2nd European Clinical Quality Oversight Forum -

2nd European Clinical Quality Oversight Forum
26 – 27 February 2018
London, United Kingdom

Ensuring Trial Integrity by Effectively Assessing, Optimizing and Managing the Quality of Clinical Vendors and Sites

Agenda – 2nd European Clinical Quality Oversight Forum



Day One

 Monday, 26 February

10:30 – 12:00

Workshop Resumes


13:00 – 13:30

CHAIRPERSON’S OPENING REMARKS AND GLOBAL UPDATE


David Fryrear, Senior Director, Research and Development Quality Assurance, ABBVIE

14:15 – 15:15

PANEL: CROSS-AGENCY INSPECTION COLLABORATION
Understanding Experiences With Joint Inspections and the Comparison of Inspection Data Across Agencies


Panellists
Susan Callery-D’Amico, Vice President, R&D Quality Assurance, ABBVIE
Heike Reinstaedtler, Director, Clinical Operations Quality, GSK VACCINES
Additional Panellists TBD

16:30 – 17:15

FDA INSPECTION READINESS
Understanding How the FDA Evaluates Practices and Procedures in Clinical Studies


Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP, Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC


Day Two

 Tuesday, 27 February

8:45 – 9:00

CHAIRPERSON’S RECAP OF DAY ONE AND OPENING TO DAY TWO


David Fryrear, Senior Director, Research and Development Quality Assurance, ABBVIE

9:00 – 9:45

TRIAL MASTER FILE (TMF)
Defining an Inspection-Ready Trial Master File and Knowing What to Expect During an Inspection


Michele Weitz, Director, GCP Compliance Operations, CLOVIS ONCOLOGY

11:45 – 12:45

PANEL: DATA QUALITY OPTIMISATION
Examining Effective Strategies for Ensuring Data Integrity When Executing Risk-Based Management and Oversight Approaches


Panellists
Keith Dorricott, Ambassador, METRICS CHAMPION CONSORTIUM (MCC)
Siobhan Hurley, Clinical QA Programme Manager R&D, Quality Assurance, ABBVIE
Additional Panellists TBD

12:45 – 13:45

Lunch


14:30 – 15:30

PANEL: ICH E6 R2 COMPLIANCE
Reflecting on the Actions and Process Adjustments Taken to Achieve ICH E6 R2 Compliance


Panellists
Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP, Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC
Karen Hue, FRQA, Associate Director, Quality Assurance GCP, AIMMUNE THERAPEUTICS
Michele Weitz, Director, GCP Compliance Operations, CLOVIS ONCOLOGY

15:30 – 15:45

CHAIRPERSON’S CONCLUDING REMARKS


David Fryrear, Senior Director, Research and Development Quality Assurance, ABBVIE


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