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Date: 2016-05-20 Category: Not Applicable State: Union Government Country: India

Meeting conducted by Indian Society for Clinical Research at FDA Bhawan, CDSCO, Kotla Road, New Delhi 110002

Issued by Ministry of Health and Family Welfare · Central Drugs Standard Control Organization

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Executive Summary & Key Takeaways

What it means

  • The gazette notification announces a meeting conducted by the Indian Society for Clinical Research (ISCR) at FDA Bhawan, CDSCO, New Delhi on May 20, 2016.
  • The meeting's theme was focused on 'Clinical Research for meeting the Unmet Medical needs of Indian Patients' and how stakeholders can adopt a 'Patient First' mindset to expedite medicine delivery to those in need.

Key Changes

  • The meeting took place on May 20, 2016, from 2:30 PM to 5:30 PM.
  • The central focus of the discussion was to improve clinical research practices to address unmet medical needs of Indian patients.
  • The meeting emphasized a 'Patient First' approach for all stakeholders involved in the clinical research and drug development process.

Impact Analysis

Pharmaceutical Companies

  • Action: Identify and prioritize research projects addressing unmet medical needs in India.

Clinical Research Organizations (CROs)

  • Action: Develop strategies to improve patient recruitment and retention in clinical trials.

Regulatory Bodies (e.g., CDSCO)

  • Action: Promote transparency and patient involvement in regulatory decision-making.

Patients

  • Action: Participate in patient advocacy groups and provide feedback on clinical research initiatives.

Indian Society for Clinical Research (ISCR)

  • Action: Develop and disseminate educational resources on patient-centric clinical research.

Key Entities Referenced

Indian Society for Clinical Research (ISCR): An organization focused on promoting and advancing clinical research in India. FDA Bhawan, CDSCO: The office of the Central Drugs Standard Control Organization (CDSCO), the national regulatory authority for pharmaceuticals and medical devices in India. CDSCO: Central Drugs Standard Control Organisation, the national regulatory authority for pharmaceuticals and medical devices in India.
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Meeting conducted by Indian Society for Clinical Research at FDA Bhawan, CDSCO, Kotla Road, New Delhi 110002. On the Theme of “Clinical Research for meeting the Unmet Medical needs of Indian Patients-how can different stakeholders think and Act with a “Patient First” mindset in order to get medicines faster to the needy.” Timings 02.30pm to 05.30 pm on 20th May 2016.

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