Slide of the Month Archive
March 2011 Optimal times for between-agency dialogue
April 2011 Lowest number of NAS approvals in 2010 by both FDA and EMA in ten years
May 2011 Seven steps in the benefit-risk assessment of medicines
July 2011 Impact of priority, accelerated, and fast-track review status on US FDA approval times
September 2011 The percentage of NASs approved by CDER by one-cycle review process has increased
November 2011 Regulatory review process: what are enablers?
December 2011 Key factors likely to impact medicines development
January 2012 Project Ekho: Informing a new medicines development paradigm
March 2012 New active substances approved by EMA and FDA over 10 years
April 2012 Benefit-risk framework: purpose and involvement
May 2012 Proportion of 69 NASs approved by all ICH agencies from 2002-2011 by submission timing
June 2012 Different models of scientific assessment challenge benchmarking
August 2012 Comparing the registration to reimbursement pathway for new active substances in Europe
September 2012 The UMBRA Eight-Stage Benefit-Risk Framework
December 2012 Enablers of an effective regulatory review
February 2013 The ongoing involvement of patients in the research and development of medicines
March 2013 Assessment routes and timelines in Australia (2011)