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Courses

July 11, 2018, 9:00am – 5:00pm (choose one course)

  • TMF Foundations: Understand the Fundamentals and Challenges of the TMF, and the Regulations and Guidelines That Govern It
  • TMF Leadership: Steward Continuous Improvement Through Oversight and a Shared Culture of Quality With Internal and External Allies

July 12, 2018, 9:00am – 5:00pm (choose one course)

  • TMF Operations: Streamline Processes That Promote Inspection Readiness Throughout the Study Life Cycle
  • Electronic Records Management: Improve GCP for All Document Archiving and Records Management
TMF FOUNDATIONS | Wednesday, July 11, 2018
9:00AM
TMF FOUNDATIONS: Understand the Fundamentals and Challenges of the TMF, and the Regulations and Guidelines That Govern It

The TMF professional is a rapidly growing specialist role in the life science industry. With the advent of the 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. With this, there is a resultant need for TMF professional development opportunities starting 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 demonstrate compliance with ICH-GCP and local laws, regulations, and published guidances. However, TMF is not merely a repository -it’s 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 organization 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 are best to 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 key essential elements for success as outlined in regulations
  • Describe roles and approaches of TMF management-process stakeholders
  • Cite current laws, guidances and regulations governing TMF management
  • Name and define the elements that constitute a TMF and various forms that the documentation in the TMF can take
  • Identify the 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
  • Avoid TMF management pitfalls and troubleshooting strategies
  • Address common challenges of the TMF professional

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

Lead Instructors:
Lisa Mulcahy, Owner and Principal Consultant, MULCAHY CONSULTING

Instructors:
Kate Santoro, Clinical Trial Manager, ALKERMES
5:00PM
End of Conference
TMF LEADERSHIP | Wednesday, July 11, 2018
9:00AM
TMF LEADERSHIP: Steward Continuous Improvement Through a Oversight and a Shared Culture of Quality With Internal and External Allies

The onus to ensure Quality and Inspection Readiness is on TMF leaders. Within their purview are the creation and establishment of systems, the procurement and provisioning of resources, and stewardship of eTMF and paper-based systems. The state of a TMF is determined by a multitude of factors that include processes and information management practices that the TMF steward has agreed to. But the TMF Steward must synthesize an understanding of company culture, team-based leadership, staffing, operations, regulations, CRO partners and so forth into a comprehensive TMF executive strategy.

This course will enhance participants’ ability to analyze, assess and think strategically and lead partners and internal allies to autonomy. This course will look at the pros and cons of CRO partnerships according to case studies that spotlight nuanced needs, benefits and risks. Participants will be better prepared to develop and adapt plans throughout the clinical life cycle. Participants will assess a variety of situations including mergers and acquisitions, changing requirements, and other situations for their impact on Quality and Inspection Readiness and that may jeopardize fidelity to the TMF Management Plan.

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

  • Assess various partnership models to determine third-party partner strategy
  • Convey TMF executive strategy to constituencies in tailored communications
  • Build and manage cohesive cross-functional teams
  • Foster autonomy through staff selection and development
  • Vet CROs and other third parties based on their ability and suitability
  • Establish processes to conduct KPI-driven Quality reviews
  • Conduct collegial and constructive follow-up after a mock inspection
  • Tailor the TMF Management Plan and streamline processes throughout the study life cycle
  • Establish position titles, roles and responsibilities to support the management of TMF, GCP and partnerships
  • Establish milestones for piloting, implementing and executing eTMFs
  • Provide justification of resource allocation for a TMF management structure

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

Lead Instructors:
Bryan Souder, TMF Head, MERCK

Instructors:
Liz Farrell, Senior Manager, TMF, BIOGEN
Tamika Jackson, President, Corementum
Jennifer Maier, Associate Director, R&D Quality Compliance, ALEXION
Perry Steinberg, Regulated Content Management Product Leader, MEDIDATA
Stephanie Viscomi, Associate Director, Clinical Trial Office, IMMUNOGEN
5:00PM
End of Conference
TMF OPERATIONS | Thursday, July 12, 2018
9:00AM
TMF OPERATIONS: Streamline Processes That Promote Inspection Readiness Throughout the Study Life Cycle

Inspection Readiness is paramount to the work of the TMF professional. One way to ensure Inspection Readiness is to operationalize your TMF by developing a structure from study design to archiving. This allows for standards, operating procedures, content collection and Quality assurance practices to be put in place. Just as it is important to create a strong foundation in order to have an inspection-ready TMF, it is also critical to maintain oversight, evaluate QC and include processes that will foster continuous improvement.

Effectively planning, collecting and maintaining of clinical trial documents on an ongoing basis will significantly enhance the TMF life cycle. This course will illuminate efficient eTMF workflow process that when aligned with the way that trial documents are used and created. Participants will learn best practices for maximizing their processes from TMF from setup through closeout, to ensure they are inspection-ready on day one. Through the use of TMF metrics, stakeholders will be able to monitor and understand the health of the TMF in real time.

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
  • Adapt processes according to needs and threats over a study’s life cycle
  • Explain how the processes that stakeholders own impact Inspection Readiness
  • Reconcile filing/indexing issues and identify gaps by looking at the interrelationship of documents
  • Utilize technology to conduct Quality reviews
  • Articulate the impact of particular Quality controls to inspection-ready eTMF to stakeholders with different roles and functions
  • Conduct critical follow-up and follow-through after a mock inspection to improve GCP
  • Utilize technology strategically to improve your process and ensure alignment with your eTMF system.
  • Cite global guidances, laws and regulations that govern TMF
  • Conduct a Quality review using customized tools and methods
  • Improve collaboration with third parties by communicating well-defined expectations of sponsor and vendor

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

Lead Instructors:
Supriya Shoroff, Associate Director, TMF, SAGE THERAPEUTICS

Instructors:
Roberta Alton, Global Director, Clinical Operations, HALOZYME THERAPEUTICS
Donna Dorozinsky, President, JUST IN TIME GCP
Renee Fate, Director, Clinical Records Management, ALLERGAN
5:00PM
End of Conference
ELECTRONIC RECORDS MANAGEMENT | Thursday, July 12, 2018
9:00AM
ELECTRONIC RECORDS MANAGEMENT: Improve GCP for All Document Archiving and Records Management

While the purview of professionals who are responsible for electronic records management (which includes both paper and electronic trial master files) remains constant, their work is in a state of flux. New and emerging tools, technologies, regulations, trends on an industrywide scale are cause for perpetual consternation. The challenges of management are further amplified by company restructuring, mergers, acquisitions and changes in partnerships in the face of limited resources.

This course covers all facets of electronic records management. It will provide practical training and guidance for managing electronic records in regulated business systems. Participants will learn applicable regulatory requirements and implications of each specific requirement to their work. This course will spotlight particular challenges and solutions for managing electronic record life cycles and archives.

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

  • Cite GxP regulations, legislation and guidance documents
  • Know the spectrum of file formats and types of storage media
  • Ensure that data integrity requirements are met
  • Examine the impact of new regulations and guidance on essential documents and regulated content management systems
  • Vet record-keeping tools based on capability and suitability
  • Think strategically about digital preservation and retention
  • Establish universal practices for the labeling and filing of documents
  • Reconcile filing/indexing issues and identify gaps
  • Extract artifacts, emails and data in a third-party eTMF system

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

Lead Instructors:
Joanne Malia, Associate Director, Clinical Documentation Management, REGENERON
Jamie Toth, Head of TMF Operations, DAIICHI SANKYO; Secretary Health Sciences Records & Archives Association (HSRAA)

Instructors:
Laura Forcade, Clinical Trial Master File Specialist, ALEXION
5:00PM
End of Conference

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