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Webinar: Inspection Preparation With a Risk-Based Approach Consistent with ICH E6 (R2) Requirements

Wednesday, July 25, 2018  |  11:00-12:00 EDT

 

 

During this session, Steve Whittaker and Grace Crawford will focus on:

  • Comparison of inspections from different regulatory authorities
  • Foci of inspectors
  • First-hand experiences of sponsors to uncover common pitfalls
  • MHRA’s emphasis on conducting a risk-based analysis
  • Compliance with ICH E6 (R2) changes by adapting risk-based tools and methods
  • Effect a risk-based approach to inspection readiness with tried and tested strategies

 

This Webinar is Ideally Suited For:

Good Clinical Practice (or clinically focused) leaders, such as:

  • ​​Quality Assurance and Clinical Operations Professionals:  VPs, Executive Directors, Directors, Managers
  • Functional Managers and Directors for Data Management, Pharmacovigilance, Drug Safety, Medical Affairs, Regulatory Affairs
  • Centralized or Center of Excellence Roles for Inspection Coordination

 

Speakers:

 

Grace Crawford, VP Clinical Quality and Compliance, MedImmune
Grace joined MedImmune in April 2015 as head of the Clinical Quality & Compliance function responsible for supporting the Clinical Biologics area within MedImmune. Prior to that, Grace spent over 21 years at ICON where her main focus was leading the Clinical Quality Assurance Department. She is active in industry participating in forums such as the Society for Quality Assurance, the AVOCA Quality Consortium, and Linking Leaders Clinical “Quality” Roundtable. Before joining ICON, Grace was a medical technologist in the Clinical Laboratory at Bryn Mawr Hospital in Pennsylvania. She earned a Master of Science Degree in Clinical Microbiology at the Medical College of Pennsylvania.
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Steve Whittaker, Senior Consultant, The Avoca Group
Steve Whittaker is Executive Director for the Avoca Quality Consortium and Senior Consultant with The Avoca Group. He is also a lead consultant for the pharmaceutical, biotech, and CRO industries where he provides expertise in project management, pharmaceutical development, clinical development, outsourcing strategies and execution plans. His experience in drug development leadership roles, combined with his established professional network across these industries, provides unique and valuable insights for organizational leaders.
In 2009, Steve retired from Eli Lilly and Company, where he served as Chief Operating Officer/Sr. Director of Operations and Project Management for the Cardiovascular/Acute Care Platform. Steve also led the Global Clinical Research Sourcing Office and Lilly’s Project Management Center of Excellence.

 

And, don’t miss Steve Whittaker’s session, “Comparing how agencies conduct inspections. What are the implications of ICH E6 (R2), based on recent inspection experiences?” at ExL’s 7th Clinical Trials Inspection Readiness Summit: