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TMF ESSENTIALS: | Monday, August 12, 2019
9:00AM-5:00PM TMF ESSENTIALS: Process, Perspectives, Platforms, Parameters, Principles, and Precepts to Meet TMF Challenges and Expectations


Lead – Lisa Mulcahy, Owner and Principal Consultant, MULCAHY CONSULTING
June Buchanan, Associate Director, Clinical Operations, TESARO

TMFs are living sources of information/evidence for how the clinical study was conducted including the decisions made, and compliance with process, laws, and regulations. They should be treated with the priority and quality process they deserve. When done right, TMFs are an asset for a company during the conduct of the study as they facilitate clinical trial conduct and oversight. This course offers a comprehensive overview of the basic principles of a compliant TMF management process. The objective of the course is to review the critical components of the entire process. Participants will learn the main contributors to the process that make a TMF a compliant set of content; a repository which can stand up to the global regulations that govern it. This course will outline the essential elements for a complete, compliant TMF management process, including an introduction to the TMF Reference Model — the industry’s standard blueprint for the content and organization of the TMF.

Also known as TMF 101, this course surveys four dimensions of the Trial Master File – people, process, technology, and regulations that govern it all tied together for the participants to improve their skill to be better equipped administrators and managers of a TMF. Participants will also look at the roles of functional contributors and other stakeholders throughout the TMF life cycle. Participants will learn the importance of Quality Checks and Quality Reviews, TMF Management Plans, and other strategies for maintaining an inspection-ready TMF.

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

  • Cite current laws, guidances, and regulations that govern TMF administration
  • Cite recent and pending industrywide trends and publications; including a review of the TMF RM
  • Define and list the essential elements that constitute a compliant TMF management process
  • Understand how the content, processes, and location of the TMF changes over the TMF life cycle
  • Relate TMF requirements for management to various TMF stakeholders of the study team
  • Identify compelling benefits and review the challenges of utilizing an eTMF system to various stakeholders of functions that contribute to a TMF
  • Understand the interdependence of various components of a TMF Management Plan
  • Anticipate and cope with common TMF challenges
Ensure Compliant Documentation: | Monday, August 12, 2019
9:00AM-5:00PM ENSURE COMPLIANT DOCUMENTATION: Align Processes With the Work of TMF Contributors to Improve Inspection Readiness

Lead – Jamie Toth, Director and Head of TMF Operations, DAIICHI SANKYO
Barbara Novak, Senior Manager, Clinical Operations, KYOWA KIRIN PHARMACEUTICAL DEVELOPMENT
Heidi Dildine, Senior Specialist, Clinical Document Management and Inspection Readiness, TAKEDA

This course looks at the relationship between regulations and scoping your internal processes and system. Participants will return to work with an enhanced understanding of the dynamic landscape of global regulations, including PMDA, in order to make informed decisions about processes.

Participants of this course will know and be able to:

  • Optimize eTMF workflow with the way documents are created, collected, managed, and reported on
  • Audit internal processes of stakeholders at sites, CROs, and sponsors
  • Change processes and adjust the level of services resources to provide optimal oversight
  • Cite guidances, laws, and regulations that govern TMF, including MHRA and PMDA
  • Institute quality control to meet oversight requirements of ICH E6(R2) using a risk-based approach
  • Facilitate collaboration of cross-functional stakeholders to make informed and collaborative improvements to processes
  • Utilize past findings to do a full review of your processes
  • Know how technology can enhance processes related to decision-making, QC, analysis, oversight, monitoring, and workflows

*Courses include continental breakfast at 8AM, two networking breaks, and lunch.

RISK IDENTIFICATION | Tuesday, August 13, 2019
9:00AM-5:00PM RISK IDENTIFICATION: Develop and Execute a Strategic Plan to Correct a Gap in Processes, a Non-Compliance or Gap in Procedural Document, a TMF Completeness Gap, or Other Quality Issues


Lead – Donna Dorozinsky, President, JUST IN TIME GCP
Joanne Malia, Director, Clinical Documentation Management, REGENERON
Vinay Parachuri, Practice Head — Life Sciences, PHARMA TEK SOLUTIONS

Running an internal audit and conducting inspection preparation work is very important not only for when you anticipate a regulatory inspection, but it is also critical to ensure ongoing inspection readiness and compliance with procedural documents and study plans. But what happens when you identify a quality issue, a process that isn’t working or an internal audit prior to an inspection that identifies several gaps or quality issues.

Correcting these situations takes a strategic approach. Without a strategic approach, you risk chaos without results. A strategic plan that identifies issues and outlines a process for remediating these issues is critical to efficiently fixing the identified problem. This course will help you identify a strategic plan to ensure that you come back from all issues and concerns.

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

  • Understand the cause of your quality issues by backtracking your document process
  • Perform a gap analysis to identify risks and create and outline all quality concerns
  • Track your document life cycle from site to CRO to TMF and understand risk points
  • Understand current inspection trends and implications to your situation
  • Create a remediation plan based on your findings
  • Develop a short- and long-term plan to fix the situation to pass an inspection and then create a remediation plan to avoid issues going forward
  • Regain control of the document life cycle process and put quality checks in place to prevent document quality issues going forward
  • Close the books on the issues and ensure proper document filing going forward
TECHNOLOGY IMPROVEMENT | Tuesday, August 13, 2019
9:00AM-5:00PM TECHNOLOGY IMPROVEMENT: Align Processes and Technology to Improve Efficiency and SOPs


Lead - Marion Mays, VP, Client Solution & Quality Assurance, PHLEXGLOBAL
Jason Weinstein, Business Lead and Manager for eTMF, REGENERON
Marc Webb, Director, Expert Solutions, PHLEXGLOBAL

The Trial Master file has evolved over time in its function and capabilities. Beginning as a repository of clinical study artifacts, documents and data, it soon became a record of company processes, management and operations. Technology played a large part in the next leap in its evolution, allowing the TMF to facilitate the conduct of the study. eTMFs have evolved beyond study facilitation by becoming instruments for improvement in a myriad of arenas — internal collaboration, Quality, processes, and management.

Efficiency should not be underrated as an objective because having smooth operations is a prerequisite to achieving Inspection Readiness and Quality. You need to be sure that your processes and SOPs will ensure your success. Achieving a symbiosis between technology and processes means that you can make better decisions faster. This course will look at the tools and methods used to gather and analyze data, monitor trials, conducting oversight, and predicting and evaluating impact.

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

  • Optimize eTMF workflow through interoperable technologies with the way documents are created, collected, managed, and reported on
  • Prepare TMF management processes and system changes resulting from the implementation of an eTMF
  • Compare process challenges and solutions sponsor-owned vs. third-party-owned systems
  • Establish necessary processes to support the use of a system at the point of launch
  • Improve interoperability and speed with AI for extracting artifacts, emails, and data
  • Critique dashboards, measurements, and metrics for their impact and their value toward analysis that leads to improvements
  • Establish SOPs and KPIs that account for a CRO’s assessment systems
  • Streamline processes to support work across functional units to work with vendors
  • Plan and execute governance that facilitates change management and informed improvement
  • Explain the essential requirements for a machine-to-machine exchange of TMF content
  • Understand the implications of and available resources for the proposed TMF Exchange Mechanism for TMF automation
  • Implement cross-functional Quality review and inspection preparation

*Courses include a continental breakfast at 8AM, two networking breaks, and lunch.

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