Introduction to the ISCR Councils
ISCR has nine functioning councils which constitute the major activities of the Society. Each of the Councils has a Council Coordinator and Members who drive the respective agenda of the Councils, guided by the overall objectives and mission of the Society.
About Regulatory Council
The Regulatory Council consists of working in the regulatory departments of both sponsors as well as CROs. The effort has been to engage stakeholders and regulators in a process of continuous dialogue so that the voice of the clinical research fraternity is appropriately articulated to the decision makers.
Council Chair & Co-Chair
Chair
Ms. Sukanya Choudhury (GSK)
Co-chair
Sneha Gupta (Sanofi)
Aims
The aims of the Regulatory Council are to:
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Establish a rapport with key regulators involved in policy making/regulations involving clinical research in the country.
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The aims of the Regulatory Council are to:
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Establish a rapport with key regulators involved in policy making/regulations involving clinical research in the country.
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To engage with the DCGI and other influencers within the government particularly ICMR, senior bureaucrats associated with the Health Ministry, etc on the regulatory framework for clinical research in India.
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To conduct innovative training programs across the country on the regulatory aspects of clinical trial applications, namely filings and approvals.