Workshop on Basic Good Clinical Practices (GCP) for Officers of Central & State Drugs Control Organization 10 th -11 th March, 2014
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1 Workshop on Basic Good Clinical Practices (GCP) for Officers of Central & State Drugs Control Organization 10 th -11 th March, 2014
2 Workshop on Basic Good Clinical Practices (GCP) for officers of Central & State Drug Control Organization was organized by Quality Assurance Division of Central Drugs Standard Control Organization (CDSCO) on 10 th - 11 th March, 2014 to increase the capacity and knowledge of the reviewers and Inspectors of CDSCO in regulatory oversight of clinical trials including GCP Inspections and Ethical Issues in Clinical Trials in India to implement effective Regulatory Oversight.
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 10 th March, 2014 Agenda of the Workshop Time Topic Speaker 9:00-9:30 Registration - 9:30-10:00 Inaugural session (Welcome address, Introduction of workshop and participants) CDSCO 10:00 10:15 Pre-Assessment CDSCO 10:15 10:30 Tea Break 10:30-11:30 Impact of recent Regulatory Changes For Conducting Clinical Trial In India CDSCO 11:30 12:00 Discussion Participants 12:00 12:45 Clinical Trial Inspection in India 12:45 13:30 Lunch Break Dr. Y.K Gupta, Prof and HOD, Department of Pharmacology AIIMS 13:30 14:00 Preparation For Site Visit Participants and Facilitators from CDSCO 14: Site Visit All Participants and Facilitators
5 11 th March, 2014 Time Topic Speaker 10:00 10:30 Impact of recent Regulatory Changes for Conducting Clinical Trial in India- cont. CDSCO 10:30-10:45 Tea Break 10:45-13:00 Report Preparation and Presentation All Participants 13:00 14:00 Lunch Break 14:00 15:15 Clinical trial inspection Checklist & common observations Mrs. Annam Visala, DDC (I) 15:15 15:45 Discussion Participants 15:45 16:00 Tea Break 16:00 17:00 Open discussion on visit and inspection checklist 17:00 17:15 Post Assessment CDSCO 17:15-17:30 Valedictory session CDSCO
6 List of Participants 10th and 11th March, 2014 S. No. Name Designation Organization Experts 1 Dr. Y.K. Gupta Professor & Head AIIMS, New Delhi Facilitators 2 Ms. Annam Visala Deputy Drugs Controller (India) CDSCO (HQ) 3 Dr. A. Ramkishan Deputy Drugs Controller (India) CDSCO (HQ) 4 Ms. Rubina Bose Assistant Drugs Controller (India) CDSCO (HQ) 5 Ms. Swati Srivastava Assistant Drugs Controller (India) CDSCO (HQ) 6 Mr. Somnath Basu Assistant Drugs Controller (India) CDSCO (HQ) 7 Mr. Gaurav Kumar Assistant Drugs Controller (India) CDSCO (HQ) 8 Mr. Sunil Kulshrestha Assistant Drugs Controller (India) CDSCO (HQ) 9 Dr. Ravi Kant Sharma Assistant Drugs Controller (India) CDSCO (HQ)
7 List of Participants from CDSCO 10 Mr. Saurabh Garg Drugs Inspector CDSCO (HQ) 11 Mr. Sourabh Mittal Drugs Inspector CDSCO (HQ) 12 Mr. Devendra Nath Drugs Inspector CDSCO (HQ) 13 Mr. Rakesh Negi Drugs Inspector CDSCO (HQ) 14 Mr. Amol Eknath Kandekar Drugs Inspector CDSCO (HQ) 15 Mr. Rahul Panwar Drugs Inspector CDSCO (HQ) 16 Mr. Ankur Bansal Drugs Inspector CDSCO (HQ) 17 Mr. Fahim Khan Drugs Inspector CDSCO (HQ) 18 Mr. Sachin Yadaorao Bhagwate Drugs Inspector CDSCO (HQ) 19 Mr. Sri Babu Drugs Inspector CDSCO (HQ) 20 Mr. Deepak Kumar Sehrawat Drugs Inspector CDSCO (HQ) 21 Mr. Baljeet Singh Drugs Inspector CDSCO (HQ) 22 Mr. Dinesh Kumar Drugs Inspector CDSCO (HQ) 23 Mr. Popat Dattatraya Thorat Drugs Inspector CDSCO (HQ) 24 Mr. Manoj Choudhary Jatav Drugs Inspector CDSCO (HQ) 25 Mr. Pratyush Kumar Drugs Inspector CDSCO (HQ)
8 26 Mr. Arvind Singh Panwar Drugs Inspector CDSCO (HQ) 27 Dr. Vijai Singh Karwasara Drugs Inspector CDSCO (HQ) 28 Mr. Dileep Kumar Drugs Inspector CDSCO (HQ) 29 Ms. Suniti Choudhary Drugs Inspector CDSCO (HQ) 30 Ms. Nisha Kaushik Drugs Inspector CDSCO (HQ) 31 Mr. Saurabh Jain Drugs Inspector CDSCO (HQ) 32 Mr. Pushpraj Kumar Singh Drugs Inspector CDSCO (HQ) 33 Mr. Surender Kumar Kaswan Drugs Inspector CDSCO (HQ) 34 Mr. Sandeep Kumar Drugs Inspector CDSCO (HQ) 35 Mr. Rahul Singh Drugs Inspector CDSCO (HQ) 36 Mr. Abhinav Kapoor Drugs Inspector CDSCO (HQ) 37 Mr. Akash Rama Kondalkar Drugs Inspector CDSCO (HQ) 38 Mr. Munish Kakar Drugs Inspector Chandigarh 39 Mr. Arun Kumar Prashar Drugs Inspector Jammu 40 Mr. Kailash Chander Malik Drugs Inspector East Zone 41 Mr. Bikramaditya Chowdhury Drugs Inspector CDSCO (HQ) 42 Dr. Bikash Roy Drugs Inspector CDSCO (HQ) 43 Mr. Manish Horo Drugs Inspector CDSCO (HQ) 44 Ms. Kiran Singh Drugs Inspector CDSCO (HQ) 45 Mr. Bibekananda Behera Drugs Inspector CDSCO (HQ) 46 Mr. Shabeer Ashfaque Abdulla Drugs Inspector CDSCO (HQ)
9 List of Participants from States 47 Mr. Sushen Mazumder Drugs Inspector Assam 48 Ms. Shail Ambastha Drugs Inspector Jharkhand 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. Dr. A. Ramkishan, Deputy Drugs Controller (India), CDSCO addressed the importance of this workshop and highlighted the mandate, mission and vision of CDSCO, objective and expectation from this workshop. He also discussed on the topic Impact of recent Regulatory Changes for Conducting Clinical Trial in India.
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. Dr. Y.K. Gupta Professor & Head, AIIMS
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 Participants during the Pre-Assessment and Post-Assessment
14 Participants from State and CDSCO took keen interest during the Presentations
15 Facilitators along with Participants took keen interest during the Presentations
16 Ms. Swati Srivastava, Assistant Drugs Controller (India) guiding her group during preparation of presentation
17 Groups preparing their presentation on the observations during the Site Visit
18 Groups presenting their observations of Site Visit
19 Groups presenting their observations of Site Visit
20 Groups presenting their observations of Site Visit Dr. A. Ramkishan, DDC(I) giving his comments on the observations of the various groups
21 Group Photograph during closing ceremony of the workshop
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