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Wednesday, April 11 • 1:30pm - 3:00pm
Session X - GCP Track

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X-1  EU, Japan, and USA Inspection Readiness and Conduct 

Abstract: TBA

Category: TBA

Level of Content: TBA

X-2 Using Quality Gates and Quality Triggers for Real Time Compliance with ICH E6(R2)

Quality Management is a new concept for clinical research.  The Quality System Regulation (QSR) became effective for manufacturing in 1996 and stressed Quality Management.  So too, in 1996, ICH E6 became effective for clinical without a hint of Quality Management. Post QSR roll-out, clinical could barely spell QMS (Quality Management System) but the sound principles and values associated with a QMS inevitably began to permeate the lexicon of clinical operations.
Lexicon creep continued from the food, drug, biotech and device industries associated with manufacturing methods and software development including FTA, FEMA/FMECA, HACCP, ISO 14971 and others for identifying and controlling risk (aka risk management).  Clinical has also absorbed concepts from these and regulatory areas pertaining to risk identification and risk control.
Risk was only recently contemplated as part of Risk-Based Clinical Monitoring (RBCM).  Now the concept has moved beyond RBCM expanding into a broader meaning and application within the ICH E6 (R2), where the entire trial process is expected to undergo risk analysis and risk mitigation.
The use of Quality Gates and Quality Triggers will be discussed with analysis of specific options throughout the life of a trial.  A Quality Gate is a standard that must be met before moving to the next step in a process.  A Quality Trigger is an event or target parameter that triggers a quality action, either negative or positive.  Both can complement and add to quality metrics throughout a trial.

Good Clinical Practices

Level of Content:

avatar for Kerri Robles

Kerri Robles

Director, Quality Laboratory Practices, BMS

avatar for Jacqueline Bushong

Jacqueline Bushong

Director, CQA, Atara Biotherapeutics
Jacqueline (Jackie) Bushong RQAP-GCP, is the Director / Head of Clinical Quality Assurance at Atara Biopharmaceuticals in Westlake Village, CA. She has 20+ years of experience in pharmaceutical/biotech industry in the CQA profession. Previous employers include Kythera, Amgen, Chiron... Read More →

Rita Hattemer-Apostel

CEO/ Consultant, Verdandi AG
Rita Hattemer-Apostel is an expert in Quality Management and Good Clinical Practice Quality Assurance. Since 1994, she has performed more than 700 audits worldwide in all clinical trial areas at sponsors, CROs, laboratories, technical service providers, clinical investigators and... Read More →
avatar for Dorcie Jasperse

Dorcie Jasperse

Raland Compliance Partners, LLC
Dr. Dorcie Jasperse has over 30 years of experience in clinical trials and medical research. Working in the government, academic, and commercial settings as a data manager, statistician and epidemiologist, project and program manager, GCP auditor, and manager of GMP auditors.In her... Read More →

Wednesday April 11, 2018 1:30pm - 3:00pm PDT
Platinum 7&8