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July 2017 Updated version of full case released

April 2017  Full Idea to Market Case - small molecule and monoclonal antibody-  released

September 2016  Graybook Spreadsheet Tools released

March 20 2016  EMA launches PRIME scheme to accelerate approval of priority medicines see this link 

September 3 2015 Integrated addendum ICH E6 (GCP guideline) inlcuded in Quicklinks

Jan 6 2015  EMA publishes article on  the adaptive pathways approach -  see this link

October 8 2014 EMA to publish clinical study reports underpinning approvals after January 1 2015 See this link.

September 8 2014 EMA publishes leaflet on EU regulation, see this link.

July 8 2014 Posting of clinical trial results in EudraCT mandatory from July 21 2014 - see this link.

June 6 2014 The European Medicines Agency has selected the first two medicines to be included in its adaptive licensing pilot project.

May 29 2014 Janet Woodcock, Director of FDA's CEDR, discusses accelerated approval procedures on the FDA voice blog and cites latest FDA guidance on this topic.