PHM-Exch> India: report on The National Consultation on Regulation of Drug Trials.

[Claudio Schuftan]

From: Sama <sama.womenshealth at gmail.com>


We would like to announce the release of the *report* on  *‘The National
Consultation on Regulation of Drug Trials.*” The Consultation held in 2011,
was an effort towards initiating a dialogue around the existing gaps in
policy and its implementation vis-à-vis the regulation of drug trials,
towards developing an appropriate framework for future intervention
strategies in this regard. The Consultation was organised by Sama –Resource
Group for Women and Health and others.



Recognising the urgent need for furthering transparency in trials,
protection of participant rights, and implementation of the highest
standards of independent inquiry, this National-level Consultation was
attended by nearly 60 participants. It produced concrete recommendations
for policy and regulation on these issues.



Some of the main themes that were discussed at the Consultation include –
The new division of labour in commercialised research; Regulatory standards
vis-à-vis the conduct of clinical trials in India; Pressing dilemmas and
Issues with regard to the existing systems of regulation; Issues of public
health vis-à-vis clinical trials; role of ethics committees and Dilemmas in
governance. While the concluding session, facilitated a platform for
collective strategizing over future interventions towards people-centric
clinical research.



We would request, those of you who may be interested to write to us *
directly* at sama.womenshealth at gmail.com for a copy. The Report is priced
at US $3/- and an additional charge for postage.



 website: www.samawomenshealth.org
Blog:http://samawomenshealth.wordpress.com/
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