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Presentation – Changes in FDA Investigational New Drug Safety Reporting Requirements

Posted on May 26, 2011 at 1:00pm

ITHS is sponsoring a presenation by Tory Lake, regulatory Affairs Director at the FHCRC. The FDA recently issued new guidance on safety reporting that went into effect March 28, 2011.

A live webcase via your desktop computer is available or you can attend in person. It will be archived ont he ITHS website for future viewing.


June 2011 – ITHS Clinical Research Education Series (CRES)

When: Tuesday 14 June 2011 at 12:00 to 1:00 PM

Where: Foege Auditorium room S060 (Genome Sciences) is located at south end of 15th Ave NE and Pacific St.

Presentation: Changes in FDA Investigational New Drug Safety Reporting Requirements
by Tory Lake, Regulatory Affairs Director at Fred Hutchinson Cancer Research Center.

Live webcast and recording for later viewing at:  https://www.iths.org/node/[number pending]

Go to the presentation link.  At the bottom of the page you will find another link for the Adobe Connect Meeting.  You will be prompted to provide some basic information first but there is no password needed.

Light refreshments:  Come early for salad, drinks, and cookies or bring your own lunch.

CRES Notification: If you or colleagues who like to be notified of the upcoming CRES presentation or you want to be removed from the mailing list, use the link below.


The ITHS Clinical Research Education Series is a monthly seminar series for investigators, scholars, and research staff to provide continuing education in the research regulations and conducting studies in compliance with Good Clinical Practice standards.  Particular emphasis is placed on providing practical advice and tools and on working within the UW and ITHS partner institutional systems (e.g., Seattle Children’s, Fred-Hutch, WWAMI region).

Please join us, Monica Jarrett

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