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Ensure Inspection Readiness at the 7th Trial Master File Summit

The Trial Master File is the most crucial aspect of a clinical trial for a variety of reasons, and with the TMF industry constantly changing, it is imperative that you also consistently adapt to these developments. The 7th Trial Master File Summit will develop your professional skill set, wherewithal and savvy that you and your company must have to foster an inspection-ready culture while maintaining GCP and quality.


Register by this Friday, December 1, and mention Discount Code C945BLOG for 15% off registration.

The agenda will feature case studies that showcase the issues other companies have encountered and their resolutions. These industry-leading experts will share their personal experiences through the sessions highlighted below:

  • Case Study: Survey the Triumphs and Challenges of a Large-Scale eTMF Implementation on a Short Timeline 
    Mike CzaplickiClinical Documentation Operations ManagerGSK
  • Case Study: Maintain Consistency Through M&A and Other Transitions 
    Brenda BrownTMF Observation LeadPFIZER
  • Case Study: Discuss Inspection Readiness at Amgen
    Andrew WaiteDirector, Records and Information ManagementAMGEN
  • Case Study: Enhance Quality and Improve Inspection Readiness by Supporting and Allying With Internal Partners for In-House Studies 
    Renee FateDirector, Clinical Records ManagementALLERGAN
  • Case Study: Work Effectively on eTMF With a Strategic Partner CRO and Other CROs
    Martina DuevelSenior Global Clinical Project ManagerBAYER
  • Case Study: Holistic Approach for Achieving Quality Inspection Ready TMFs
    Jennifer PoulakosDirector, Development Quality Assurance, AGENSYS

REMEMBER Prices increase after this Friday, December 1. Take advantage of the Early Bird pricing to save $200 off the standard registration price.

If you are interested in sponsoring this event, please contact Eric Morrin, Senior Business Development Manager, at

Additional Resource

Executive Summary — 6th Trial Master File Summit, January 2017

posted in ExL Events News

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