Latest News
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14 February 2013
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India's Union Health Ministry has released a new rule requiring all ethics committees to be registered with licensing authorities, part of a broader effort to improve the quality of clinical trials in
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Regulatory Update
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7 February 2013
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Indian regulators are out with two new clinical trials regulations that promise to reform some of the ethical hurdles that had plagued the sector in the past, including lax approval standards and a
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Regulatory Update
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3 January 2013
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Brazil’s National Health Surveillance Agency, Anvisa, has released a notice clarifying the rights of individuals who participate as clinical research subjects in the country. The notice specifies that
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Latest News
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21 December 2012
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This year marked two important anniversaries in the regulatory community. In the US, regulators noted the 50th anniversary of the passage of the Kefauver-Harris Amendments to the Federal Food, Drug
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Regulatory Update
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6 August 2012
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India's Ministry of Health has released three new draft rules governing the approval of clinical trials in India, the registration of ethics committees in charge of reviewing and approving
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Under RAPS
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25 July 2012
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For several years, studies conducted by RAPS have indicated talented regulatory staff are highly valued and sought after, and they are being rewarded with increased compensation.This trend has
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4 January 2012
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Global pharmaceutical manufacturers have been flocking to India since 2005 when guidelines restricting clinical trials were eased. The result: roughly 150,000 Indians participated in clinical trials
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