Workshop on Advanced Good Clinical Practices (GCP) for Officers of Central & State Drugs Control Organization 12 th -14 th March, 2014
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1 Workshop on Advanced Good Clinical Practices (GCP) for Officers of Central & State Drugs Control Organization 12 th -14 th March, 2014
2 As a part of NRA strengthening activities and capacity building, Central Drugs Standard Control Organization (CDSCO) had recruited large number of Drugs Inspectors. The Drugs Inspectors appointed in CDSCO have duties and responsibilities to discharge the functions under Drugs & Cosmetic Act and Rules and other job responsibilities such as inspections for certification of Pharmaceutical products as per WHO norms, inspection for licensing of biological products, large volume Parenterals and review of dossier submitted for the marketing authorization etc. CDSCO has planned and completed Three days workshop on Advanced Good Clinical Practices (GCP) at Hotel Metropolitan, Bangla Sahib Road, New Delhi from 12 th to 14 th March 2014.
3 Objective of the Workshop To improve the reviewing and inspection skills of the Drugs Inspectors of Central and State in regulatory oversight of clinical trials including GCP Inspections and Ethical Issues in Clinical Trials in India as a part of capacity building of the Indian Regulatory System.
4 12 th March, 2014 Agenda of the Workshop Time Topic Speaker 9:30-10:00 Registration - 10:00-10:30 Inaugural session (Welcome address, Introduction of workshop and participants) CDSCO 10:30 10:45 Pre-Assessment CDSCO 10:45 11:00 Tea Break 11:00-12:00 Challenges in Clinical trial inspections in India Dr. Y. K Gupta 12:00 13:00 Preparation for mock audit Participants 13:00 14:00 Lunch Break 14:00 15:00 Preparation for mock audit All participants 15:00 16:00 Clinical trial inspection Checklist & common observations 16:00 16:15 Tea Break Ms. A. Visala 16:15 17:30 Preparation for the Mock Audit Participants
5 13 th March, 2014 Time Topic Speaker 10:00 18:00 Mock Audit at Clinical Trial Sites All participants and facilitators from CDSCO 14 th March, 2014 Time Topic Speaker 10:00 11:00 Keynote Address on Clinical Trial Dr. A.K. Aggarwal 11:00 11:15 Tea Break 11:15-13:00 Report compilation of Mock Audit Participants 13:00 14:00 Lunch Break 14:00 15:45 Report compilation of Mock Audit Participants 15:45 16:00 Tea Break 16:00 16:45 Report compilation of Mock Audit Participants 16:45 17:15 Presentation of inspection Report Participants 17:15 17:30 Post Assessment CDSCO
6 List of Participants: - 12 th - 14 th March, 2014 S. No. Name Designation Organization 1 2 Dr. Y.K. Gupta Dr. A. K. Aggarwal Experts Professor & Head Professor of Excellence & Ex- Dean Facilitators AIIMS, New Delhi Maulana Azad Medical College, New Delhi 3 Ms. Annam Visala Deputy Drugs Controller (India) CDSCO (HQ) 4 Dr. A. Ramkishan Deputy Drugs Controller (India) CDSCO (HQ) 5 Ms. Rubina Bose Assistant Drugs Controller (India) 6 Ms. Swati Srivastava Assistant Drugs Controller (India) 7 Mr. Somnath Basu Assistant Drugs Controller (India) 8 Mr. Gaurav Kumar Assistant Drugs Controller (India) 9 Mr. Sunil Kulshrestha Assistant Drugs Controller (India) 10 Dr. Ravi Kant Sharma Assistant Drugs Controller (India) CDSCO (HQ) CDSCO (HQ) CDSCO (HQ) CDSCO (HQ) CDSCO (HQ) CDSCO (HQ)
7 List of Participants from CDSCO 11 Mr. Manish Singhal Drugs Inspector CDSCO (HQ) 12 Mr. Vinod Kumar Drugs Inspector CDSCO (HQ) 13 Ms. Nisha Sankhwar Drugs Inspector CDSCO (HQ) 14 Mr. Sella Senthil M Drugs Inspector CDSCO (HQ) 15 Mr. Yogesh Shelar Drugs Inspector CDSCO (HQ) 16 Mr. Shashi Paul Drugs Inspector CDSCO (HQ) 17 Mr. P.Manavalan Drugs Inspector Chandigarh 18 Mr. Sanjay Kumar Agrawal Drugs Inspector CDSCO (HQ) 19 Mr. Suresh Kumar Kalwaniya Drugs Inspector CDSCO (HQ) 20 Mr. Dharmvir Singh Drugs Inspector CDSCO (HQ) 21 Mr. Sushant Sharma Drugs Inspector Chandigarh 22 Ms. Bharti Bachloo Drugs Inspector Jammu 23 Mr. Rajesh Kumar Verma Drugs Inspector CDSCO (HQ) 24 Mr. Ashish Kumar Rai Drugs Inspector CDSCO (HQ) 25 Mr. Vinay Kumar Gupta Drugs Inspector CDSCO (HQ) 26 Mr. S. John Gerard Drugs Inspector CDSCO (HQ)
8 27 Mr. Sushanta Sarkar Drugs Inspector CDSCO (HQ) 28 Mr. C. Manivillavan Drugs Inspector CDSCO (HQ) 29 Mr. C. Arunachalam Drugs Inspector CDSCO (HQ) 30 Mr. Sidharth Sahai CDSCO (HQ) Drugs Inspector Malhotra 31 Mr. Mukesh Kumar Drugs Inspector CDSCO (HQ) List of Participants from States 32 Mr. Biswajit Das Gupta Drugs Inspector Bihar 33 Ms. Neha Shoree Zonal Licensing Authority Punjab 34 Mr. Man Mohan Taneja Senior Drugs Control Officer Haryana 35 Mr. Kanahaiyalal Agarwal Drugs Inspector Madhya Pradesh
9 After registration of all the participants, Ms. Rubina Bose, Assistant Drugs Controller (India), CDSCO welcomed all the experts and the participants and also gave brief introduction to the workshop. This was followed by pre-assessment and subsequent address to the participants by Dr. A. Ramkishan, Deputy Drugs Controller (India), CDSCO on the importance of this workshop.
10 Official Inauguration and welcome address of the workshop was made by Ms. Rubina Bose, Assistant Drugs Controller (India) Objective and Expectation of the workshop was explained by Dr. A. Ramkishan, Deputy Drugs Controller (India), CDSCO addressing participants
11 Dr. Y.K.Gupta, gave presentation on Clinical Trial Inspection". In his presentation he discussed Do s and Don ts of inspection. He also elaborated and discussed the various observations made by different regulatory agencies during clinical trial inspections.
12 Ms. Annam Visala, gave presentation on Clinical trial inspection Checklist & common observations. She also discussed about the importance of writing good inspection reports and how to write good inspection report. Ms. Annam Visala Deputy Drugs Controller (India)
13 Dr. A.K. Aggarwal, explained about the development and history of Clinical research in India.
14 Participants from State and CDSCO took keen interest during the Presentations
15 Participants from State and CDSCO took keen interest during the Presentations
16 Facilitators along with participants during the Presentations
17 Facilitators along with participants during the Presentations
18 Facilitators along with participants during the Presentations
19 Groups presenting their observations of Mock Audit
20 Groups presenting their observations of Mock Audit
21 Groups presenting their observations of Mock Audit Dr. A. Ramkishan, DDC(I) giving his comments on the observations of the various groups
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