Pre-Conference TMF Training Day | Tuesday, January 16, 2018
Registration and Continental Breakfast Begin

The management of the Trial Master File, the content created in support of a clinical study, doesn’t have to be complicated. It can be as easy as 1-2-3 if a pragmatic approach is taken. The first step is to know what exactly is the TMF and define what is in “it.” The next step is to associate the TMF content in all its forms to its Owners. The last step is to establish process to ensure the TMF is inspection-ready at all times. Included in this workshop will be the presentation of typical problems incurred by companies establishing the TMF and its associated management processes. Audience feedback will be sought for the sharing of ideas to overcoming the challenges.

This workshop is geared towards those who are new to the TMF field, though all levels of experience can benefit from attending. Concepts addressed will allow the attendee to build/expand their foundation so they then can get the most out of the remainder of the Summit. Experienced workshop leaders will present as well as lead attendees through exercises that incorporate solutions to challenges that TMF professionals face.  The workshop will address the following:

  • Using the TMF Reference Model to outline what’s in the TMF, and who owns the content
  • Review of the industry accepted requirements for management by those that create, collect, and also manage the TMF
  • Guidances, laws, and regulations that define and govern the TMF in the U.S., EU, and Japan
  • Typical problems faced and corresponding solutions
Louise Hawkins, Clinical Operations Manager, Clinical Operations, AGIOS PHARMACEUTICALS
Lisa Mulcahy, Owner and Principal Consultant, MULCAHY CONSULTING
Breakfast Workshop Concludes

If you are tasked with establishing the TMF management process at your company, you know that the end goal of having an inspection-ready TMF on an ongoing basis doesn’t just magically happen after the TMF management process is created and made effective. The work involved with successfully convincing into action and compliance 10, 15, 20 different functional groups to follow the defined processes is not small. Any success experienced does not come without a significant amount of assistance and oversight of the process by the TMF management team to ensure it is being followed according to expectations.

This seminar will be conducted using a carousel approach. Every group will have the opportunity to address a TMF challenge in timed segments. All groups will summarize the how they interpret the challenge and propose known working potential quick wins and long-term solutions for success based on their group members’ experiences.

  • Attendee-chosen challenges regarding the operationalizing of the TMF management process will be discussed with corresponding solutions proposed
  • An overview of the methodology for engaging people to be part of the solution instead of the problem will be provided
Alex Markiel, Director, Clinical Operations, Head of Clinical Document Control, PHARMACYCLICS
Lisa Mulcahy, Owner and Principal Consultant, MULCAHY CONSULTING
Supriya Shoroff, Associate Director, TMF, SAGE THERAPEUTICS
Seminar Concludes

The TMF Management Plan is a document that outlines the management of the TMF for a study. Standard industry practice dictates that a TMF Management Plan be created for each clinical study. However, the topics addressed within the TMF Management Plan can vary widely from company to company. The MHRA has provided an outline of topics important for inclusion in the plan and industry has identified additional ones based on best practices.

This workshop will review the expectations and best practices for topics to include in the TMF Management Plan. A few of the more complicated topics including expectations for quality reviews will be discussed in detail through small group exercises. Approaches for how, when, who and what will be presented by sponsor representative as well as the management of the outcome of the quality review and evidence of this conduct. This workshop promises a lively discussion that all attendees will benefit from; even those new to the TMF management field of work. Topics that will be addressed during this workshop are:

  • The TMF Management Plan in the eyes of the health authority representative
  • Why the TMF Management Plan is so crucial to the overall TMF management process
  • Definition of what is a quality review, how often one is to occur, tools used to conduct a quality review, and the evidence created as a result of the activity
Lisa Mulcahy, Owner and Principal Consultant, MULCAHY CONSULTING
Jamie Toth, Head of TMF Operations, DAIICHI SANKYO
Dinner Workshop Concludes
Conference Day One, AM Sessions | Wednesday, January 17, 2018 | Wednesday, January 17, 2018
Registration and Continental Breakfast Begin
Summit Chairpersons’ Opening Remarks
Marie-Christine Poisson-Carvajal, Head of TMF Operations, PFIZER
Karen Roy, Senior Vice President, Client Solutions, PHLEXGLOBAL
Jamie Toth, Head of TMF Operations, DAIICHI SANKYO
Focus on Quality by Conducting a Comprehensive TMF Review
  • Ensure that the TMF specifications account for the protocol and design specifications, study operational components and events
  • Improve TMF quality by analyzing the interrelationships of documents
  • Achieve risk-based QC through a holistic approach and a comprehensive review of documents individually and collectively to ensure content quality
  • Perform a comprehensive TMF Content Review to be inspection-ready by performing logical checks
  • Review documents as they related to each other, reconcile filing/indexing issues and identify gaps
  • Improve TMF quality by analyzing the systemic connections of your study to your TMF
Marie-Christine Poisson-Carvajal, Head of TMF Operations, PFIZER
Survey and Comprehend Essential Considerations of Accurate Resourcing for eTMF
  • Address issues concerning resource and budget planning when moving from a paper to eTMF
  • Know the methodology for resourcing planning and allocation
  • Optimize current resources and talent
  • Articulate the unexpected financial benefits of an eTMF implementation
  • Study challenges and benefit from lessons learned in budget projections
  • Hone in on required metrics for optimal planning
Sharon Ames, Director, Client Solutions, PHLEXGLOBAL
Janice Fletcher, Senior TMF Project Manager, RHO
Networking Break
Take a Deep Dive Into Effective TMF Collaboration and Metrics Utilization
  • Review industry direction and trends with TMF over the past year

  • Discuss innovative methods and strategies that have been deployed when sponsors outsource to CROs
  • Understand progress with TMF metrics utilization and opportunities that remain
  • Share practical case studies of life sciences companies that are transforming their TMF operating models
Jason Methia, VP, Vault Clinical, Enterprise, VEEVA SYSTEMS
Ensure GCP and Harmonization by Bringing Your TMF In-House
  • Discover why this is a growing trend and the circumstances that make this advantageous
  • Discuss case examples of migrations would take place
  • Avoid non-noncompliance issues and through QC
  • Learn what you should do when you think you are done
  • Discuss site oversight and management considerations
  • Identify threats to compliance and data integrity
  • Look at what happens to eTMF/eTMF data in a third-party system and how do you extract artifacts and emails
Jackie Morrill, Director of Clinical Operations, LMK CLINICAL RESEARCH CONSULTING
Conference Day One, PM Sessions | Wednesday, January 17, 2018 | Wednesday, January 17, 2018
eTMF Implementation
Metrics and Tools
Case Study Survey the Triumphs and Challenges of a Large-Scale eTMF Implementation on a Short Timeline
  • Glean lessons from GSK's experience transitioning to the TMF Reference Model
  • Study strategy for R&D-wide implementation from leveraging early adopters to full rollout
  • Look at governance best practices and processes and avoid pitfalls
  • Discuss impediments for implementation and the tactical ways that GSK coped with them
  • Aspire for continuous improvement and sustainability
Mike Czaplicki, Clinical Documentation Operations Manager, GSK
Oversee and Manage Vendors to Ensure Inspection Readiness With Standard Metrics
  • Engage vendors and internal stakeholders to ensure inspection readiness
  • Manage vendor/stakeholder performance and process improvement
  • Improve collaboration using strategic standards and KPIs
  • Align objectives, strategy and relationships
Wendy Kelly, Manager, Global Development, SUNOVION
Transition Time
Improve Your TMF Process by Creating a Collaborative Culture That Empowers Teams
  • Leverage the experience of your team on the ground to identify priority improvements
  • Invest in your team to build commitment and improve TMF and inspection-readiness expertise
  • Reward individual and team accomplishments with meaningful project and process ownership
  • Promote a culture of interdependence and shared success while driving improvement across the clinical study life cycle
Eric Rubinson, Associate Director, R&D Consulting, PARAGON
Panel Discussion Establish Milestones for Piloting, Implementing and Executing a TMF System
  • Address eTMF scope and define gradations of eTMF and TMF maturity
  • Implement a pilot and ramp up phases while having a parallel paper and electronic version of the TMF
  • Discuss strategies for propelling your organization along the TMF continuum
  • Leverage industry benchmarks to drive process improvement

JP Miceli, Associate Director, Clinical Document Management, SHIRE


Evelin Baez, Clinical Document Management Specialist, CR BARD
Alex Markiel, Director, Clinical Operations, Head of Clinical Document Control, PHARMACYCLICS
Jennifer J. Poulakos, Director, Development Quality Assurance, AGENSYS
Shannon A. Simpson, IRB and Clinical Trials Documentation Specialist, PATH’S CENTER FOR VACCINE INNOVATION AND ACCESS
Karen Whitson, Assistant Director, Clinical Documentation Center, ABBVIE

Networking Break
Case Study Globalize eTMF Management
  • Discuss ​Eisai’s experience of implementing eTMF globally, in particular, in Japan
  • Compare and contrast the regional processes, adaptations and design of two eTMF operating models
  • Understand the differences in document collection and filing
  • Utilize the TMF Reference Model when developing a filing guide for Japan eTMF
  • Engage internal cross​-​functional teams to design, plan and execute an eTMF
Wendy Trimboli, Head of TMF Process Management and QC, EISAI
Case Study Meet Business Imperatives and eTMF Requirements by Configuring an eTMF System
  • Ensure that functional leads perceive and can use the TMF as an ongoing study tool
  • Account for business process needs through a suitable eTMF configuration
  • Study how eTMF at Regeneron is used as an ongoing study tool
Jason Weinstein, Associate Manager eTMF, REGENERON PHARMACEUTICALS INC.
Transition Time
Panel Adapt for Automation and Integration of the Next Generation of eTMFs
  • Prepare for TMF processes and system changes resulting from automation and integration
  • Study the trajectory of eTMF solutions and features to better understand necessary capabilities
  • Learn where to automate and integrate TMF systems/processes to improve timeliness and quality
  • Examine the impact of user design and address particular impediments
  • Simplify TMF artifact management through master data management
  • Explore various testimonials of TMF automation and integration

​James Farley, Director of Data Management and Programming, VTV Therapeutics


Frederico Braga, Principal, Platform Strategy and Adoption, MEDIDATA
Alex Markiel, Director, Clinical Operations, Head of Clinical Document Control, PHARMACYCLICS
Kelley Robinson, Repository Management Lead, Content Management and Authoring, PFIZER
Stephanie Viscomi, Associate Director, TMF, Clinical Training and Records Management, IMMUNOGEN

Panel Use Metrics and Benchmarks to Improve TMF Management
  • Conduct and orchestrate activities by leveraging how quality metrics
  • Leverage metrics to improve the process and engage CROs’ investment
  • Identify the right set of TMF metrics for your organization
  • Study the impact of stakeholder oversight and metrics when a TMF is managed by a sponsor versus a CRO
  • Compare challenges faced by smaller and larger companies

Jamie Toth, Head of TMF Operations, DAIICHI SANKYO


Brenda Brown, TMF Operations Lead, PFIZER
Allison Grosik, Senior Associate, TMF Management and Compliance, EISAI
Dawn M. Niccum, Director, Quality Assurance, INSEPTION GROUP
Tyler Prater, Clinical Trial Project Manager, ELI LILLY AND COMPANY
Fabio Rodrigues, Head of eTMF in LATAM and Clinical Operations Manager, BOEHRINGER INGELHEIM BRAZIL

Networking Reception
Day One Concludes
Conference Day Two, AM Sessions | Thursday, January 18, 2018 | Thursday, January 18, 2018
Registration and Continental Breakfast Begin
Co-Chair’s Recap Day One
Karen Roy, Senior Vice President, Client Solutions, PHLEXGLOBAL
Co-Chair’s Recap Day One
Marie-Christine Poisson-Carvajal, Head of TMF Operations, PFIZER
Co-Chair’s Recap Day One
Jamie Toth, Head of TMF Operations, DAIICHI SANKYO
Use Software Development Methodology to Maintain Quality in Your TMF
  • Apply lessons from software development methodologies (e.g., agile, lean software) to address TMF concerns
    • Adherence to TMF standards
    • Audit readiness
    • Process improvement
Terri Baker, Director, Professional Services, WINGSPAN TECHNOLOGY
Pass Your Inspections With a Risk-Based Approach in Accord With Trends and Anticipated Ramifications of ICH E6(R2)
  • Discuss MHRA's emphasis on conducting a risk-based analysis and study case examples
  • Survey and compare inspections from different regulatory authorities
  • Hear assorted first-hand experiences of sponsors to uncover common pitfalls
  • Discuss foci of inspectors and what they inspected and didn't inspect to determine compliance
  • Comply with ICH E6(R2) changes by adapting your risk-based tools and methods
  • Effect a risk-based approach to inspection readiness with tried and tested strategies
Grace Crawford, VP Clinical Quality and Compliance, MedImmune
Steve Whittaker, Executive Director, THE AVOCA QUALITY CONSORTIUM; Senior Consultant, THE AVOCA GROUP
Ensure Compliance With Proof of Oversight Requirements of GCP R2 by Selecting CROs by Evaluating Their Abilities and Discerning Their Suitability
  • Determine telling and relevant measurements to assess risk to Quality and Compliance​
  • Evaluate customer service aptitude by asking the right questions and scrutinizing answers
  • Distinguish red flags from deal breakers and discuss suitable precautions/ remedies
  • Consider risk factors when selecting a specific CRO
  • Determine effective metrics for evaluating the performance of the supplier
Lori J. Ridge, Clinical Project Associate Lead, Critical Document Analyst, eTMF Oversight Expert, MYLAN
Transition Time
Case Study Maintain Consistency Through M&A and Other Transitions
  • Recognize the possible impact of changes (e.g., M&A, leadership change, etc.) on quality
  • Create and implement comprehensive transition plans
  • Manage internal organization and policy changes
Brenda Brown, TMF Operations Lead, PFIZER
Ensure Inspection Readiness From the Beginning
  • Build and develop a team according to trial demands of the trail and third-party needs
  • Determine set checkpoints for the life cycle of the trial
  • Set up your TMF before the start of the trial
  • Establish clear expectations and providing adequate and impactful coaching and training
  • Examine common impediments to inspection readiness resulting from M&A
Jennifer Christofferson, Director, Global Site Operations, Program Management, ALLERGAN
Determine the Degree of Correlation or Dissociation of ​eSignatures ​to Essential Documents
  • Discuss the trends in the ​adoption and​ use of eSignatures by ​sponsors, CROs and​ ​​sites
  • Prepare for​ ​inspection of eSignatures and ​​dissect ​the technology that enables them
  • Examine the impact of new regulations and guidance on essential documents and regulated content management systems
  • Discover and compare variations in technology models, from the Chevy to the Cadillac
Betsy Fallen, Special Topics Consultant, SAFE-BIOPHARMA ASSOCIATION
Networking Break
Set up a Successful TMF Staff
  • Rank characteristics to search for when hiring a Document Specialist.
  • Institute an Individual Development Plan program from beginning/training to autonomy
  • Harmonize TMF staff using Six Sigma tool (MSA)
  • TMF Staff management: motivating your staff
  • Discuss advantages and disadvantages of regional staff or local staff
Catharine Espanhol, LATAM eTMF Coordinator, BOEHRINGER INGELHEIM
Fabio Rodrigues, Head of eTMF in LATAM and Clinical Operations Manager, BOEHRINGER INGELHEIM BRAZIL
Overcome Pain Points and Maintain Inspection Readiness Through Document Processing Improvements, Collection Oversight and Rolling Audits
  • Survey TMF document collection trends
  • Effect continuous collection improvements through KPI’s
  • Conduct rolling audit review of your eTMF
  • Achieve collaboration with your TMF partners
  • Discuss tactics for document mitigation
James Peters, Director of Professional Services, DATA REDUCTION SYSTEMS CORPORATION
Case Study Work Effectively With CROs to Create a Unified TMF Process and Maintain Inspection Readiness
  • Discuss Alkermes’ consistency-driven oversight strategy for CROs  and its impact on consistency
  • Institute avenues for two-way communication and collaboration among internal functions and CROs
  • Communicate expectations and support internal and external stakeholders
  • Improve internal and external processes through training and support
  • Discuss the lessons learned from working with a broad array of CROs of disparate cultures and needs​
Kate Santoro, Clinical Trial Manager, Clinical Systems and Documentation, ALKERMES
Transition Time
Case Study Holistic Approach for Achieving Quality — Inspection-Ready TMFs
  • Discuss the impact of ICH E6 (R2) on TMF quality and quantity
  • Identify strategies to evaluate and mitigate TMF compliance risks
  • Establish quality standards, metrics and tools to keep TMFs accurate and current
  • Identify and limit risk in accordance with common inspection findings
  • Minimize risk through effective change management and education
Jennifer J. Poulakos, Director, Development Quality Assurance, AGENSYS
Effect eTMF Quality by Providing Essential Training and Support
  • Communicate, clarify, and uphold expectations for sponsor and CRO eTMF user
  • Conduct performance-based training simulations in person and remotely
  • Explore metrics for user performance assessments and thresholds for interventions or additional training
  • Survey various training tools and how they are customized
  • Execute validations and make necessary changes to script
  • Partner with HR to ensure that suitable candidates are selected based on informed criteria
Dina Antonacci, Clinical Training and Systems Manager, MALLINCKRODT
Case Study: Work Effectively on eTMF with a Strategic Partner CRO and Other CROs
  • Assess to determine whether to use your eTMF or the CRO’s eTMF
  • Master migrations beyond the transfer of files
  • Onboard and provide training for CRO staff
  • Collaborate by facilitating CRO processes
Martina Duevel, Systems Excellence Project Leader, BAYER PHARMACEUTICALS
Transition TIme
Achieve Business Success Beyond Inspection Readiness With an eTMF
  • Identify business processes and stakeholders who are impacted by eTMF
  • Devise eTMF architecture and operations to support business processes
  • Ensure that your eTMF architecture is eTMF is informed by user need by looking at possible engagement strategies for internal allies
  • Consider governance practices that ensure that eTMF is being analyzed and used for a strategic purpose
  • Educate and train staff to ensure adherence to what they may consider unnecessary complexity
Mathias Poensgen, Clinical Subject Matter Expert and Product Manager, ARISGLOBAL
Fortify Quality Control With an Inspection-Ready Mindset for TMF Quality Assurance
  • Highlight the instrumental practices for instilling and inspection-ready mindset
  • Solve problems in your organization via a multidisciplinary approach
  • Communicate QC reasoning and standards to ensure compliant document filing and maintenance sponsor companies
  • Provide comprehensive feedback to TMF users
  • Standardize metadata and examine your improved workflow
  • Use systems to their potential for efficient retrieval of inspection documents
Evelin Baez, Clinical Document Management Specialist, CR BARD
Advance Your Inspection Readiness With Analysis and Knowledge of Trends for Effective Oversight of CRO TMF Management
  • Evaluat​e​ of TMF for inspection readiness using customized tools
  • Extract​ ​metrics and prioritization of corrective action
  • Analyze to determine trends for process improvement and development
  • ​Consider the impact of new or pending regulations on TMF management
Mark Choe, TMF Quality Management and Inspection Readiness Consultant, DAIICHI SANKYO
Conference Day Two, PM Sessions | Thursday, January 18, 2018 | Thursday, January 18, 2018
TMF Sticker Program Drawing
*You must be present in the room to win
Prepare for a TMF Inspection — Follow the Trends and Remain Compliant
  • Assemble a representative team to establish protocols for when regulators arrive
  • Conduct mock inspections and audits with the right people and the right metrics
  • Convey expectations to stakeholders for inspection readiness
  • Select, engage and prepare CRO as partners in identifying and avoiding pitfalls
Laura Naranjo, TMF Operations, Clinical Development Operations Function, DAIICHI SANKYO
Panel Monitor eTMF Completeness and Compliance
  • Utilize metrics to ensure a high-quality TMF is maintained
  • Determine and communicate benchmarks for meeting GCP standards
  • Hear how various companies ensure eTMF quality
  • Leverage quality metrics to conduct/orchestrate activities
  • Compare and contrast the process and criteria for determining solutions
  • Use shared metrics for your eTMF to drive improve collaboration and help organizations gauge their own performance

Bryan Souder, Director, TMF Head, MERCK


Kelley Robinson, Repository Management Lead, Content Management and Authoring, PFIZER
Anne-Mette Varney, Principal Competency Development Specialist, NOVO NORDISK
Stephanie Viscomi, Associate Director, TMF, Clinical Training and Records Management, IMMUNOGEN

Networking Break
Panel Learn From Sites to Inform and Standardize Procedures, Provide Support and Develop Trainings
  • Provide empathetic/user-driven operations and protocols for site adherence and fidelity
  • Hear tactics for universal practices for the labeling and filing of documents
  • Prepare the site/sponsor teams along with the site/CRA/sponsor tools
  • ​Enhance the collection and management of Electronic Investigator Site Files (eISF) documents
  • Hear tactics and tips sites would recommend based on their stressors

Jennifer Christofferson, Director, Global Site Operations, Program Management, ALLERGAN


Amy Gunnett, Certified Clinical Research Coordinator, UNIVERSITY OF FLORIDA
Aryn Knight, Clinical Research Oversight Specialist, TEXAS HEALTH INSTITUTE
Amy Lounsbury, Manager, MINN. GASTROENTEROLOGY P.A.

Panel Coordinate to Collaborate: How CROs and Sites Can Become Partners
  • Vet CROs using poignant and objective criteria and evaluate their risk quotient and partner suitability
  • Determine telling and relevant measurements to assess risk to quality and compliance
  • Ascertain capability by adapting a rating system for cultural fit and aptitudes
  • Evaluate customer service aptitude by asking the right questions and scrutinizing answers
  • Explore the advantages of KPI-driven partnerships

Alex Markiel, Director, Clinical Operations, Head of Clinical Document Control, PHARMACYCLICS


Martina Duevel, Systems Excellence Project Leader, BAYER PHARMACEUTICALS
Joanne Malia, Associate Director, Clinical Documentation Management, REGENERON
Colleen Maude, Director, Trial Master File, MEDIMMUNE

Conference Concludes

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