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Online Course

Current regulatory requirements for conducting clinical trials in India for investigational new drug/new drug (Version 2.0)

NPTEL via Swayam

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Overview

As prescribed by the Drugs and Cosmetics Act 1940 and thereunder, it is pre-requisite for anyone to know about the current regulatory requirements prior to carrying out any clinical trial or before getting involved in new drug development or research for the purpose of seeking regulatory approval in India. In recent years there have been many changes/amendments in the clinical trial/new drug approval rules and regulations in India. It is important to know the right information as regulations can be misinterpreted. This knowledge when disseminated by the regulators themselves along with subject experts and experienced trainers, will have profound impact. Being an online course, it will address a larger section of public. Making it a ‘free course’ will allow many to acquire the knowledge at the comfort of their home without paying any money.   Version 1.0 of this online course was launched in early 2019 with 12 lectures as a four-week course. This online course (version 1.0) was attended by 1047 participants (Jan - Mar 2019). The release of the New Drugs and Clinical Trials (NDCT) Rules, 2019 on March 19, 2019 has steered a need to revise this online course as version 2.0 so that it can be updated with the recent advancements in regulatory knowledge. A series of brainstorming sessions were conducted by CDSA with CDSCO for incorporating the new updates, the feedback received (version 1.0 participants). Also, the deliberations from various face-to-face programs that were conducted by CDSA and inputs from the interactive session on NDCT Rules conducted by CDSA with CDSCO were incorporated to decide upon the contents of version 2.0. This course now has 24 lectures spread over a period of 8 weeks. This course also involves 8 weekly assignments and a final exit assessment. The exit assessment and weekly assignments are optional in nature. Only those who are willing to take certification exam by paying fees, can opt for this.   The course like version 1.0 is developed under the guidance of Shri A. B. Ramteke, Former Joint Drugs Controller (India) and presently Consultant, Regulatory Affairs at CDSA, THSTI, DBT along with CDSCO and subject experts. Few subject experts and trainers are invited to take 3-4 lectures to enrich the course. For example, CTRI lecture was taken by CTRI, ICMR. This course attempts to explain in simple language the fundamentals of current regulatory requirements for conducting clinical trials in India for investigational new drug (IND)/new drug.

TARGET AUDIENCE :The course is suitable for those involved in: Clinical trial and new drug development (R & D/manufacture/import) including investigators, regulatory affairs personnel, human ethics committee members, clinical trial team members/researchers, and any other person interested in this area; Industry (pharma, biotech, contract research organization, etc.); Academia

PRE-REQUISITES :Indian nationals working in this area are encouraged. There is no pre-requisite to undertake this course. It is suitable for personnel with scientific/medical background (BSc/MSc/PhD/B Pharm/M Pharm/BAMS/BHMS/BDS/MDS/MBBS/MD/DM). Personnel working in the area of drug development/clinical trials/research may benefit from this course.

INDUSTRY SUPPORT :Pharmaceutical companies, Research/Academic Institutions, Biomedical research organizations, Regulatory authorities, Medical colleges, Contract research organizations

 

 

Syllabus

COURSE LAYOUT Week 1 : Lecture 1: Introduction to Indian regulatory system Lecture 2: Introduction to D & C Act and Rules thereunder Lecture 3: Brief about NDCT Rules 2019   Week 2 : Lecture 4: Pre-clinical data requirements Lecture 5: Rules governing clinical trials Lecture 6A: Phases of clinical trial, forms and fees Lecture 6B: Regulatory pathway & data requirements for NDCT, 2019   Week 3 : Lecture 7: BA/BE study and study centres Lecture 8: BA/BE guidelines Lecture 9: EC registration /re-registration   Week 4 :Lecture 10: Ethical considerations Lecture 11: Good Clinical Practice Guidelines Lecture 12: Requirements for import/manufacture of new drug/IND   Week 5 :Lecture 13: Important issues Lecture 14: Special concern Lecture 15: Clinical trial related Guidelines   Week 6 :Lecture 16: Content of proposed protocol Lecture 17: Content of CT report Lecture 18: Post-marketing assessment and clinical trial compensation   Week 7 : Lecture 19: Common observations during submission of CT protocol Lecture 20: Common observations during CT /EC site Lecture 21: New Drug development & discovery   Week 8 : Lecture 22: Salient feature of NDCT 2019 (What's new in NDCT) Lecture 23: Online submission [Part-1: SUGAM and Part-2: CTRI] Lecture 24: Tables given in NDCT and its content  

Taught by

Prof. Arun B.Ramteke, Prof. Sucheta Banerjee Kurundkar, Prof. Nandini K Kumar, Prof. Y. K. Gupta, P

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