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Revision of the Clinical Trials Directive 2001/20/EC 28/02/2011

Posted by Shirley Hallam in Approvals, Regulatory.
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Following last year’s public consultation exercise to assess the functioning of the Clinical Trials Directive 2001/20/EC, the European Commission has issued a concept paper to assess the impact of proposed legislative changes.  The concept paper sets out a preliminary overview of potential changes to the directive, and invites responses on 18 specific consultation items.  Responses should be forwarded to the Commission by 13 May 2011 at the latest. 

The concept paper can be found at: http://ec.europa.eu/health/files/clinicaltrials/concept_paper_02-2011.pdf

Looking for a GCP Auditor? 02/02/2011

Posted by Shirley Hallam in GCP audit.
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Shirley Hallam has extensive experience of investigational site audits throughout Europe in phases I-IV in a wide range of therapeutic areas including oncology, haematology, rheumatology, cardiovascular and diabetes. Vendor audits, data management, archive facility and clinical study reports also conducted. In 2010 she completed BARQA Practical Pharmacovigilance Audit training.

Contact HallamPharma@aol.com for further information.