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Europe - Workshops | Monday, 16 October 2017
Registration and Continental Breakfast
Review eTMF System Capabilities and Needs to Create a Clear Process and Efficient Ways to Utilise the System
An eTMF system is no longer something that organisations consider to be an optional extra. It’s now recognised as an essential tool that can help with the basic functions of collecting, sorting and ensuring the quality of your documents to ensure that the trial is GCP compliant. Further, it can and should be a critical tool to facilitate study management. Whether you have a purpose-designed eTMF system or a general document management system, you will need to have a process in place to utilise this technology strategically to improve your process and ensure alignment with your eTMF system. During this workshop, attendees will work their way through typical eTMF system functionality and align this with clinical trial processes to walk away with the understanding to:
  • Have full control and oversight of your eTMF system, so it becomes a user-friendly tool for study management
  • Understand enhancements and system updates
  • Create an efficient eTMF process workflow process, aligned with the way that trial documents are used and created
  • Utilise your technology to apply quality control
  • Have strategic processes to collect and file documents
*This workshop includes a 30-minute networking break.
Eldin Rammell, Managing Director, RAMMELL CONSULTING
Jane Twitchen, Associate Director, Global Clinical Operations, BIOGEN
Luncheon for Workshop A Attendees
Select and Implement an Out-of-the-Box eTMF System – An Interactive Workshop
Vetting eTMF systems can be a very large undertaking whether your company is large or small. The implementation project can be even larger and take extended time unless tight controls for scope and activity completion are adhered to by all. For the best chance of success, it is important to 1) use available tools/resources where they exist so as to not reinvent the wheel; 2) assign the right people to the project; and 3) garner heavy investment from senior management to ensure prioritisation in the project team members’ work schedules. This workshop will utilise a very recent, very successful case study of a small biotech company to review, step by step, through the eTMF system selection process and 21-day implementation project. Goals of the workshop attendees are:
  • Create the scope of the project, beginning with the development of the questions to understand the goals of the project from start to finish
  • Use the proper tool for the creation of the RFP for facilitating vendor vetting and selection
  • See the request for project approval and funding through the eyes of senior management
  • Review the critical-to-success roles on the eTMF system implementation team
  • Evaluate the project plan template determine and preempt possible delay and pitfalls
*This workshop includes a 30-minute networking break.
Lisa Mulcahy, TMF Management Consultant, MULCAHY CONSULTING
Workshop Day Concludes
Europe - Day One | Tuesday, 17 October 2017
Registration and Continental Breakfast
Co-Chairs’ Opening Remarks
Karen Roy, Senior Vice President, Client Solutions, PHLEXGLOBAL
Vittoria Sparacio, Head, Clinical Documentation Operations, GLAXOSMITHKLINE
An Interactive Exercise: Common Challenges and Suggested Best Practices From the MHRA Symposium
Karen Roy, Senior Vice President, Client Solutions, PHLEXGLOBAL
Vittoria Sparacio, Head, Clinical Documentation Operations, GLAXOSMITHKLINE
Networking Break
Case Study Develop and Roll Out 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 Minimising the Pains of Change
  • Hear recommendations for getting the most of your paper TMF
  • Transition from paper TMF to eTMF in a phased approach using prove n strategies
  • Discover how TMF management includes but is not limited to document management
  • Facilitate sharing and providing access to TMF content for third parties by plying metadata
Patricia Santos-Serrao, Director, Clinical and Regulatory Solutions Pharmaceutical, Blood and Biologics, MASTERCONTROL
Networking Luncheon
Sticker Program Drawing — Must be present at the time of the drawings to win.
Ensure TMF Process Completeness
Wendy Koç, Senior Manager Clinical Compliance, GILEAD SCIENCES
Panel Discussion Utilise an eTMF System to Monitor All Aspects of the TMF Process, Vendors, Quality and Clinical Research Sites
  • Understand how to utilise your eTMF system to monitor and enhance vendor governance
  • Recognise the changes underway in clinical quality oversight operations in light of the changing regulatory environment
  • Identify the benefits of a conceptual framework for a proactive approach for end-to-end management of issues generated through clinical research activities
  • Implement KPIs and metrics to monitor outsourced functions in order to have better oversight of the trial
  • Harness the impact of an eTMF system to increase quality

Jamie Toth, Head of TMF Operations, DAIICHI SANKYO


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

Networking Break
Take a Behind-the-Scenes Tour on Active eTMF Management
  • Achieve a timely and complete eTMF
  • Work in real-time and factors to consider
  • Balance time invested with quality and risk expectations
Franciska Darmer, Director, Vault Clinical Suite Strategy, EU, VEEVA SYSTEMS
Address TMF Strategy Considerations for Essential Safety Documents to Be Compliant With Article 57
  • Survey safety trial documents necessary to allow verification of the trial conduct and data quality
  • Incorporate of safety requirements in your TMF plan, index and filing strategy, and sponsor oversight
  • Overcome barriers to file safety documentation in eTMF systems
  • Discuss examples of how to manage during inspections and audits
Lucy Hampshire, Director, Medicines Quality Organisation - Europe, ELI LILLY
Jennifer Maier, Associate Director, R&D Quality Compliance, ALEXION PHARMACEUTICALS
Cocktails and Networking
Day One Concludes
Europe - Day Two | Wednesday, 18 October 2017
Registration Opens and Continental Breakfast
Co-Chairs’ Recap of Day One
Karen Roy, Senior Vice President, Client Solutions, PHLEXGLOBAL
Vittoria Sparacio, Head, Clinical Documentation Operations, GLAXOSMITHKLINE
Case Study Bolster eTMF System Compliance and Data Quality Through Metrics, Dashboards and Automation
  • Set objectives for eTMF monitoring
  • Establish KPIs
  • Survey techniques for gathering data and data assessment
  • Visualise and disseminate information effectively
  • Establish Trial Team Response protocols and feedback loops
  • Consider future possibilities with technological advancements such as marts, clouds, robots, machine learning
Timothy Rafferty, eTMF Quality and Metrics Manager, ROCHE
Oversee an eTMF Process for a CRO-Run Study With Proven Processes and Tools
  • Perform due diligence on a vendor eTMF process by identifying and prioritizing what you are looking for
  • Clarify sponsor needs and expectations for access to a CRO’s eTMF system
  • Survey the types of evidence sponsors should be prepared to provide
  • Vet electronic tools for supporting due diligence
  • Discuss actions that should be taken at closeout
Kathie 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
Networking Break
Assure TMF System Quality Through the Engagement of People and Establishment of Processes and Systems
  • Examine the direct correlation of proper TMF system quality management procedures for improved decision-making and inspection readiness
  • Analyse TMF data to assess the current quality of your TMF system and identify weaknesses
  • Leverage analysis conclusions and patterns to inform improvements to your document management system and tools
  • Harness metadata and a defined folder structure to engender an up-to-date TMF process
  • Identify areas of focus for further training and professional development via TMF system quality management
Matthias Wittig, Principal Consultant, NNIT Switzerland AG
Case Study Apply a Risk-Based Approach to Your TMF Process
  • Enhance your QC process and your approach to document management
  • Utilise risk to ensure a TMF system is of the best quality when originally put in the TMF process
  • Identify facets of the TMF process that have the highest probability for quality issues
  • Manage the impact of implementing an eTMF system under strict budget constraints
Ruth Coll, Senior Clinical Program Manager, TRIZELL
Networking Luncheon
Sticker Program Drawing — Must be present at the time of the drawings to win.
Case Study Document and Content Management Part of a Robust Quality Management System
  • Implement document and content management as integral components of a quality management system
  • Get an overview of methods for evaluating processes and operations
  • Demonstrate the process by which a pathway to improvement is delivered
Scott McCulloch, Associate Director, Development Sciences Quality, BIOMARIN EUROPE
Understand the Impact and Showcase the Process of Documentation Within the TMF Process
  • Look at the TMF system as a deliverable and not as a document structure
  • Comprehend the process of the TMF process and the larger picture of inspection preparation
  • Include ICH GCP R2 regulations into the oversight of documents from vendors
  • Modify a TMF structure so that an inspection can find documents and all corresponding documentation appropriately
Nancy Meyerson–Hess, Associate Partner; Former Head of Clinical Operations and Compliance, ADMEDICUM BUSINESS FOR PATIENTS; GRUNENTHAL
Networking Break
Panel Discussion Any More Burning Questions? — Keep Calm and Carry on With Inspection Readiness

Eldin Rammell, Managing Director, RAMMELL CONSULTING
Karen Roy, Senior Vice President, Client Solutions, PHLEXGLOBAL
Vittoria Sparacio, Head, Clinical Documentation Operations, GLAXOSMITHKLINE
Jane Twitchen, Associate Director, Global Clinical Operations, BIOGEN

Co-Chairs' Closing Remarks
Karen Roy, Senior Vice President, Client Solutions, PHLEXGLOBAL
Vittoria Sparacio, Head, Clinical Documentation Operations, GLAXOSMITHKLINE
Conference Concludes

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