Capacity Building Workshop on Ethics and Regulation of Clinical Trials in India,organized by Sama–Resource Group for Women and Health, to be held at Bhopal on December 18-19th, 2013

A similar workshop was conducted at Delhi in February, 2013. Sama has been consistently working on the issues of rights violations and ethical misconduct in clinical trials in India over the last 4 years. In recent past there have been many examples of clinical trials that have taken place that disregarded ethical aspects and participant rights. At the levels of planning, design and implementation, there exists a striking lack of transparency thus jeopardizing the reliability and validity of drug research in the absence of adequate regulatory jurisdiction and systematic review of the industry. Recent parliamentary a standing committee reports on the functioning of the CDSCO office and on the clinical trials conducted by PATH validate the concerns raised by civil society groups. Subsequent developments in the regulatory framework for the clinical trials make it even more appropriate to discuss the issues regarding clinical trials. In this context, we are organizing this capacity building workshop to inform and initiate dialogue with regard to existing regulatory and provisions regarding clinical trials.

 

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s