version 2.0)
  • Aarti Kashinath Giram
    It is a great online course, I get new updates on CDSCO and other regulatory information of India. I'm really very thankful to you .
  • Latika
    Actually, I saw this all video previously it was nice and well explained. But atleast provide the certificate of completion. Because everyone now a days ( CRO) asking for certification. And one more thing, why CDSCO not provide any guidelines for clinical trial of cosmetics and nutraceutical products it's really nessacary to apply the regulatory rule for this.
    By the way all session were explained nicely..
    Thank you
  • Profile image for Sharath Im
    Sharath Im
    I really liked the flexibility of this course. It worked well with busy scheduling, and the expectations were clear and upfront. However, overall, I found it effective and I enjoyed it.
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