Choose one course per day

TMF FOUNDATIONS | Tuesday, May 14, 2019
9:00AM-5:00PM TMF FOUNDATIONS: Understand TMF Fundamentals, Challenges, and Regulations and Explore TMF Management Best Practices

lisa leete, Clinical Document Manager, xencor
Jolanta Strus, Associate Principal Scientist, Clinical Research, Merck

Upon completion of this course, participants will know or be able to

  • Cite current laws, guidances and regulations governing TMF management
  • Define and list the essential elements that constitute a TMF
  • Outline the unique challenges of the TMF that add to the complexity of its management by various study team representatives
  • Explore strategies for relating the requirements for management of the to various TMF stakeholders of the study team representatives
  • Identify compelling benefits and the review the challenges of an eTMF system to stakeholders of disparate functions
  • Understand the interdependence of various components of a TMF Management Plan
  • Monitor TMFs for completeness and compliance
  • Anticipate pitfalls and proactively begin to troubleshoot issues
  • Address common challenges of the TMF professional
  • Learn about the Framework for the Destruction of Paper and TMF Exchange Mechanism
Remediation Strategies | Tuesday, May 14, 2019
9:00AM-5:00PM Remediation Strategies: Best Practices to Achieve Inspection Readiness and GCP Compliance

Lead - donna dorozinsky, President, just in time gcp
David Katzoff, VP System Integration Services, VALIANCE

Upon completion of this course, participants will know or be able to

  • Conduct gap assessments and implement process improvement that provides justification for resource allocation
  • Use metrics to develop KPIs with the intent to identify most relevant risk factors through quality reviews
  • Have a Quality Management System that is supported by processes
  • Build and manage cohesive cross-functional teams to drive remediation
  • Leveraging today’s technologies to prepare a road map to address company needs
  • Improve interoperability and speed and explore automation for extracting artifacts, emails and data
  • Implement remediation strategies that bolster processes and ensure inspection readiness
  • Manage migrations as a strategy for remediation
  • Direct remediation timelines and resourcing
eTMF System | Wednesday, May 15, 2019
9:00AM-5:00PM eTMF System: Understand Needs, Strategy, and SOPs to Choose and Utilize an eTMF

Lead - lisa mulcahy, Owner and Principal Consultant, mulcahy consulting
alex markiel, Director, Clinical Operations, Head of Clinical Document Control, pharmacyclics

Upon completion of this course, participants will know or be able to

  • Establish milestones for the project which will select, evaluate, and implement an eTMF system
  • Use the industry-available tool for assisting with the selection and evaluation of an eTMF system
  • Prioritize and communicate your company’s needs and other factors that may influence your choice of eTMF system
  • Organize an evaluation of eTMF systems based on company suitability, TMF operating models in use or to be in used in the future, process impact, people impact, risks, costs, and long-term benefits
  • Evaluate the various TMF Management operating models’ impacts on the process of utilizing an eTMF system to manage TMF documentation
  • Create and implement comprehensive transition plans based on your company’s priorities
  • Begin to prepare your company for TMF management process and system changes resulting from the implementation of an eTMF system
TMF Alliances and Collaborative Partnerships | Wednesday, May 15, 2019
9:00AM-5:00PM TMF Alliances and Collaborative Partnerships: Improve Quality and Inspection Readiness

Lead - Melissa Umbehauer Chiasson, Senior Manager, Process, Training and Compliance, TAKEDA
Robin Farmer, Associate Director, Document Control and Training, DYNAVAX TECHNOLOGIES
michelle ingraham, Manager, Information Governance and Compliance, ppd
michele weitz, Senior Director, GCP Compliance Operations, clovis oncology

Upon completion of this course, participants will know or be able to

  • Streamline processes to support work across-functional units to work with vendors
  • Consider and surmount obstacles to CRO oversight and QC in third party-owned systems
  • Build and manage cohesive cross-functional teams
  • Establish processes and KPIs that account for a CRO’s own assessment systems
  • Tailor a TMF Management Plan with streamlined processes throughout the study life cycle
  • Create a culture of quality through two-way communication
  • Plan and execute governance that facilitates change management
  • Improve interoperability and speed with AI for extracting artifacts, emails and data
  • Explain the essential requirements for machine-to-machine exchange of TMF content

*Courses include a continental breakfast, two networking breaks, and lunch.

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