Agenda

TMF FOUNDATIONS | Monday, March 18, 2019
TMF FOUNDATIONS: Understand the Fundamentals and Challenges of the TMF and the Regulations and Guidelines That Govern It

The TMF professional has adapted from a CRA type role to a specialised role in the life science industry. With the rapid growth and necessity for TMF professional, an increasing number of new hires or department transfers are coming into the field in need of essential instruction to quickly improve their proficiency and more productivity. As a result of this trend, there arises a need for TMF professional development opportunities beginning with the very basics. This is especially true given the high rate of change in the industry affecting the daily work associated with the management of the TMF (e.g., requirements for inspection readiness on an ongoing basis, electronic systems managing the TMF, updated guidances, regulations, etc.). It is important to employees and employers that all TMF professionals understand foundational concepts and requirements for the management of the TMF.

TMF documentation is a critical facet of a clinical trial and demonstrates compliance with ICH-GCP and local laws, regulations, and published guidances. However, TMF is not merely a repository; it is a living source of content and documentation that when done right, managed holistically and contemporaneously, and used wisely by the clinical study team can be an asset for Quality and clinical trial oversight.

This course will cover TMF fundamentals and defining characteristics of paper-based TMFs and electronic TMF (eTMF) systems. It will highlight the published regulations and guidances that drive the expectations for its management. The course will outline the essential elements of a TMF and introduce TMF Reference Model — the standard blueprint for the content and organisation of the TMF, including nomenclature and structure. Participants will look at processes for management including expectations for Quality checks for maintaining an inspection-ready TMF. Participants will learn who the stakeholders of the TMF are and what process supports should be in place to ensure fidelity of the TMF management processes.

Upon completion of this course, participants will know or be able to:
  • List the fundamentals of the TMF management process
  • Elucidate essential elements for success as outlined in regulations
  • Describe roles and approaches of TMF management process stakeholders
  • Cite global regulations and guidances that govern TMF management
  • Name and define the elements that constitute a TMF and various forms that the documentation in the TMF can take
  • Identify unique challenges of the management of the TMF, which is compounded by various functions that contribute to it
  • Expound strategies for relating the requirements for management to various TMF stakeholders of the study team
  • Outline the suite of TMF management process-related documents and elucidate the importance of each
  • Provide definitions for expectations for TMF completeness and strategies for monitoring compliance
*This course includes a continental breakfast at 8AM, two networking breaks, and lunch.

Lead Instructor: Wendy Trimboli, Director, Head of TMF Management and Compliance, EISAI
Instructors: Claudia Panitz, Head eDMS Centre of Excellence/Regulatory Readiness, NOVARTIS
INTEROPERABILITY AND CROSS-FUNCTIONAL INTEGRATION | Monday, March 18, 2019
9:00AM
INTEROPERABILITY AND CROSS-FUNCTIONAL INTEGRATION: Improve Inspection Readiness Through Enhanced Processes, Systems’ Alignment and QCs

With the advent of technology comes the impetus for integration. Gone are the days of compartmentalised functions within and among organisations. Compliance with a complex global set of guidelines and regulations necessitates integration of functions. Thinking and acting strategically about processes and workflows is essential for efficient interoperability.

This course will elucidate how systems — electronic and professional units — relate to one another. Participants will survey the number of systems that use or contribute to eTMF content and explore the essential requirements for machine-to-machine exchange of TMF content. Attendees will know the challenges of inspections and oversight of multiple electronic systems and disparate users, and what Quality Controlsshould be appropriate.

This course will highlight efficient eTMF workflow processes alignment with the way that trial documents are used and created. Participants will learn best practices for maximising their processes from TMF from setup through closeout, to ensure they are inspection-ready from day one.

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

  • Align the eTMF workflow process with the way documents are used, created, collected, sorted and used to facilitate study management
  • Command electronic systems and streamline processes to support the ability to work across-functions to work with vendors
  • Adjust your processes to maximise benefits and mitigate risks of machine learning and AI
  • Understand the implications of proposed TMF Exchange Mechanism for TMF automation
  • Cite global regulations and define data integrity expectations in regards to TMF
  • Compare requirements and document types related to GXP and GCP and see how they relate to the DIA Reference Model
  • Reconcile filing/indexing issues and identify gaps by looking at the interrelationship of documents
  • Adapt your staffing, training and support based on changes in the required skill sets
  • Implement cross-functional Quality review and inspection preparation
  • Build internal teams representing multiple functions to plan implementation and remediation

*This course includes a continental breakfast at 8AM, two networking breaks, and lunch.

Lead Instructor: Martina Duevel, Systems Excellence Project Leader, BAYER
Instructors:
  • Edith Tapie, Document Management Expert, NOVARTIS
  • Anne-Mette Varney, Principal Competency Development Specialist, NOVO NORDISK
TMF MANAGEMENT AND COLLABORATION | Tuesday, March 19, 2019
9:00AM
TMF MANAGEMENT AND COLLABORATION: Bolster Quality Through Sound Governance, Oversight, Metrics and KPIs, and Technology

This course focuses on the relationships of TMF operations with TMF internal functions and external allies. Whereas yesterday’s Interoperability and Integration course explored how processes beget interoperability, this course looks at how technology can be used to enhance all manner of processes — decision-making, QC, analysis, oversight, monitoring, workflows and so forth.

Choice data management entails preserving data integrity and measuring the right things with the right metrics. This course will elucidate practices that capitalise on the judicious use of technology, metrics and automation for monitoring the health of the TMF in real time.

Internal and external collaborations bolstered by Quality Management System are prerequisites for amplifying the impact of technology and data for continuous improvement. Quality and efficiency also call for a meld of cooperation and collaboration between and among functions external partnerships. Participants of this course will develop their change management savvy and governance acuity. The significance and complexity of the sponsor-CRO relationship continue to grow and evolve. At the same time, the cross-functions are becoming more interdependent as a result of its expanding application to augment Quality oversight and business functions.

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

  • Customise KPIs and other metrics to reflect meaningful and actionable outcomes, reveal risk factors and facilitate solutions
  • Build and administrate cross-functional committees for governance and implementation
  • Identify various types and locations of data and how it can be retrieved
  • Discuss the pitfalls and drawbacks of automation and technology
  • Apply eTMF to oversight and monitoring trials with internal and external allies
  • Articulate and expectations for sponsor and CRO organisations and for individual users
  • Use audits for QC and oversight tools, and conduct improvement-driven follow-up to improve GCP
  • Conduct Quality reviews using KPIs that account for a CRO’s own assessment system
  • Advocate for C-level engagement and investment by justifying resource allocation for a TMF management structure
  • Comply with ICH E6(R2) changes by adapting risk-approaches with tailored tools and methods

*This course includes a continental breakfast at 8AM, two networking breaks, and lunch.

Lead Instructor: Martin Hausten, Head of Global Documentation Quality Centre EU, BOEHRINGER INGELHEIM
Instructors:
  • Kristen Bretzius, Document Center Manager, PSI CRO
  • Andreas Järemo, TMF Global Head, ASTRAZENECA
  • Tim Rafferty, TMF Metrics and Data Quality Manager, ROCHE
ELECTRONIC RECORDS MANAGEMENT | Tuesday, March 19, 2019
9:00AM
ELECTRONIC RECORDS MANAGEMENT: Meet Regulatory Requirements for Archiving and Management of Electronic Records

The environmental conditions that professionals who are charged with electronic record management must weather could not be more dynamic — evolving system capabilities, emerging technologies, increasing and often conflicting regulations, companies transitioning, and so forth. Limited resources in terms of investment and use of external and internal allies magnify the challenges they face.

This course covers a multitude of facets related to the management of electronic TMF records that professionals and stakeholders need to know and be able to do in order to ensure compliance with GCP, other regulations, and to adopt optimum systems and processes. Participants will learn how to navigate the universal and niche expectations of various regulatory agencies. This course will spotlight particular challenges and solutions for managing TMF documents, artefacts and data throughout the trial life cycle from before startup to archiving.

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

  • Know the spectrum of file formats and types of storage media
  • Establish universal practices for the classification and filing of documents
  • Cite GCP global regulations and guidances governing documents
  • Ensure that data integrity requirements are met
  • Examine the impact of new regulations, guidance and key opinion leader thinking on essential documents
  • Vet record-keeping tools for suitability in the immediate and distant futures
  • Extract artifacts, emails and data in a third-party eTMF system
  • Identify effective procedures, practices and rules for digital preservation and retention
  • Facilitate long-term access, integrity, and readability of archived records across systems
  • Prepare for inspections with particular attention to the Regulatory archive environment (GLP, GCP, GMP)
  • Adapt your management and archiving strategy based on inspection trends
  • Understand the implications of and available resources for the proposed TMF Exchange Mechanism for TMF automation

*This course includes a continental breakfast at 8AM, two networking breaks, and lunch.

Lead Instructor: Eldin Rammell, Director, HEALTH SCIENCES RECORDS & ARCHIVES ASSOCIATION
Instructor: Jamie Toth, Head of TMF Operations, DAIICHI SANKYO; Secretary, HSRAA

18 March 2019, 9:00 – 17:00 (choose one course)

  • TMF FOUNDATIONS: Understand the Fundamentals and Challenges of the TMF and the Regulations and Guidelines That Govern It
  • INTEROPERABILITY AND CROSS-FUNCTIONAL INTEGRATION: Improve Inspection Readiness Through Enhanced Processes, Systems’ Alignment and QCs

19 March 2019, 9:00 – 17:00 (choose one course)

  • TMF MANAGEMENT AND COLLABORATION: Bolster Quality Through Sound Governance, Oversight, Metrics and KPIs, and Technology
  • ELECTRONIC RECORDS MANAGEMENT: Meet Regulatory Requirements for Archiving and Management of Electronic Records

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