[CMIC Group Whitepaper] For decades, analytical testing has played a [...]

Senior representatives of GCC member companies have thoroughly evaluated and discussed the new European Medicines Agency (EMA; July 2011 [1]) Guideline on Bioanalytical Method Validation (BMV), during the 4th GCC (23 October 2011, Washington DC, USA) and 5th GCC (14 November 2011, Barcelona, Spain) Closed Forums. These North American and European events provided a unique opportunity for CRO leaders to openly share opinions and perspectives and to agree on unified bioanalytical recommendations specifically in relation with the new EMA guideline.

The 2nd Global CRO Council (GCC) for Bioanalysis Closed Forum was held on 15 April, 2011 in Montreal, Canada. In attendance were 45 senior-level representatives from 39 CROs on behalf of eight countries.

The topic of Incurred Sample Stability (ISS) has generated considerable discussion within the bioanalytical community in recent years.  The subject was an integral part of the 7th Annual Workshop on Recent Issues of Bioanalysis (WRIB) held in Long Beach, California, USA, in April 2013, and at the Global CRO Council (GCC) meeting preceding it.  

An Open Letter written by the GCC describing the GCC survey results on stability data from co-administered and co-formulated drugs was sent to multiple regulatory authorities on 14 December 2011. This letter and further discussions at different GCC meetings lead to subsequent recommendations on this topic of widespread interest within the bioanalytical community over the past two years.