Tag Archive: EMA

Feb 08 2013

The Changing Landscape of Postmarketing Safety Reporting

Drugs are approved for marketing on the basis of clinical trials that are, generally speaking, carried out on relatively small numbers of people.  The goal of these trials are to identify the risks inherent in taking a drug while also assessing the drug’s efficacy in the treatment of the intended indication.  However, once a drug …

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Nov 10 2011

Free Webinar – Optimal Clinical Study Designs and International Regulatory Strategies

Please join us at a joint webinar between the Netherlands Centre for Human Drug Development (CHDR) and Cato Research that addresses current challenges and provides clinical and regulatory strategies to the most expeditious and cost-effective path towards clinical proof of concept and approval. The webinar will be held on Tuesday, 15 November 2011 from 1:00 to 2:00 PM ET.

Jul 14 2011

Recap of the DIA Annual Meeting 2011

The 47th Annual DIA Meeting was held on 19-23 June 2011 in Chicago and was a great success with thousands of attendees from the health care industry and regulators from around the world including representatives from the FDA, the EMA, and many other global agencies. This year’s keynote speaker was the renowned AIDS researcher and …

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Jun 30 2011

Clinical Study Reports to STFs

Module 5 - No STF

When working with sponsors who are new to eCTD submissions, one of the most common questions we get is, “What is a Study Tagging File and why do we need one for each clinical study report?”  To explain the importance of Study Tagging Files, we’ve asked Jason Rock, the Chief Technology Officer of GlobalSubmit, to …

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May 03 2011

India: The next up and coming location to run clinical trials?

  Until recent years, clinical trials have been conducted primarily in the US and in Europe, due to higher health standards and overall standard of care for patients.  However, more and more pharmaceutical companies and contract research organizations (CROs) are being pressured to reduce timelines and costs.  Up until about a decade ago, India was …

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