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GCP and Guideline Updates
Below you will find information on latest changes in the Clinical Research environment. You can search by region or by type of information. Much of this information is provided by our readers around the World.

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GCP Updates:
22/02/2010 New Version of Annexe 13
Category: Guideline
Region: Europe

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10/02/2010 EMEA revised Q&A document
Category: Guideline
Region:

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10/02/2010 Eudralex Vol 10 - New Q&A on AE reporting
Category: Guideline
Region: Europe

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02/11/2009 MHRA updated guidance on Serious Breaches
Category: Guideline
Region:

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26/08/2009 EMEA Revised Q and A document
Category: Guideline
Region: Europe

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26/08/2009 New EMEA guideline on Co-ordination of Inspections
Category: Guideline
Region: Europe

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19/08/2009 MHRA Issues GCP Inspection Metrics
Category: News item
Region: United Kingdom

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18/08/2009 EMEA and FDA GCP Initiative
Category: Guideline
Region: Europe

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18/08/2009 EMEA and FDA GCP Initiative
Category: Guideline
Region: United States

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13/08/2009 Registration of CROs In India
Category: Recommendation
Region: India

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24/07/2009 New EU Guideline on CR in Neonates
Category: Guideline
Region: Europe

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21/07/2009 2005 Statutory Instruments - Did you know?
Category: Regulation
Region: United Kingdom

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21/07/2009 EU Guideline on handling missing data
Category: Guideline
Region: Europe

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21/07/2009 FDA draft guidance on postmarketing CTs
Category: Guideline
Region: United States

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21/07/2009 Procedural Advice and FAQs on PIPs
Category: Regulation
Region: Europe

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15/07/2009 EU issues draft revised guideline
Category: Guideline
Region: Europe

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06/07/2009 EU Voluntary Harmonisation Procedure
Category: Advisory Body Changes
Region: Europe

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06/07/2009 Register of Clinical Trials in India
Category: Recommendation
Region: India

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05/07/2009 EudraLex Questions and Answers
Category: Guideline
Region: Europe

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03/07/2009 EMEA issue strategy paper on 3rd country data
Category: News item
Region: Europe

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23/06/2009 MHRA moves to Risk Assessment for inspections
Category: News item
Region: United Kingdom

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19/06/2009 New Version of Declaration of Helsinki
Category: Guideline
Region:

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Note: The Clinical Researcher cannot guarantee the accuracy of all the information and accepts no liability for use of the information provided here or the content of any external links provided. We advise you to verify any information given before you use it.

 

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