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U.S. and EU Individual Case Safety Reports <br><i>Roadmap to Success: Tips, Strategies for Global Implementation of ICH E2B(R3)</i>
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Audio CD/Transcript - Aug. 17, 2011 <p>
The Audio CD/Transcript will be shipped the week of Sept. 12, 2011.
</p>
$327.00
Audio CD/Transcript - Aug. 17, 2011 <p>
The Audio CD/Transcript will be shipped the week of Sept. 12, 2011.
</p>
$327.00
When
Event Description
Regulators worldwide have grown weary of safety concerns not reaching them fast enough. The FDA and EU are tackling this problem by implementing a new international data standard and reporting system -- HL7 ICSR.
In the U.S., this standard for drugs and biologics will be finalized soon, sometime in mid-2011.
What does this mean for you?