Pharmacovigilance in India - Guidance on Clinical Trial SAE

[Guest guest]

Recently,CDSCO came up with the " DRAFT GUIDANCE FOR INDUSTRY

ON REPORTING SERIOUS ADVERSE EVENTS OCCURING IN CLINICAL TRIALS " .

http://cdsco.nic.in/SAE%20GUIDELINES%2005-05-2011.pdf

This guidance came in May 2011 with a note that " Suggestion/comments on the

guidance documents if any may please be forwarded to CDSCO within fifteen days " .

Now, one cannot say for how long this guidance shall remain a draft.

Recently media actively covered the news related to the Clinical Trials in India

and the compensation related to the same.

If anyone is interested to read the complete news, you may visit:

http://pharmaco-epidemiology.blogspot.com/p/clinical-trials-in-india-dark-side.h\

tml

http://pharmaco-epidemiology.blogspot.com/p/indians-sitting-ducks-as-drug-trials\

..html

Best Regards,

Manoj

> > > > >

> > > > > Hello,

> > > > > The next discussion will run from 26-29 Aug 2011 on " ADR Monitoring "

> > > > which will

> > > > > be moderated by Dr Gitanjali Kothiyal.

> > > > > Welcome Dr.Geetanjali and please take over Netrum from 25th

> > > > Aug.evening.Please

> > > > > introduce your self before starting the discussion.

> > > > > Kunda Gharpure

> > > > >

> > > >

> > > >

> > > >

> > >

> > >

> > >

> > > --

> > > Dr.Manoj Swaminathan MBBS, MPH

> > >

> >

>