8th GCC Closed Forum

8th GCC - Working on CRO Consolidated Feedbacks to FDA on 2013 Revised FDA BMV Draft Guidance Dec. 5 Thursday Afteroon and Evening, Baltimore, MD, USA


Right after Crystal City V / AAPS Workshop at the same hotel - Hilton Baltimore

7 Teams have been built to work on different part of the guidance, comments and feedbacks will be consolidated, refined, and agreed upon at the Dec. 5-6 GCC Closed Forum.

Each Team will have 1 hour at the GCC meeting, hence, there will be three sessions including Thursday Afternoon Session, Thursday Evening Session, and Friday Morning Session. (All meals will be provided during the GCC meeting)

  • Introduction and background (including full, partial and cross-validation; new technologies; incurred sample reanalysis; glossary)
  • Chromatographic methods I:
    (RSM; selectivity; accuracy, precision, and recovery; calibration curve; sensitivity; reproducibility; stability)
  • Chromatographic methods II:
    (validated method: use, data analysis, and reporting)
  • Ligand binding assays I
    (key reagents; selectivity; accuracy, precision, and recovery; calibration curve; sensitivity; reproducibility; stability)
  • Ligand binding assays II
    (validated method: use, data analysis, and reporting)
  • Endogenous compounds; Biomarkers and Diagnostic kits
  • Documentation (including: system suitability/equilibration; summary information; documentation for method validation; documentation for bioanalytical report; appendix)
Team List

Due to the importance and special nature of this GCC we will extend the participation to 3 decision-making members from each CRO



Inclusion Criteria :

  • Presently actively working in the bioanalytical laboratory or department of a CRO;
  • Holding a decision making position within the company (bioanalytical executives and laboratory directors/associate directors or equivalent positions);
  • Max 2 representatives for each CRO;
  • More than 2 representatives could be accepted only if the CRO has multiple sites and/or involved in both small and large molecule bioanalysis.

Notes :

  • All the participants will be invited to participate in the authorship of an influential document based on the conclusion of the closed forum.
  • All the participants will be invited to contribute to the agenda of the closed forum.
  • We keep the right to refuse multiple registrations from the same company if the closed forum reaches a too large size to guarantee adequate discussion.

How to become a member of the GCC?


Simply Register to attend the GCC Closed Forum if you meet the above criteria.

Hotel Venue:

The 8th GCC Closed Forum will take place at the same venue of the CC V / AAPS Workshop at the Hilton Baltimore ( 401 West Pratt Street, Baltimore, MD, USA 21201).

AAPS Hotel Reservation (at group discount of $129 plus taxes) can be done at the weblink below:

http://www.hilton.com/en/hi/groups/personalized/B/BWICCHH-AAP-20131202/index.jhtml?WT.mc_id=POG