Global Harmonization of Biomarker Validations – Topic Leaders: John Allinson, Afshin Safavi, Patrick Bennett, James Hulse

• Revisit 2013 GCC White Paper on Biomarker Validations
• New Developments and Progress, and New Challenges
• Reaching Consensus in the Global CRO community to provide harmonized inputs and recommendations from GCC on biomarker validation to the Global Regulators as well as the larger bioanlytical community

Health Canada Oct. 8 Notice – Topic Leaders: Bob Nicholson, Shane Karnik, Stephanie Cape

• GCC Survey sent to Global CRO Community
• Preliminary Evaluations on GCC Survey Results

FDA 483/Observation for not tabling data from failed runs in Validation – Topic Leader: Stephanie Cape

• Recently issued form 483 citations for "Failure to report all data from runs during method validation" even when these runs failed to meet SOP defined acceptance criteria.
• CRO feedback on current practices with regard to reporting of data (calibration, run QC, P&A, and other validation tests) from failed runs.

Electronic data management and integrity– Topic Leader: Rafiq Islam

• What's the "actual & unbiased" status in CRO?
• What about e-notebooks?
• What are the best practices?
• What's CRO experience with Regulators on this topic?

Extract stability– Topic Leader: Stephanie Cape

• Follow up from 9th WRIB FDA talk and 2015 White Paper recommendation
• CRO feedback on current procedures for extract stability vs. what reported in White Paper
• Alternative acceptable methods beyond FDA presentation

Processed batch acceptance– Topic Leader: Corey Nehls

• In addition to whole run acceptance criteria. EMA guideline and FDA Draft Guidance (BMV) touch on this topic, although criteria are not defined currently
• What's CRO's approach and perspective?
• Practical limitations in some cases – CRO experience

GCP Clinical Samples Bioanalysis– Topic Leader: Stephanie Cape

• What's the status of Compliance of USA-based bioanalytical labs to the 2012 EU EMA GCP "Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples"?
• How to handle the need to unblinding clinical sample during bioanalysis due to, Carryover Issues, Analytical Repeat, and ISR and ISS failures and investigations
• Is the Role & responsibilities of the Bioanalytical Principal Investigator (BPI) for Clinical Studies well established in all CROs?
• EU CROs vs. RoW CROs' experience with EU Agencies audit on GCP training and compliance in a bioanalytical lab, GCP inspections of bioanalytical lab

Characterization of critical reagents– Topic Leaders: Chris Beaver, Rafiq Islam, Masood Khan

• What is needed?
• What are current best practice?

Measures being considered by Authorities after recent CRO fraudulent behaviors– Topic Leader: María Cruz Caturla

• Overview of measures being proposed and impact on quality improvement.
• Impact and necessary changes on CROs daily work.
• GCP certification as alternative?