Agenda Released for 3rd Euro Clinical Quality Oversight Forum in London
Tuesday December 4th, 2018
ExL is excited to announce our 3rd European Clinical Quality Oversight Forum, taking place 25–26 February 2019 at the Hilton London Canary Wharf in London, UK.
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David Fryrear, Senior Director, Research and Development Quality Assurance, ABBVIE
REGULATORY UPDATE: MHRA INSPECTIONS
Understand What to Expect During an MHRA Inspection and Know How to Best Prepare
Paula Walker, Inspectorate Unit Manager for GCP/GPvP/GLP, MHRA
GCP RENOVATION – MODERNISATION OF ICH E8 AND E6
Evaluate the Revision of ICH E8 and E6 to Address Evolved Quality Concepts and Critical to Quality Factors
Melissa Mudrick, Vice President and Global Head, R&D Compliance, BIOGEN
Achieve a Confident State of Inspection Readiness With Proactive Risk-Based Oversight Tools
Irene Catherine Michas, B.A., M.Sc., Ph.D., Senior Consultant, THE AVOCA GROUP
SMALL COMPANY PERSPECTIVE: TRIAL MASTER FILE (TMF)
Design, Develop and Maintain an Inspection-Ready Trial Master File
Karen Hue, Director, Quality Assurance Europe, AIMMUNE THERAPEUTICS
HALF-DAY INTERACTIVE WORKSHOP
CRO OVERSIGHT POST ICH E6 R2
Examine the Impact of ICH E6 R2 on CRO Oversight and Develop an Effective Oversight Plan
Liz Wool, President, WOOL CONSULTING GROUP, INC.
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