Agenda

Choose one course per day

TMF FOUNDATIONS | Monday, 18 March 2019
9:00-17:00 TMF FOUNDATIONS: Understand TMF Fundamentals, Challenges and Regulations and Explore TMF Management Best Practices

Instructors:
  • Robin Farmer, Associate Director, Document Control and Training, DYNAVAX TECHNOLOGIES
  • susan homminga, Senior Manager of Process Quality, Clinical Medical Quality, glaxosmithkline
  • Tracey McCulloch, Head TMF Operational Excellence, Novartis
  • CLAUDIA PANITZ, Head eDMS Centre of Excellence/Regulatory Readiness, NOVARTIS

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.

INTEROPERABILITY AND CROSS-FUNCTIONAL INTEGRATION | Monday, 18 March 2019
9:00-17:00 INTEROPERABILITY AND CROSS-FUNCTIONAL INTEGRATION: Improve Inspection Readiness Through Enhanced Processes, Systems’ Alignment and QCs

Lead Instructor: MARTINA DUEVEL, Systems Excellence Project Leader, BAYER
Instructors:
  • cristoph gerdts, IT Business Partner Clinical, Bayer Business Services GmbH / Bayer AG
  • EDITH TAPIE, Document Management Expert, NOVARTIS
  • ANNE-METTE VARNEY, Principal Competency Development Specialist, NOVO NORDISK

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.

TMF MANAGEMENT AND COLLABORATION | Tuesday, 19 March 2019
9:00-17:00 TMF MANAGEMENT AND COLLABORATION: Bolster Quality Through Sound Governance, Oversight, Metrics and KPIs, and Technology

Lead Instructor: Martin Hausten, Head of Global Documentation Quality Centre EU, BOEHRINGER INGELHEIM
Instructors:
  • Kristen Bretzius, Document Center Manager, PSI CRO
  • Andreas Järemo, Associate Director Enablement, TMF Global Lead, ASTRAZENECA
  • Tim Rafferty, TMF Metrics and Data Quality Manager, ROCHE

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.

ELECTRONIC RECORDS MANAGEMENT | Tuesday, 19 March 2019
9:00-17:00 ELECTRONIC RECORDS MANAGEMENT: Meet Regulatory Requirements for Archiving and Management of Electronic Records

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

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.

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