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Event Details


TMF and Clinical Operations Quality Excellence

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Who should attend?

How to think the TMF operations within a broader quality system, assuring that completeness, compliance, integrity of data can be supported thanks to qualified organizational processes aligned with GCP expectations? The new marcus evans conference “TMF Operations: a Quality and Regulatory Approach” 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!


Getting The Best Framework For Integrating Quality Processes Into Clinical Documentation, Enhance Data Integrity And Risk Based Management Tools To Meet Inspection Readiness And Assure Vendor Quality Oversight

Key Topics

  • 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


Melini Hadjitheori

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