Monthly Archives: September 2010

Free Webinar – Regulatory Affairs and Compliance

Posted on 17 September 2010 by Meg Walz

Join Cato Research for a free educational webinar on Thursday 23 September 2010 at 2PM EST. Cato Research Scientist Catherine Sheppard will be presenting “Regulatory Affairs and Compliance: Common Sources of Deficiencies Identified by the Regulatory Authorities in the United … Continue reading →

Posted in FDA, Health Canada, Regulatory Strategy, Webinars | Tagged , , , | 1 Comment

Future of Clinical Trials Conference 2010

Posted on 15 September 2010 by Evan Richardson

The Future of Clinical Trials conference will be held in San Francisco, CA from 15-17 September 2010.  The focus of this year’s conference is, “Exploring Efficiencies and Strategies for Smarter Clinical Trials.”  The three day conference has an impressive list … Continue reading →

Posted in Conferences and Meetings, Statistics | Tagged , , , , | Comments Off

Health Canada Increases Acceptance of eCTD Submissions

Posted on 14 September 2010 by Ask-Cato.com Contributor

Great news! Health Canada issued a Notice on 20 August 2010 to inform sponsors about the new electronic submission options – not obligations – being provided to them.  The submission types now accepted in the eCTD format are: New Drug … Continue reading →

Posted in eCTD, Health Canada | Tagged , , | 1 Comment

Statistics and Statisticians in Clinical Trials – Beginning with the End in Mind

Posted on 9 September 2010 by Ask-Cato.com Contributor

Cover of The 7 Habits of Highly Effective People Begin with the end in mind … is imagination–the ability to envision in your mind what you cannot at present see with your eyes. It is based on the principle that all … Continue reading →

Posted in Clinical Trials, Statistics | Tagged , , , , , | 1 Comment

August 2010 FDA Guidances

Posted on 7 September 2010 by Guest Post

Image via Wikipedia Each month, Cato Research Regulatory Scientist Cathy Anderson compiles a list of the notable guidance documents released by the FDA.  Here’s a summary of the guidances released in August 2010 (links go directly to PDF documents). Special … Continue reading →

Posted in FDA, Industry News | Comments Off