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TMF Operations: a Quality and Regulatory Approach

March 19 - March 21

This marcus evans event will help clinical operations and documentation professionals to develop better practice and methods to improve safety and performance in clinical trials system while supporting more efficient inspection readiness. With various case studies and discussions platform, this conference will give the opportunity for attendees to boost their practical knowledge and professional experience on quality requirements within trial master plans using a risk based approach and CAPA methods, understanding the new GCP E6 (R2) requirements, discussing continual improvement, featuring electronic transfer, addressing the challenge of fragmented operations and systems with standardized processes. Let’s open the silos and learn from cross functional approach!

Attending this premier marcus evans conference will enable you to:

  • Integrate a quality approach into clinical operation routine
  • Align processes and requirements within multiple stakeholders and systems
  • Approach documentation, archive and records in a more efficient way
  • Control the completeness of your TMF with a robust plan
  • Learn practical experience on quality vendor oversight

Expert Speaker Panel includes:

  • Susan Callery-Damico, Vice President R&D Quality Assurance, Abbvie
  • Marion Pillwein, R&D Quality Risk Management Lead, Merck
  • Franck Gressier, Head Clinical Quality Assurance, Pierre Fabre
  • Heiner Gertzen, Head GxP Inspection & Audit Readiness, Sanofi
  • Martin Thorley, Vendor Quality Lead, Pfizer

 Special offers for Global Pharma Update members using code LS160-GPU when registering for this conference:

  • 2 day conference: -€200
  • 2 day conference & 1 workshop: -€250
  • 2 day conference & 2 workshops: -€350

(Not for solution providers and consultants)

Interested? If you feel that you are a good fit for this conference please visit the event website: https://goo.gl/1KiRuu

For more information simply send an email to melinih@marcusevanscy.com


March 19
March 21


Marcus Evans
+357 22849308


Berlin, Germany