Translational Health Science and Technology Institute

Courses Offered

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Short courses

Past programs

CDSA has conducted several short courses funded by CDSA, some of them are enlisted below.

CDSA has played a vital role in the dissemination of the latest ethical guidelines and stem cell research guidelines of India. CDSA in association with ICMR conducted a nationwide national dissemination series on the ICMR’s national ethical guidelines for biomedical and health research involving human participants (2017) and ICMR’s national ethical guidelines for biomedical research involving children (2017). This series also covered ICMR-DBT’s national guideline for stem cell research (2017).

  • National awareness series: Current regulatory requirements for members of institutional ethics committees (2014-16): 15 courses with 1770 attendees from 955 registered EC
  • Regulatory series: Meet the regulators (2014-16) with CDSCO & DBT
  • National dissemination of ethical guidelines 2017 with ICMR
  • National dissemination of stem cell research guidelines 2017 with ICMR & DBT

There are some short courses funded by DBT-BIRAC-NBM and ICMR. They are

  • Good Clinical Practice
  • Good Clinical Laboratory Practice
  • Bioethics training programs

National programs

CDSA is conducting a series of programs on Good Clinical Practice, and Bioethics for the five Clinical Trial Networks (CTN) supported and conducted with the Department of Biotechnology (DBT) – Biotechnology Industry Research Assistance Council (BIRAC) – National Biopharma Mission (NBM). The CTN comprises thirty-six medical colleges, and hospitals selected by BIRAC-NBM focussed on four therapeutic areas which are oncology, rheumatology, ophthalmology, and diabetology. The main objective is to strengthen the CTN so that they can conduct clinical trials using global best practices.

Regulatory programs

CDSA will be conducting regulatory programs as interactive meets with present and former regulators, and subject matter experts in areas like medical devices, in-vitro diagnostics, biopharmaceuticals, phytopharmaceuticals, new drugs, and vaccines, etc. Please keep visiting to see the latest updates.

GxP programs

CDSA continues to strengthen the Good Practice (GxPs) courses in clinical development like Good Clinical Practice, and Good Clinical Laboratory Practice. Please keep visiting to see the latest updates.

Advanced course

CDSA has conducted advanced regulatory online courses on the MOOCs (Massive Open Online Courses) model in collaboration with the Indian drugs regulators, Central Drugs Standard Control Organisation (CDSCO). These online courses are developed with technical support from the National Programme on Technology Enhanced Learning (NPTEL) and hosted in the SWAYAM portal (Ministry of HRD) of the Government of India.

These courses are run on a four-quadrant approach. Quadrant-I is an e-Tutorial; which contains Video and Audio Content in an organized form along with the transcription of the video. Quadrant-II is e-Content; which shall contain; self-instructional material, e-Books, illustrations, case studies, presentations, etc, and also contain Web Resources such as further references, related Links, Open source Content on the Internet, Video, Case Studies, books including e-books, research papers & journals, etc. Quadrant-III is the Discussion forum for raising doubts and clarifying them on a near real-time basis by the Course Coordinator. Quadrant-IV is Assessment, which shall contain; Problems and Solutions, which could be in the form of Multiple Choice Questions, Fill in the blanks, Matching Questions, Short Answer Questions, Long Answer Questions, Quizzes, Assignments and solutions, Discussion forum topics, and setting up the FAQs, Clarifications on general misconceptions.

The courses are free to enroll and register. Certification is voluntary with a nominal fee and it includes both formative and summative assessments. The entire course and its certificate examination are coordinated and conducted by IIT Madras.

2019 – Completed; 1707 participated
2020 – Completed; 4944 participated
2021 – Completed; 5124 participants

Completed

Ongoing

Workshops

CDSA conducts various workshops from time to time in line with its national mandate. The recently completed workshop was conducted as per the recommendations of the NITI Aayog, on regulatory compliance for accelerating innovations with DBT and CDSCO. It was funded by DBT-BIRAC.

International programs

CDSA is conducting a series of programs on Good Clinical Practice, Ethical considerations in clinical research, Good Clinical Laboratory Practice, and Novel vaccine development and immunization policy in a pandemic. These programs are supported and conducted with the Department of Biotechnology (DBT) – Biotechnology Industry Research Assistance Council (BIRAC) – India – Coalition for Epidemic Preparedness Innovations (Ind-CEPI). These programs are developed to accelerate strengthening clinical trials research capacity in neighbouring and India’s friendly countries.