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, Optimising and Managing the Quality of Clinical Vendors and Sites

Agenda – 2nd European Clinical Quality Oversight Forum



Day One

 Monday, 26 February

8:30 – 10:00

PRE-CONFERENCE WORKSHOP: ALIGNING TO ICH E6 R2
Identifying Critical Variables, Assessing Risk and Defining Control Measures for Aligning With ICH E6 R2


Keith Dorricott, Ambassador, METRICS CHAMPION CONSORTIUM (MCC)
Tammy Finnigan, Chief Operating Officer, TRIUMPH RESEARCH INTELLIGENCE

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


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

Panellists
Philip Lange Møller, Medicines Inspector, DANISH MEDICINES AGENCY
Heike Reinstaedtler, Director, Clinical Operations Quality, GSK VACCINES
Additional Panellist 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

8:30 – 8:45

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


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

8:45 – 9:30

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

12:15 – 13:15

Lunch


13:15 – 14:00

PFIZER CASE STUDY: QMS VENDOR ASSESSMENT
Leveraging a Quality Management System (QMS) to Qualify and Assess New Vendors for Study Engagement


Martin Thorley, Director, Vendor Quality Lead, PFIZER
Lynette J. Bojko, Director, Sourcing and Vendor Management, PFIZER

14:45 – 15:00

Network Break


15:00 – 16:00

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


Moderator
Dr. Janet Fernihough, MBA, Senior Consultant, NAVITAS LIFE SCIENCES

Panellists
Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP, Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC
Karen Hue, FRQA, Associate Director, Quality Assurance Europe, AIMMUNE THERAPEUTICS UK LIMITED
Siobhan Hurley, Clinical QA Program Manager, R&D Quality Assurance, ABBVIE
Bodo Lutz, Global Clinical Quality Assurance, Compliance and Data Integrity Officer, NOVARTIS

16:00 – 16:15

CHAIRPERSON’S CONCLUDING REMARKS


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


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