EAPB Webinar on the Revision of the Clinical Trials Directive
On 5 December 2012, the European Association of Pharma Biotechnology’s (EAPB) Special Interest Group (SIG) on Regulatory Aspects during Biopharmaceutical Development held a webinar on the revision of the Clinical Trials Directive. Twenty people across four continents took part in the webinar, which was given by Axel Wenzel, EAPB board member and head of the SIG. He explained the current developments in the European Union on the revision of Directive 2001/20/EC, which is known as the Clinical Trials Directive. The European Commission has issued a Proposal for a Regulation on Clinical Trials on Medicinal Products for Human Use, which would replace the Clinical Trials Directive. During the webinar, Wenzel explained the fundamental meaning of this proposal for companies and academia.
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