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7th Trial Master File Summit

January 16-18, 2018  |  Hyatt Regency Grand Cypress  |  Orlando, FL


The Trial Master File is the most crucial aspect of a clinical trial for a variety of reasons. However, a vigorous and informed approach is necessary if you aspire to:

  • Illustrate that GCP standards are upheld
  • Maintain inspection readiness
  • Avoid inefficiencies
  • Ensure quality of a clinical trial

The prominence of ExL Events’ Trial Master File Summit series is a testament to the dependability of this event to provide relevant content, disseminate replicable best practice, showcase the diversity of views, convene premier experts, illuminate effective strategies and provide industry-leading professional development.

Through select case studies, panel discussions and plenary sessions, participants will return to work better informed, better equipped and inspired to continue to improve QC, SOPs, and overall inspection readiness. This year’s summit has expanded to feature concurrent educational sessions on the morning of day two in order to 1) illuminate proven strategies, 2) economize and hone operations and 3) maintain effective partnerships.


Please Join Avoca for a Presentation on Inspection Readiness

Thursday, January 18  |  8:45am – 9:20am  |  Operations Track

Pass Your Inspections With a Risk-Based Approach in Accord With Trends and Anticipated Ramifications of ICH E6(R2)

  • Discuss MHRA’s emphasis on conducting a risk-based analysis and study case examples
  • Survey and compare inspections from different regulatory authorities
  • Hear assorted first-hand experiences of sponsors to uncover common pitfalls
  • Discuss foci of inspectors and what they inspected and didn’t inspect to determine compliance
  • Comply with ICH E6(R2) changes by adapting your risk-based tools and methods
  • Effect a risk-based approach to inspection readiness with tried and tested strategies


Co-presented by:

Steve Whittaker
Executive Director, The Avoca Quality Consortium®
Senior Consultant, The Avoca Group
Grace Crawford
Vice President Clinical Quality and Compliance,


For more information or to schedule a meeting with an Avoca representative, click here.