CDSA works on a national mandate to build capacity and capability in the area of clinical development and translational research in India. We, at CDSA continually strive to bring in interactive learning opportunities for clinical researchers, ethics committee members, scientists, biomedical researchers and all other personnel involved in clinical development and translational research.
CDSA has worked in the last year with the Indian drug regulators, Central Drugs Standard Control Organisation (CDSCO) and Indian Council of Medical Research (ICMR) in training biomedical researchers, clinicians, scientists, ethics committee members. Key areas covered include Good Clinical Practice (GCP), Good Clinical Laboratory Practice (GCLP), Good Laboratory Practice (GLP), and ethics in clinical research and clinical research methodology (CRM).
Dissemination of latest guidelines: India’s ethical guidelines and stem cell research guideline underwent a revision after several years. CDSA in association with ICMR has been conducting 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 covers ICMR-DBT’s national guideline for stem cell research 2017. During 2017-18, four programs were conducted at Ahmedabad, Vishakhapatnam, Kochi and Guwahati which were attended by over 4000 participants. The program wholly supported by CDSA and participants were not charged any registration fees. The feedback received from participants for all four programmes (overall 776) was extremely positive with the median score at each site of 8 on a scale of 1 (poor) to 10 (excellent) for content, relevance and clarity of presentations There are six more similar programs planned across India during 2018-19.
Supporting Centres of Excellence (COEs) to deliver training programmes: A new initiative was initiated to reach out to more target audience by supporting our COE partners deliver CDSA co-branded programs. Three were conducted this year (2 with JSS, Mysuru and 1 with CCDC, Gurugram). The topics covered were Research Methodology and Biostatistics using SPSS (JSS), Public Health Nutrition Research Methods and Policy Course (CCDC) and Critical thinking and GCP (JSS).
Capacity and capability building in clinical research: In keeping with our national mandate. a 2-day residential clinical research methodology course was delivered at the CDSA site for 33clinician/research scientists awarded with Wellcome Trust DBT fellowships and project grants. This program was very well received with all attending participants.
National series on Laboratory Quality Management System (LQMS): This series was initiated in 2016-17 in collaboration with National Institute of Biologicals (NIB), an apex regulatory institute. This year on public demand a residential hands-on LQMS course was conducted on diagnostics attended by 45 participants from 34 institutes and industry. A handbook developed from this program is being taken up by CDSCO for national implementation.
Delivering training to far off and unrepresented areas: India is a vast country and we made special efforts to reach out to more distant regions and unrepresented areas like North East Region and smaller Tier 2 or 3 cities.
Other contribution by CDSA Training Team
Indian Institute of Management (IIM), Ahmedabad: CDSA was a member of the International Programme Committee of the 3rd Conference on Advances in Healthcare Management Services (three years in a row) at IIM Ahmedabad. CDSA contributed in designing the program format, being faculty and getting national experts with main focus on innovation, regulation and evidence based policy decision on December 09-10, 2017.
National Institute of Training for Standardization, Bureau of Indian Standards (BIS), Noida: CDSA was a key faculty to the 8th international training programme on Laboratory Quality Management System from February 05-23, 2018 at BIS, Noida.
CDSA offers training in various areas related to clinical development, regulations (medical device, in vitro diagnostic kits, phytopharmaceuticals, new drugs, biopharmaceuticals, vaccines etc.), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Clinical Laboratory Practice (GCLP), current regulatory and ethical requirements for conducting clinical research or trials, clinical research methodology, Laboratory Quality Management System (LQMS), etc.
- Dr. Sucheta Banerjee Kurundkar, Director Training
- Ms. Vandana Chawla, Training Manager
- Mr. Jitender Ahuja, Training Co-ordinator