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Category: Guidelines & Legislations

NIAID ClinRegs – India

  By admin Archives, Clinical Trials, Guidelines & Legislations

The NIAID ClinRegs website provides an online database of country-specific clinical research regulatory information designed to enable users to explore regulations within a country and compare requirements across countries. ClinRegs also provides links to official regulations and other key resources… Continue reading

Apex Committee turns down DCGI’s proposal on trial approval for FDCs, subsequent new drugs, vaccines

  By admin Archives, Clinical Trials, Guidelines & Legislations

Ramesh Shankar | PharmaBiz.com | Mumbai | 10 November 2014 The Union health ministry’s Apex Committee, headed by Union health secretary, has turned down a proposal by the Drugs Controller General of India (DCGI) to dispose of clinical trial proposals… Continue reading

China sets new requirements for hospitals running clinical trials

  By admin Archives, Clinical Trials, Guidelines & Legislations

Zachary Brennan | 10 Nov 2014 The Chinese authorities are supplementing their current regulations around clinical trials with new mandates for the hospitals that conduct the studies. Read full article You may also want to refer to:Training of Delhi Government… Continue reading

Latest Guidebook for Conducting Pharma Clinical Trials in China: From Regulations to Practice (2014 Edition)

  By admin Archives, Clinical Trials, Guidelines & Legislations

Access China Management Consulting Ltd | Region China | July 2014 China is one of the fastest growing global economies with a fifth population in the world, and is one of the largest healthcare markets around the world. Along with… Continue reading

CDSCO in the process of constituting 38 more new drug advisory committees

  By admin Archives, Clinical Trials, Guidelines & Legislations

Joseph Alexander | PharmaBiz.com | New Delhi | 26 May 2014 With a view to further beef up the process of approvals to clinical trials, the health ministry has begun the process of increasing the number of new drug advisory… Continue reading

Clinical Trials Regulation: a step in the right direction?

  By admin Archives, Clinical Trials, Guidelines & Legislations

The Lawyer | 23 April 2014 Read full article   You may also want to refer to:The Myth of Regulation: A critique of the 2008 Draft ART (Regulation) Bill and RulesParticipation in MoHFW meeting on Regulation and Monitoring of Clinical… Continue reading

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    Our Trainings and Capacity Building activities facilitate mobilization and provide support towards organizing around health issues and promoting health rights. They contribute to awareness building … Read more »

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    Sama undertakes Creation of Knowledge Resources and their Dissemination on different issues pertaining to women and health. This forms our core strategy on various issues and initiatives that Sama is involved in. Read more »

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