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

June 2011 Median times to submission and licensing for 70 new active substances approved in five markets from 1997 to 2010

July 2011 Impact of priority, accelerated, and fast-track review status on US FDA approval times

August 2011 Process mapping of registration to reimbursement for new pharmaceuticals in UKMarch 2011 Optimal times for between-agency dialogue

September 2011  The percentage of NASs approved by CDER by one-cycle review process has increased

October 2011 Comparison of median time for submission to EM countries  from 1st world-wide approval (2006-2007 vs 2008-2009)

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

February 2012 The pharmaceutical industry Scorecard parameters considered by the regulatory authority

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

October 2012 Time to roll out new active substances to emerging markets and the influence of company resources

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)