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To download Three Track Programme click here
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Clinical Research
Clinical Data Management
Bio Statistics & Medical Writing
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Clinical Research
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Registration & Tea - 8:45 - 9:30 Am |
Session-I INAUGURATION
(Time: 9:30 - 9:45 A.M)
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(Common for all three tracks)
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Time : 9:45 - 11:00 A.M
Chair : Dr. Suresh Menon, President ISCR
Co-Chair : Prof. Johan Karlberg, HKU
Topics
1. Welcome, President's Address, lighting Of Lamp
2. Growth of clinical research in Korea - Role of government and other stakeholders
- Prof. Dong-Ho Lee,
Director of Clinical Trial Center, Asan Medical Center
3. Global meltdown and impact on clinical development
- Dr. Ajit Mahadevan,
Partner, Business Advisory Services, Earnst & young
4. Government incentives for Clinical Research in India
- Dr MK Bhan, Secretary
to Govt. of India, Dept. of Biotechnology
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Time : 11:00 - 11:30 P.M.
Tea Break
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Session-II Navigating Indian regulatory requirements
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Time : 11:30 - 1:00 Am
Chair : Dr MK Bhan, Secretary to the Govt. of India,
Dept. of Biotechnology
Cochair : Dr Surinder Kher, Executive Director & CEO, Clinsys
Topics
1. Regulatory processes for biotech & vaccines
- Dr. Arani Chatterjee, Vice President, clinical Research, Panacea Biotech
Pvt. Ltd
2. Regulatory processes for NCEs & generics
- Dr. Kiran Marthak, Director, Veeda Clinical Research
3. Regulatory processes for medical devices/stem cells
- Dr. Ravikumar , Consultant Cardiologist, Fortis Malar Hospitals
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Time : 1:00 - 2:00 P.M.
Lunch Break
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Session - III Free Papers
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Time : 2:00 - 03:30 P.M.
Chair : Dr SM Sapatnekar, Director & Dean, CREMA
Co-Chair : Dr Tufail Syed, Managing Director, Medpace
Topics
1. Monitoring reports - a parameter of quality of clinical trial conduct at site
- Dr. Shruti
Aggarwal, Clinical Study Manager, Clininvent
2. Status of Ethics committees - Dr. Sauren Das, Country Head, Excel Lifesciences
3. Ethical Issues around informed consent in developing countries
- Dr. Mohanish Anand, Head , Clinical Research,
Pfizer Ltd
4. Knowledge and Skills for Clinical Research Industry Professionals- CRAs &
Project Managers - Dr. Samyuktha Ajay, Vice President, Corporate
Training and
Development, Siro Clinpharm
5. Data Query- A parameter of quality of case report form completion
- Ms. Varsha
Dumbre, Clininvent
6. ema inspections - Dr. Nalini Shah, Prof & Head, Dept of Endocrinology,
Seth GS Medical College & KEM
Hospital, Mumbai
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Time :03:30 Pm - 4:00 P.M.
Tea Break
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Session - IV Safety Vigil in Clinical Research
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Time : 4:00 - 05:30 P.M.
Chair : Dr. YK Gupta, professor
and Head, department of clinical pharmacology,
AIIMS, New
Delhi
Co-Chair : Dr. Sanjeev Ahuja, Chief executive officer & chief medical
officer, Eli lilly
Jubilant Joint
Venture
Topics
1. Safety processing and PSURs
- Dr. Rashmi Hegde, Director Pharmacovigilance,
Solvay pharmaceuticals
2. Managing PV outsourcing for global corporations - a case study
- Dr. Chitra Lele, Executive VP, Sciformix
3. Pharmacovigilance in practice
- Dr. YK Gupta, Professor and Head, Department
of Clinical Pharmacology,
AIIMS, New Delhi
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Session - V Changing paradigms of conducting clinical trials
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Time : 9:30 - 11:00 A.M.
Chair : Dr Rajiv Sarin,
Director, ACTREC
Co-Chair :Dr DS Bakhle, Senior Vice President & General Manager
India, Reliance
Clinical Research
Services
Topics
1. Challenges in conduct of investigator initiated research
- Dr. Purvish Parikh, Medical Oncologist,
Managing Director- AmeriCares
India Foundation
2. Biomarkers and newer endpoints in oncology
- Dr. Susan Galbraith,MBBS Phil, Vice President,
Oncology and Clinical
Biomarkers Discovery Medicine-
Clinical Pharmacology
3. Challenges in conducting psychiatry studies
- Dr. Prasad Rao, Psychiatry Specialist,
Asha Hospital
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Time: 11:00 - 11:30 A.M. Tea
Break
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Session - VI Dilemmas in Research Ethics - Panel Discussion
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Time :11:30 - 1:00 A.M.
Chair : Dr. UM Thatte, Prof. & Head, Dept of Clinical Pharmacology, Seth GS
Medical
College & KEM Hospital, Mumbai
Co-Chair :
Topics
1. Dr. Sandhya Srinivasan, Consultant & Freelance Journalist
2. Dr. A Bhatt, President, Clininvent Research Pvt. Ltd.
3. Dr. V Muthuswamy, Senior Deputy Director General(Retd.), ICMR
4. Dr. S Ghoshal, Sr. Asst. Editor, Business India.
5. Dr. Raghunadharao Digumarti, Prof & Head, Dept. of Medical Oncology, NIMS
6. Dr. Sonal Vora, Sr. Director,Clinical Research Unit, Sanofi-Aventis
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Time 1:00 - 2:00 P.M.
Lunch Break
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Session - VII Capacity building - challenges & Opportunities
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Time :2:00 - 03:30 P.M.
Chair : Dr. RJ Jha, Senior VP, Clinical Research,
Wockhardt Ltd.
Co-Chair :Dr. A Majumdar, Medical Director, Eli Lilly
Topics
1. Gap in site capacity
- Dr. Prem Pais, Dean & Professor of Medicine, St.John's Medical
College,
Bangalore, India and Head, Clinical Trials Division,
St. John’s Research John’s
Institute,St. National Academy of Health Sciences, Bangalore,
India.
2. Wider horizons of project management - beyond activities
- Ms. Suneela Thatte, Executive Director, Quintiles
3. Ethics committee training - an unmet need
- Dr. S Bavdekar, Professor of Pediatrics, Seth GS Medical
College and KEM
Hospital, Parel, Mumbai.
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Time : 03:30 P.M. - 4:00 P.M.Tea Break
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Session - VIII Valedictory
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(Common for all three tracks)
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Time : 4:00 - 05:30 P.M.
Chair : Vinod Raina, Professor and Head, Department
of Medical Oncology and
Head, Delhi
Cancer Registry, Institute Rotary Cancer Hospital, All India
Institute of
Medical Sciences.
Co-Chair : Dr. Chetan Tamhankar, Chief Operating Officer, Siro Clinpharm
Topics
1. International benchmarks for clinical operations
- Dr. Sylvia Demandewicz, Sr.Director, Business
Development, I3 Research
2. Asian benchmarks in clinical research
- Prof. Johan Karlberg, Director, Clinical Trials
Centre, Hong Kong Univ.
3. India R & D Roadmap - Dr. SK Bhattacharya, Additional Director General,
ICMR
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