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EVENT HIGHLIGHTS

  • Augmented Professional Development
  • Pre-Conference Workshops
  • Self-Tailored Experience — Two Tracks
  • Unparalleled Networking
  • 150+ participants
  • Needs-Driven Sessions — Industry-Leading Board
  • Candid and Sharing — Selected Case Studies and Panels

2018 KEY TAKEAWAYS

  • Conduct trial oversight using tailored metrics and tools and proven methods
  • Manifest continuous improvement by streamlining processes without compromising Quality
  • Ensure Quality and data integrity using QC that are risk-based
  • Maintain inspection readiness through a TMF management plan informed by inspection trends
  • Work with internal stakeholders from outside of the clinical function and with CROs

TESTIMONIALS

"I come to this event every year, I consider it a top priority."
Clinical Trial Manager, AMGEN

"Liked how interactive the sessions were. Great conversations — picked up lots of good practice."
Clinical Trial Administrator, IMMUNOCORE

"The profound and deep insight into all the aspects of TMF management."
Head, Clinical Documentation, HIESI FARMACEUTICAL

"A lot of new information. It was very useful to know about TMF experience from other companies."
Senior Documentalist, PSI

"Excellent presentations. A lot of effort and enthusiasm from presenters and delegates. I networked more than I expected."
Senior Clinical Program Associate, ORION PHARMA

"Great case studies, very practical and applicable."
TMF Specialist, BIOMARIN

"ExL Events never disappoints. They provide a collaborative environment and most attendees are happy to network."
Chief Operating Officer, AVOCA GROUP

2017 AUDIENCE BREAKDOWN

Board


Martina Duevel
Systems Excellence Project Leader,
BAYER PHARMACEUTICALS

Lucy Hampshire
Director, Medicines Quality Organisation – Europe,
ELI LILLY

Wendy Koc
Senior Manager, Clinical Compliance,
GILEAD SCIENCES

Karen Roy
Chief Strategy Officer,
PHLEXGLOBAL

Vittoria Sparacio
Head, Clinical Documentation Operations, GSK R&D Processes, Clinical Platforms and Sciences,
GLAXOSMITHKLINE

Jane Twitchen
Associate Director of Records Systems and Operations,
BIOGEN

Anne-Mette Varney
Principal Competency Development Specialist,
NOVO NORDISK

Jeannette Dixon
Quality Consultant,
LUNDBECK

2017 Session Coverage

Sessions

Topics
(Click to View Sessions)

  • Review eTMF System Capabilities and Needs to Create a Clear Process and Efficient Ways to Utilise the System
    Eldin Rammell, Managing Director, RAMMELL CONSULTING
    Jane Twitchen, Associate Director, Global Clinical Operations, BIOGEN

  • Select and Implement an Out-of-the-Box eTMF System — An Interactive Workshop
    Lisa Mulcahy, TMF Management Consultant, MULCAHY CONSULTING

  • Ensure TMF Completeness
    Wendy Koc, Senior Manager Clinical Compliance, GILEAD SCIENCES

  • Case Study: Develop and Rollout a TMF Management Plan With CRO for Sandoz Biosimilar Clinical Development
    Claudia Panitz, Head Regulatory Readiness and Archival/GDO, NOVARTIS

  • Transition From TMF to eTMF: Tips and Tools for Minimizing the Pains of Change
    Patricia Santos-Serrao, Director, Clinical and Regulatory Solutions Pharmaceutical, Blood and Biologics, MASTERCONTROL

  • Panel: Utilise an eTMF System to Monitor All Aspects of the TMF Process, Vendors, Quality and Clinical Research Sites
    Moderator
    Jamie Toth, Head of TMF Operations, DAIICHI SANKYO
    Panellists
    Jeannette Dixon, Associate Director, Clinical Operations Quality Oversight, BIOGEN
    Chris Holland, Director, Clinical Documentation Operations, GLAXOSMITHKLINE
    Jeff Pilot, Senior Clinical Project Manager, NORGINE
    Eldin Rammell, Managing Director, RAMMELL CONSULTING

  • Take a Behind-the-Scenes Tour on Active eTMF Management
    Franciska Darmer, Director, Veeva Vault eTMF Strategy, VEEVA SYSTEMS

  • Address TMF Strategy Considerations for Essential Safety Documents to Be Compliant With Article 57
    Lucy Hampshire, Director, Medicines Quality Organisation - Europe, ELI LILLY
    Jennifer Maier, Associate Director, R&D Quality Compliance, ALEXION PHARMACEUTICALS

  • Case Study: Bolster eTMF System Compliance and Data Quality Though Metrics, Dashboards and Automation
    Timothy Rafferty, eTMF Quality and Metrics Manager, ROCHE

  • Oversee an eTMF Process for a CRO-Run Study With Proven Processes and Tools
    Katie Clark, Vice President, Product Management, WINGSPAN TECHNOLOGY, A QUINTILESIMS COMPANY
    Martin Hausten, Team Lead Global Document Specialist, Head of Global Document Quality Content, BOEHRINGER INGELHEIM

  • Assure TMF System Quality Through the Engagement of People and Establishment of Processes and Systems
    Mathias Wittig, Principal Consultant, NNIT SWITZERLAND AG

  • Case Study: Apply a Risk-Based Approach to Your TMF Process
    Ruth Coll, Senior Clinical Program Manager, TRIZELL

  • Case Study: Document and Content Management Part of a Robust Quality Management System
    Scott McCulloch, Associate Director, Development Sciences Quality, BIOMARIN EUROPE

  • Panel: Any More Burning Questions? Keep Calm and Carry on With Inspection Readiness
  • View All Topics
  • Quality
  • Data (Integrity) Quality
  • Document Management
  • Process
  • Audits/Inspections
  • Automation
  • Inspection Readiness
  • Trial Coordination/Management/Oversight
  • CRO Partnership
  • ICH E6(R2)
  • TMF Management Plan
  • Operations
  • Metrics Tools
  • eTMF
  • eTMF Implementation
  • Strategy
  • Change Management
  • Staff/Training, Leadership

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