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|Number of Training||3||10||14||171||21||291||17||19||18||18||178|
|Year||Name of the courses||Enrolled candidates|
|2019||Current regulatory requirements for conducting clinical trials in India||1707|
|Regulatory requirements for medical devices and IVDs in India|
|2020||Current regulatory requirements for conducting clinical trials in India for investigational new drug/new drug (Version 2.0)||4944|
|Regulatory requirements for medical devices including in vitro diagnostics in India (Version 2.0)|
|2021||Current regulatory requirements for conducting clinical trials in India for investigational new drug/new drug (Version 3.0)||5124|
A series of online courses were conducted on GCP and Bioethics for NBM-BIRAC Clinical Trials Network (CTN) sites. A total of 36 different sites among five CTN: Oncology (2 CTN’s), Ophthalmology, Rheumatology and Diabetology were trained in GCP and Bioethics. Strengthening of clinical trials research capacity in India’s friendly countries was conducted for Ind-CEPI for 8 countries (Afghanistan, Bahrain, Bhutan, Kenya, Myanmar, Nepal, Oman, and Vietnam). A ten series of programs on GCP, GCLP, ethics, and vaccine development were covered.Sensitization workshop for ethics committees for first in human infection studies was conducted for JIPMER, Puducherry.GCP and current regulatory and ethical requirements for conducting clinical trials/research in India as well as GCLP programs were conducted for ESIC medical college and Hospital Faridabad.Regulatory pathway workshop series was conducted for iTTO. Two Institutional Biosafety Training program was conducted for all THSTI lab personnel. A national program on GCP for various stakeholders and GCLP program for BCIL, NBM was also conducted successfully.
Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP) programs were conducted at NIRT-ICMR, Chennai. Two GCP and one GCLP programs were conducted for the National Biopharma Mission (NBM) at CDSA, THSTI, Faridabad, and Venture Center, Pune. GCP program was conducted at ICMR HQ, New Delhi.
With COVID lockdown, a series of online courses were conducted on GCP for NBM-BIRAC. Strengthening of clinical trials research capacity in neighbouring countries was conducted for Ind-CEPI for 7 countries (Afghanistan, Bangladesh, Bhutan, Maldives, Mauritius, Nepal, Sri Lanka). A ten series of programs on GCP, GCLP, ethics, and vaccine development were covered.
GCP and current regulatory and ethical requirements for conducting clinical trials/research in India programs were conducted for Dr. NTR University of Health Sciences, Vijayawada; JNIMS, Imphal; and Banaras Hindu University, Varanasi. National Workshop series on regulatory compliance for accelerating innovations as per the NITI Aayog recommendations was conducted with DBT, CDSCO, and BIRAC at Venture Center, Pune; C-CAMP, Bangalore; NIPER, Hyderabad & NIPER Guwahati; M.S University of Baroda, Vadodara
GCP and GCLP programs were conducted at the ICMR HQ New Delhi for ICMR Institutes, for CDSA Project team members at VMMC & Safdarjung Hospital, New Delhi, and at CDSA. Other programs conducted were a short course on research methodology for Welcome trust/DBT India; interactive meet on NDCT Rules, 2019; and Good Laboratory Practice (GLP), Documentation and Lab Safety program was conducted at THSTI.
A national series of dissemination of National Guidelines for Stem Cell Research and National Ethical Guidelines were conducted funded by CDSA with ICMR at Amrita Institute of Medical Sciences, Kochi and Guwahati Medical College, Guwahati. Short courses on Research Methodology, Critical thinking & GCP programs were conducted. GCP co-branded program with JSS University, Mysore was conducted at Langol, Manipur.
A workshop on Principles & Practice of Clinical Research at Hyderabad was conducted with NIH, USA funded by DBT-BIRAC and ICMR.
GCP and current regulatory and ethical requirements for conducting clinical trials/research in India were conducted at AIIMS, Bhopal; RIMS, Imphal; AIIMS Jodhpur, RGCI & RC; Delhi-NCR. GCLP workshop was conducted for ICMR at NIRT, Chennai. Several GCP programs were conducted for CDSA project team members at Delhi. A national workshop series on GLP Sensitization for faculty & scientists were conducted at Delhi & ITRC, Lucknow. GCP and GCLP programs were conducted at the Institute of Medicine, Nepal. Several other GCP programs were conducted for various institutes.
GCLP program for RePORT funded by DBT was conducted at NIRT-ICMR, Chennai; CDSA, THSTI. AIIMS CDSA EC Training workshops for IIT Delhi were conducted at AIIMS, New Delhi. Various GCP workshops were conducted across India at GMC, Mewat; AIIMS Bhubaneshwar; JSS, Mysore; ESIC Faridabad; VMMC & Safdarjung Hospital, New Delhi. Two national workshops on Laboratory Quality Management System (LQMS) in diagnostics were conducted at NIB, Noida. BIRAC CDSA Regulatory workshop series was conducted on biopharma, medical devices, IVDs, etc. funded by BIRAC.
A national series of dissemination of National Guidelines for Stem Cell Research and National Ethical Guidelines were conducted funded by CDSA with ICMR at AMC MET Medical College, Gandhinagar, and Andhra Medical College, Visakhapatnam.
BIRAC-CDSA Regulatory workshop on Emerging needs & regulations phytopharmaceuticals was conducted at CDSCO, Mumbai; medical devices and IVDs at CDSCO, Chennai. An awareness series on the Current Regulatory Requirements for Members of Institutional Ethics Committees were conducted funded by CDSA at PSGIMSR, Coimbatore, Tata Hospital, Mumbai; Tata Hospital, Kolkata; ANIIMS, Andamans; IISER, Pune
GCP programs funded by CDSA were conducted at Tata Hospital, Mumbai; Tata Hospital, Kolkata; and CDSA; KIMS, Karad; AMCH, Dibrugarh. Bioethics Certificate Course was conducted with Manipal University. Research methodology course was conducted funded by CDSA at CDSA, and ICGEB; PGIMER, Chandigarh. National workshop on LQMS in Biotherapeutics was conducted with NIB, Noida. Good Participatory Practice (GPP) was conducted at KIMS, Karad funded by IAVI. Several GCP, GLP, GCLP programs were conducted. GCP and GCLP programs were conducted at the Institute of Medicine, Nepal.