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Invited Speakers : Abstracts & Introduction
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Exports And Clinical Trials For Medical Devices
By
Dr. S. P. Adeshara, Executive Director, Sahajanand
Medical Technologies Pvt. Ltd.,
and Frm. Commissioner, FDCA, Gujarat |
Abstract:
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Definition of Medical Device
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Classifying Devices
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Current Technologies
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Industry Segments
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Global Clinical Trials
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Costs Macro and Micro View
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Regulatory Aspects
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DCGI Role
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Approval Timelines
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Checklist of documents for
seeking permission to conduct Clinical Trial with Medical
Devices under Drug category (With Drug / Without Drug) and
Device category
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Checklist of documents to be
submitted for Export License
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Current Trials being Conducted
in India – NIH Registered
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Global Trials in India
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Why India ?
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Interventional Cardiology
Device based Trials
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Issues in India
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Future of Medical Devices
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New Product Areas
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Market Implications
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Conclusions
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Clinical trial industry in
India accounts for ~ 1% of global trials but is likely to
increase up to 15%
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Lower cost and faster
recruitment potential is most important reason for it
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Several Indian and prestigious
Multi-national device based trials have already been
conducted and many more are in pipeline
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Some regulatory and local IRB
Accreditation issues need still to be addressed
Speaker's Introduction
Dr. Adeshara has remained as the Commissioner , FDCA
Gujarat State for more than 11 years and been instrumental
actively involved in the process of Regulatory Reforms for
Indian Medical Device Industry by Ministry Of Health &
Family Welfare, Govt. of India. Being the head of FDCA in
Gujarat State, which has more than 30 % contribution in
the production of Pharmaceuticals and Medical Devices in
India, his role has been prominent in implementation of
the Regulatory Reforms while at the same time mentoring
Indian Medical Device Industry for facing the challenges
of reforms.
Achievements:
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Awarded “BEST DRUG CONTROLLER OF 2002” by AIDCOF for
Sincere and Outstanding Works in Drug Control
Administration.
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Indian Pharmaceutical Association has awarded
“I.P.A.FELLOWSHIP 2002” for distinguished & Dedicated
Service to the Profession of Pharmacy.
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‘DIWA’, Maharashtra State, (Drugs Inspectors Welfare
Association) awarded ‘DIWA AWARD 2002’ for the Valuable
Regulatory contribution in Pharmacy Profession in Gujarat.
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Awarded “SCHROFF MEMORIAL NATIONAL AWARD - 2005” by IHPA
in 57th IPC at HYDERABAD.
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