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Items tagged with GUIDANCE Files

192632/2006 EU RMP template

Updated on 22 December 2011

Risk Management Plan template for EU
Version: 27 September 2006

522 FDA device postmarket surveillance guidance

Updated on 12 January 2012

Device Safety Surveillance Guidance from FDA
Version: 27 April 2006

FDA draft guidance on reponding to information requests

Updated on 29 December 2011

Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices
Version: December 2011 draft

Guidance CT3

Updated on 18 December 2011

Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (‘CT-3’)
Version: 11 June 2011

UK guidance for serious breach

Updated on 15 December 2011

Guidance for notification of serious breaches of GCP or the trial protocol

Volume 9A v 2008

Updated on 29 December 2011

Guidelines on Pharmacovigilance for Medicinal Products for Human Use
Version: 2008

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