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Monday, November 2
 

9:00am EST

Chairperson’s Opening Remarks
Speakers
avatar for Jamie Marie Toth, CPM, MS

Jamie Marie Toth, CPM, MS

Senior Director, Clinical Systems & Records, Global Clinical Operations & Planning, Daiichi Sankyo, Inc
Jamie Marie Toth, Senior Director Clinical Systems & Records at Daiichi Sankyo Inc, USA.Ms. Toth has been with Daiichi Sankyo, Inc. since 2016, and is the business owner for the eTMF system, the SNL IB solution, and the CTMS system. Her department oversees TMF Operations, clinical... Read More →
avatar for Karen Roy

Karen Roy

Chief Strategy Officer, Phlexglobal
Karen Roy has been responsible for the development of the TMF business at Phlexglobal since 2007, with a focus on creating solutions for our Clients’ TMF challenges. She started in Business Development, moving to Client Solutions, and now her focus is on strategy. In her role as... Read More →
avatar for Marie-Christine Poisson-Carvajal

Marie-Christine Poisson-Carvajal

Head of TMF and Registry, Pfizer
Marie-Christine is the Head of TMF & Registry Operations and the TMF Business Process Owner at Pfizer. She is responsible for developing and executing strategy for continuous TMF quality and efficiency improvements, driving execution and performance data for all TMF roles and activities... Read More →
avatar for Wendy Beeby

Wendy Beeby

Director, Clinical Document Management and Trial Support, Takeda Pharmaceuticals
Wendy Beeby is Director of Clinical Document Management and Inspection Readiness at Takeda, responsible for the strategic direction of clinical document management and working in collaboration with functional leads to implement effective inspection readiness and support plans.  With... Read More →


Monday November 2, 2020 9:00am - 9:15am EST

9:15am EST

How to Avoid The Meaningless Figures – Considerations for TMF Metrics
  • Start simply
  • Adjust and evolve your metrics
  • Identify and act on root causes of poor results

Speakers
avatar for Chris Jones

Chris Jones

Interim Head - Clinical Documentation, RD Clinical Operations, GlaxoSmithKline
Chris has worked in Pharma for over 25 years, initially in a variety of roles focussed on archiving and records management, before transitioning to working with TMF in 2017. His TMF experiences since then have included governance, end user support, process improvement, data migration... Read More →


Monday November 2, 2020 9:15am - 9:45am EST

9:50am EST

The Push for Full Content Management within the eTMF System
  • Leveraging content authoring, review, and signature capabilities to assist during COVID-19
  • Reducing document authoring cycle time
  • Enhancing cross-functional collaboration

Speakers
avatar for Laura Naranjo, M.S.J

Laura Naranjo, M.S.J

Associate Director, TMF Operations, Daiichi Sankyo
After working for the federal government, Laura made the move to pharma and has been working in TMF since 2009. She has worked on both the sponsor and vendor sides throughout her career and joined Daiichi Sankyo TMF Operations in 2016. Laura holds a passion for inspection readiness... Read More →


Monday November 2, 2020 9:50am - 10:20am EST

10:25am EST

TMF Reference Model: The why, who, how and where to!
  • A brief history of the TMF RM
  • Overview of version 3.2 (Release November 2020)
  • Open Panel discussion to ask any questions you want to the Steering Committee

Moderators
avatar for Karen Roy

Karen Roy

Chief Strategy Officer, Phlexglobal
Karen Roy has been responsible for the development of the TMF business at Phlexglobal since 2007, with a focus on creating solutions for our Clients’ TMF challenges. She started in Business Development, moving to Client Solutions, and now her focus is on strategy. In her role as... Read More →

Speakers
avatar for Lisa D.  Mulcahy, B.S.

Lisa D. Mulcahy, B.S.

Owner, Principal Consultant, Mulcahy Consulting, LLC
Lisa has 29+ year career in the biopharmaceutical R&D industry, in Clinical Operations, Quality Management, and since 2007 as an independent consultant focusing solely on the TMF management process. She assists clients with improvement of their current state, set up and use of eTMF... Read More →
avatar for Jamie Marie Toth, CPM, MS

Jamie Marie Toth, CPM, MS

Senior Director, Clinical Systems & Records, Global Clinical Operations & Planning, Daiichi Sankyo, Inc
Jamie Marie Toth, Senior Director Clinical Systems & Records at Daiichi Sankyo Inc, USA.Ms. Toth has been with Daiichi Sankyo, Inc. since 2016, and is the business owner for the eTMF system, the SNL IB solution, and the CTMS system. Her department oversees TMF Operations, clinical... Read More →
avatar for Marie-Christine Poisson-Carvajal

Marie-Christine Poisson-Carvajal

Head of TMF and Registry, Pfizer
Marie-Christine is the Head of TMF & Registry Operations and the TMF Business Process Owner at Pfizer. She is responsible for developing and executing strategy for continuous TMF quality and efficiency improvements, driving execution and performance data for all TMF roles and activities... Read More →
avatar for Wendy Trimboli

Wendy Trimboli

Senior Director Clinical Operations Process, Systems & Inspection Readiness, ACADIA Pharmaceuticals Inc.
Wendy has extensive pharma experience in clinical research and operations with expert knowledge of the end-to-end drug development process and current regulatory authority requirements in a global environment. She has facilitated cross-functional process improvement initiatives utilizing... Read More →


Monday November 2, 2020 10:25am - 11:10am EST

11:10am EST

Networking Break
Monday November 2, 2020 11:10am - 11:40am EST

11:40am EST

Inspection Best Practices for TMF Operations
    • Make your life easier by having a toolkit
    • Understand the scope of the inspection and assess gaps and areas at risk
    • Communicate and conduct a mock inspection with study team and partners

Speakers
avatar for Marie-Christine Poisson-Carvajal

Marie-Christine Poisson-Carvajal

Head of TMF and Registry, Pfizer
Marie-Christine is the Head of TMF & Registry Operations and the TMF Business Process Owner at Pfizer. She is responsible for developing and executing strategy for continuous TMF quality and efficiency improvements, driving execution and performance data for all TMF roles and activities... Read More →


Monday November 2, 2020 11:40am - 12:10pm EST

12:15pm EST

Secrets to a Healthy TMF
TMF Health is a frequently used term but is not clearly defined.  This session will focus on:
  • The different components that make up TMF Health
  • Assessing TMF Health
  • Monitoring TMF Health
  • Maintaining TMF Health

Speakers
avatar for LoriAnn M. Verna, RN, BSN

LoriAnn M. Verna, RN, BSN

Director, TMF Operations and Quality Assurance, Just in Time GCP
As Director of Quality and Compliance at Just in Time GCP, LoriAnn is responsible for overseeing all components of quality.  In addition, she is responsible for process development and improvement for the company and serves as an internal Subject Matter Expert for all things TMF... Read More →


Monday November 2, 2020 12:15pm - 12:45pm EST

12:50pm EST

Leverage Reports and Dashboards to Assess TMF health
  • Dive into records management culture
  • Review common document issues
  • Understand timely TMF health
  • Break down TMF Tools
  • Look to customizing reports and dashboard views



Speakers
avatar for Kent Johnson

Kent Johnson

Associate Director of Records Management, Arcus Biosciences
Kent started his career in the pharmaceutical industry in a tech support role for endpoint Clinical, supporting IXRS implementations. He eventually moved into a Project Management role working for several other IXRS vendors as well as a CRO in the IRT division. In 2013 Kent moved... Read More →


Monday November 2, 2020 12:50pm - 1:20pm EST

1:20pm EST

Chairperson's Closing Remarks
Speakers
avatar for Jamie Marie Toth, CPM, MS

Jamie Marie Toth, CPM, MS

Senior Director, Clinical Systems & Records, Global Clinical Operations & Planning, Daiichi Sankyo, Inc
Jamie Marie Toth, Senior Director Clinical Systems & Records at Daiichi Sankyo Inc, USA.Ms. Toth has been with Daiichi Sankyo, Inc. since 2016, and is the business owner for the eTMF system, the SNL IB solution, and the CTMS system. Her department oversees TMF Operations, clinical... Read More →
avatar for Karen Roy

Karen Roy

Chief Strategy Officer, Phlexglobal
Karen Roy has been responsible for the development of the TMF business at Phlexglobal since 2007, with a focus on creating solutions for our Clients’ TMF challenges. She started in Business Development, moving to Client Solutions, and now her focus is on strategy. In her role as... Read More →
avatar for Marie-Christine Poisson-Carvajal

Marie-Christine Poisson-Carvajal

Head of TMF and Registry, Pfizer
Marie-Christine is the Head of TMF & Registry Operations and the TMF Business Process Owner at Pfizer. She is responsible for developing and executing strategy for continuous TMF quality and efficiency improvements, driving execution and performance data for all TMF roles and activities... Read More →
avatar for Wendy Beeby

Wendy Beeby

Director, Clinical Document Management and Trial Support, Takeda Pharmaceuticals
Wendy Beeby is Director of Clinical Document Management and Inspection Readiness at Takeda, responsible for the strategic direction of clinical document management and working in collaboration with functional leads to implement effective inspection readiness and support plans.  With... Read More →


Monday November 2, 2020 1:20pm - 1:30pm EST

1:35pm EST

Zoom Rountable: TMF Health
Join Just in Time GCP at a roundtable where you can further discuss options for assessing and maintaining the health of your TMF.  Our featured speaker, LoriAnn Verna will be available to answer questions and leader a deeper detailed discussion.

Speakers
avatar for LoriAnn M. Verna, RN, BSN

LoriAnn M. Verna, RN, BSN

Director, TMF Operations and Quality Assurance, Just in Time GCP
As Director of Quality and Compliance at Just in Time GCP, LoriAnn is responsible for overseeing all components of quality.  In addition, she is responsible for process development and improvement for the company and serves as an internal Subject Matter Expert for all things TMF... Read More →


Monday November 2, 2020 1:35pm - 2:35pm EST
 
Tuesday, November 3
 

9:00am EST

Chairperson’s Opening Remarks
Speakers
avatar for Jamie Marie Toth, CPM, MS

Jamie Marie Toth, CPM, MS

Senior Director, Clinical Systems & Records, Global Clinical Operations & Planning, Daiichi Sankyo, Inc
Jamie Marie Toth, Senior Director Clinical Systems & Records at Daiichi Sankyo Inc, USA.Ms. Toth has been with Daiichi Sankyo, Inc. since 2016, and is the business owner for the eTMF system, the SNL IB solution, and the CTMS system. Her department oversees TMF Operations, clinical... Read More →
avatar for Karen Roy

Karen Roy

Chief Strategy Officer, Phlexglobal
Karen Roy has been responsible for the development of the TMF business at Phlexglobal since 2007, with a focus on creating solutions for our Clients’ TMF challenges. She started in Business Development, moving to Client Solutions, and now her focus is on strategy. In her role as... Read More →
avatar for Marie-Christine Poisson-Carvajal

Marie-Christine Poisson-Carvajal

Head of TMF and Registry, Pfizer
Marie-Christine is the Head of TMF & Registry Operations and the TMF Business Process Owner at Pfizer. She is responsible for developing and executing strategy for continuous TMF quality and efficiency improvements, driving execution and performance data for all TMF roles and activities... Read More →
avatar for Wendy Beeby

Wendy Beeby

Director, Clinical Document Management and Trial Support, Takeda Pharmaceuticals
Wendy Beeby is Director of Clinical Document Management and Inspection Readiness at Takeda, responsible for the strategic direction of clinical document management and working in collaboration with functional leads to implement effective inspection readiness and support plans.  With... Read More →


Tuesday November 3, 2020 9:00am - 9:10am EST

9:10am EST

Key Document Reviews- A Risk Based Approach to TMF QC
  • Understand the meaning of TMF Oversight
  • Leverage your eTMF system reports to assess “Key” Documents
  • Use identified gaps to understand the health of your TMF as managed by Sponsor or CRO

Speakers
avatar for Anusha Rameshbabu

Anusha Rameshbabu

Trial Master File (TMF) Process Specialist, Alexion Pharmaceuticals, Inc.
Anusha Rameshbabu is a TMF Process Specialist at Alexion in Boston, MA. Her role involves collaborating with TMF stakeholders throughout her organization to identify and address process gaps and oversee TMF activities across several clinical studies. As part of this role she has developed... Read More →
avatar for Stephanie Viscomi

Stephanie Viscomi

Associate Director, TMF Operations, Alexion Pharmaceuticals, Inc.
Innovation-minded and results-driven Clinical Research Document Management professional. Stephanie’s experience is in all stages of biopharmaceutical and medical device development ,early phase through post-approval and across multiple therapeutic areas. Broad-ranging skills in... Read More →


Tuesday November 3, 2020 9:10am - 9:40am EST

9:45am EST

Signposting: Navigating Sponsor Oversight
  • Take a journey through your studies and gain insights on how best to align relationships between documents and how your actions today can help to demonstrate your oversight processes and activities in your eTMF. 
  • Review pointed examples and best practices. 
  • Explore the concept of signposting and how this can support the assertion of good trial oversight down the road.

Speakers
avatar for Darshan Patel

Darshan Patel

Customer Success Manager, Global Delivery Services, IQVIA Technologies
Darshan Patel has over 6 years of clinical experience working across various therapeutic areas, with a strong background in TMF management and process development in a sponsor setting.


Tuesday November 3, 2020 9:45am - 10:15am EST

10:20am EST

Ownership of the TMF as a Central Repository
  • Challenges of a single repository
  • Challenges around ownership of the TMF
  • Areas of progress

Moderators
avatar for Barbara Hepworth-Jones

Barbara Hepworth-Jones

Director, Clinical Development Regulations and Advocacy, Quality & Risk Management, R&D Clinical Operations, GSK
Barbara Hepworth-Jones is Director of Quality and Risk Management at GSK. This includes ensuring GSK’s global processes, procedures and training meet current and future regulatory requirements and GCP, and supporting GCP inspection readiness. Barbara has a PhD from the University... Read More →

Speakers
avatar for Christa Lewiski

Christa Lewiski

Study File Manager (TMF Head), Seqirus
Christa Lewiski is TMF Head, Study File Manager at Seqirus for the last 2 years. She is responsible for Seqirus’s Veeva Vault TMF system and all TMF processes. She has over 18 years of experience in TMF/clinical document management within the biopharmaceutical industry.
avatar for Priya Chaturvedi, PhD.

Priya Chaturvedi, PhD.

VP, Clinical Quality Assurance, Eisai, Inc.
Priya Chaturvedi is currently the VP and Head of Global Clinical Quality Assurance at Eisai. Prior to joining, Eisai Inc., Priya served as Executive Director, Clinical Quality Assurance at Merck. Prior to Merck, Priya was at Pfizer in the Quality oversight roles in Clinical and Med... Read More →
avatar for Katrien Clinckx

Katrien Clinckx

Director, Head TMF Operations & Clinical Support, Galapagos
Clinical study experience since 2005, as CRA and study manager/lead in CRO & pharma companies. Since 2016, member of the Clinical Operations management team at Galapagos NV, a fast growing Biotech company. Lead the implementation of eTMF and TMF processes. Set-up and leading the TMF... Read More →


Tuesday November 3, 2020 10:20am - 11:05am EST

11:05am EST

Networking Break
Tuesday November 3, 2020 11:05am - 11:35am EST

11:35am EST

The Full Story – TMF Completeness
- Defining what TMF completeness really means
- Best practices and tips for TMF completeness

Speakers
avatar for Fiona MacKenzie

Fiona MacKenzie

Manager, TMF, Alnylam Pharmaceuticals
Fiona has been working in the TMF space for 10 years, in both sponsor and CRO environments. Fiona began her career conducting QC of paper files at INC Research (now Syneos), and during the shift from paper to eTMF has developed a passion for all things TMF, specifically process improvement... Read More →


Tuesday November 3, 2020 11:35am - 12:05pm EST

12:10pm EST

Brick by Brick: Building a Successful TMF Operations Department
In-house TMF Operations can be a challenge. In a conversational setting, learn how a growing company focused on their people, process, and technology to build a  successful department on a solid foundation that ensures continuous inspection readiness.

Speakers
avatar for Noeleen Valenzuela

Noeleen Valenzuela

Associate Director, TMF and Document Management, Alnylam UK Limited
I have 18+ years in pharma development ranging with roles in big pharma, CROs and vendors. I spent 4+ years of that time in pure TMF roles with a vendor working on TMF inspection readiness for 3 years and TMF quality for 1+ year. I am currently leading the TMF efforts at Alnylam... Read More →
avatar for Sholeh Ehdaivand

Sholeh Ehdaivand

President and CEO, LMK Clinical Research Consulting
Sholeh is an internationally known TMF Subject Matter Expert with over 20 years of experience in the Clinical Research Industry.  Her expertise and knowledge in all areas of study management, clinical trial operations and TMF document management processes have made her a leader and... Read More →


Tuesday November 3, 2020 12:10pm - 12:40pm EST

12:45pm EST

Your trial is done; now what? Quality Management in TMF Archiving
  • Compliance with regulations (FDA part 11, EU Annex 11, GDPR, HIPAA)
  • Cloud storage vs. off-line storage and short-term vs. long-term archiving
  • Best practices for completeness assessments and ensuring inspection readiness

Moderators
avatar for Courtney Wells

Courtney Wells

Vice President, Clinical Operations, Avadel Pharmaceuticals
Courtney Wells has over 20 years' experience in drug development and clinical operations in over 35 indications. She has directly contributed to three new drug approvals and executed pivotal trials for four additional programs that led to approvals. She served as Vice President- Operations... Read More →

Speakers
avatar for Eldin Rammell

Eldin Rammell

Head of Quality Assurance, Plexglobal
Eldin is employed with Phlexglobal as Head of Quality Assurance. Prior to joining Phlexglobal in early 2019, Eldin ran a successful independent records management consultancy (Rammell Consulting Ltd) for 15 years. This followed a 17-year career as an archivist and records manager... Read More →
avatar for Mallorie Sayre

Mallorie Sayre

eTMF Manager, Clinical Operations, Moderna
I started my career with the TMF 6 years ago as an intern while earning my Master of Science in Information Studies degree. More recently I was the Manager of Clinical Documentation at AveXis where I was able to build the TMF from the ground up. There I was able to implement the Veeva... Read More →
avatar for Krista Serratore

Krista Serratore

Team Lead, TMF Operations, Alimentiv Inc.
Krista began her career in TMF over 6 years ago after graduating from the Clinical Trials Management program at Western University in London, ON. At Alimentiv Krista has overseen Trial Master Files as a CRO and vendor from start-up through to transfer & archiving. Krista now leads... Read More →


Tuesday November 3, 2020 12:45pm - 1:30pm EST

1:30pm EST

Chairperson's Closing Remarks
Speakers
avatar for Jamie Marie Toth, CPM, MS

Jamie Marie Toth, CPM, MS

Senior Director, Clinical Systems & Records, Global Clinical Operations & Planning, Daiichi Sankyo, Inc
Jamie Marie Toth, Senior Director Clinical Systems & Records at Daiichi Sankyo Inc, USA.Ms. Toth has been with Daiichi Sankyo, Inc. since 2016, and is the business owner for the eTMF system, the SNL IB solution, and the CTMS system. Her department oversees TMF Operations, clinical... Read More →
avatar for Karen Roy

Karen Roy

Chief Strategy Officer, Phlexglobal
Karen Roy has been responsible for the development of the TMF business at Phlexglobal since 2007, with a focus on creating solutions for our Clients’ TMF challenges. She started in Business Development, moving to Client Solutions, and now her focus is on strategy. In her role as... Read More →
avatar for Marie-Christine Poisson-Carvajal

Marie-Christine Poisson-Carvajal

Head of TMF and Registry, Pfizer
Marie-Christine is the Head of TMF & Registry Operations and the TMF Business Process Owner at Pfizer. She is responsible for developing and executing strategy for continuous TMF quality and efficiency improvements, driving execution and performance data for all TMF roles and activities... Read More →
avatar for Wendy Beeby

Wendy Beeby

Director, Clinical Document Management and Trial Support, Takeda Pharmaceuticals
Wendy Beeby is Director of Clinical Document Management and Inspection Readiness at Takeda, responsible for the strategic direction of clinical document management and working in collaboration with functional leads to implement effective inspection readiness and support plans.  With... Read More →


Tuesday November 3, 2020 1:30pm - 1:40pm EST

1:45pm EST

Zoom Rountable: Building Blocks of TMF Operations
Speakers
avatar for Sholeh Ehdaivand

Sholeh Ehdaivand

President and CEO, LMK Clinical Research Consulting
Sholeh is an internationally known TMF Subject Matter Expert with over 20 years of experience in the Clinical Research Industry.  Her expertise and knowledge in all areas of study management, clinical trial operations and TMF document management processes have made her a leader and... Read More →


Tuesday November 3, 2020 1:45pm - 2:45pm EST
 
Wednesday, November 4
 

9:00am EST

Chairperson's Opening Remarks
Speakers
avatar for Jamie Marie Toth, CPM, MS

Jamie Marie Toth, CPM, MS

Senior Director, Clinical Systems & Records, Global Clinical Operations & Planning, Daiichi Sankyo, Inc
Jamie Marie Toth, Senior Director Clinical Systems & Records at Daiichi Sankyo Inc, USA.Ms. Toth has been with Daiichi Sankyo, Inc. since 2016, and is the business owner for the eTMF system, the SNL IB solution, and the CTMS system. Her department oversees TMF Operations, clinical... Read More →
avatar for Karen Roy

Karen Roy

Chief Strategy Officer, Phlexglobal
Karen Roy has been responsible for the development of the TMF business at Phlexglobal since 2007, with a focus on creating solutions for our Clients’ TMF challenges. She started in Business Development, moving to Client Solutions, and now her focus is on strategy. In her role as... Read More →
avatar for Marie-Christine Poisson-Carvajal

Marie-Christine Poisson-Carvajal

Head of TMF and Registry, Pfizer
Marie-Christine is the Head of TMF & Registry Operations and the TMF Business Process Owner at Pfizer. She is responsible for developing and executing strategy for continuous TMF quality and efficiency improvements, driving execution and performance data for all TMF roles and activities... Read More →
avatar for Wendy Beeby

Wendy Beeby

Director, Clinical Document Management and Trial Support, Takeda Pharmaceuticals
Wendy Beeby is Director of Clinical Document Management and Inspection Readiness at Takeda, responsible for the strategic direction of clinical document management and working in collaboration with functional leads to implement effective inspection readiness and support plans.  With... Read More →


Wednesday November 4, 2020 9:00am - 9:10am EST

9:10am EST

Possible Futures for Research
  • Changes in data collection
  • The Covid Response
  • The role of the citizen and the emergence of the ‘data donor’

Speakers
avatar for Mick Mullane

Mick Mullane

Innovation Lead, National Institute of Health Research (NIHR)
Mick, has worked in digital for over 25 years. Mick has a track record in delivering innovative solutions built on technology, from working with some of the first educational broadband and networks in the 1990’s, to early online and social learning systems in the 2000’s. pioneering... Read More →


Wednesday November 4, 2020 9:10am - 9:40am EST

9:45am EST

Practical Applications of Machine Learning for Clinical Document and TMF Automation
As sponsors and CROs continually improve their efficiency when running clinical trials, machine learning has multiple, specific, and valuable use cases. Attendees will hear about the following effective use cases:
  • Classification of documentation
  • Metadata extraction from documentation,
  • eTMF health assessment
These key areas involve the processing of thousands of pieces of data in addition to classic use cases for clinical outcome assessments, patient-reported outcomes, site quality, and patient enrollment.
Attendees will be guided on the practical use of these technologies. They will learn to determine the use cases that are most relevant and applicable in clinical operations. Finally, the session will describe some examples of how these technologies are being used and will be used in the future.

Speakers
avatar for Jay Smith

Jay Smith

Head of Product, Trial Interactive, TransPerfect
Jay is responsible for managing the creation and design of product features and new capabilities for Trial Interactive. Jay brings over 28 years of product management, consulting, and engineering experience across verticals such as life sciences, enterprise software, healthcare, government... Read More →


Wednesday November 4, 2020 9:45am - 10:15am EST

10:20am EST

Solving the Email Problem: Automating Correspondence Classification in the TMF
  • Email correspondence represents one of the greatest challenges to building a complete Trial Master File.
  • This is a serious problem facing clinical trial sponsors, as it is difficult to capture all email correspondence and to classify it properly within the TMF.
  • In this session, we will discuss this problem from a compliance perspective and explore the TMF Reference Models correspondence guidance.
  • The session will also feature a case study from Chiesi, discussing the problems they were facing and how a pilot study using Phlexglobal Artificial Intelligence helped with eMail classification.

Speakers
avatar for Daniel Koppers

Daniel Koppers

Head Of Research And Development, Phlexglobal
Daniel Koppers, Head of Research and Development at Phlexglobal, is a passionate technologist with a natural attraction towards anything that is "impossible". Keen to simplify technology and automation and currently working on introducing AI and Machine Learning to the pharmaceutical... Read More →
avatar for Marisa Minetti

Marisa Minetti

Head of Late Phase Clinical Trial Administration, Chiesi
Marisa is currently Head of Late Phase Clinical Trial Administration in Chiesi Farmaceutici SpA and is based in Parma (Italy). She heads a team that is also responsible for the oversighting of clinical documentation filing in eTMF for global studies ranging from Phase IIB to Phase... Read More →


Wednesday November 4, 2020 10:20am - 10:50am EST

10:50am EST

Networking Break
Wednesday November 4, 2020 10:50am - 11:20am EST

11:20am EST

TMF in the Virtual Inspection Reality
  • Implications of accessing your TMF in a virtual inspection/audit landscape
  • Summary of a sponsor’s experience (and lessons learned) in recent virtual GCP inspections (Health Canada, MHRA)

Speakers
avatar for Liz Farrell

Liz Farrell

Associate Director, Global Safety and Regulatory Sciences Records Management, Trial Master File, Biogen
Liz is an Associate Director within Records Management-TMF at Biogen and currently oversees TMF process and quality for phase I-IV trials to ensure ongoing compliance across the organization. During Liz’s 7+ years at Biogen, she has been involved in numerous regulatory inspections... Read More →


Wednesday November 4, 2020 11:20am - 11:50am EST

11:55am EST

Simplifying and Ensuring Compliance with a Unified, Automated eTMF
  • Focus on overcoming the challenges associated with maintaining visibility to inspection-readiness arising from the increased complexities of today's clinical trials.

Speakers
avatar for Tim Galvin

Tim Galvin

Director of Product Management, Medidata
Tim is Director of Product for the RCM platform which includes Medidata's eTMF, Site Cloud: End of Study, Archive, and Quality: SOP Management. He joined Medidata with over 16 years of experience in clinical research. Tim spent most of his clinical career working within Trial Management... Read More →


Wednesday November 4, 2020 11:55am - 12:25pm EST

12:30pm EST

Proper Oversight During TMF Migration and How to Switch Between eTMFs
  • Gain insights on real-world experiences in migrating eTMFs and what procedural and technical standards were utilized
  • Understand important considerations to successfully migrate eTMFs including good oversight of the process

Moderators
avatar for Allison Varjavandi

Allison Varjavandi

Director, Global Central Medical Files, Astellas
Allison has worked in clinical research in various roles over the past 22 years with her most recent experience leading TMF strategies. As the eTMF Business Process Owner for her company, she is accountable for establishing and driving a comprehensive global strategy resulting in... Read More →

Speakers
avatar for Ronla Prince

Ronla Prince

TMF Services Lead, Global Clinical Solutions, Development Operations, AstraZeneca
Ronla has worked in the Clinical Research industry for 20 years.  She has worked in various positions at the site level in Oncology research at Memorial Sloan-Kettering Cancer Center and Washington Cancer Institute/MedStar Washington Hospital Center; and in Cardiovascular research... Read More →
avatar for Noeleen Valenzuela

Noeleen Valenzuela

Associate Director, TMF and Document Management, Alnylam UK Limited
I have 18+ years in pharma development ranging with roles in big pharma, CROs and vendors. I spent 4+ years of that time in pure TMF roles with a vendor working on TMF inspection readiness for 3 years and TMF quality for 1+ year. I am currently leading the TMF efforts at Alnylam... Read More →
avatar for Alison Hussain

Alison Hussain

Senior Project Manager, TransPerfect
I have over 20 years’ experience working within the healthcare industry having worked for both sponsors and CROs in a variety of roles from CTA, R&D Advisor, Quality Manager, Operations Manager and currently Senior Project Manager.My current role is all about delivering complex... Read More →


Wednesday November 4, 2020 12:30pm - 1:15pm EST

1:15pm EST

Chairperson's Closing Remarks
Speakers
avatar for Jamie Marie Toth, CPM, MS

Jamie Marie Toth, CPM, MS

Senior Director, Clinical Systems & Records, Global Clinical Operations & Planning, Daiichi Sankyo, Inc
Jamie Marie Toth, Senior Director Clinical Systems & Records at Daiichi Sankyo Inc, USA.Ms. Toth has been with Daiichi Sankyo, Inc. since 2016, and is the business owner for the eTMF system, the SNL IB solution, and the CTMS system. Her department oversees TMF Operations, clinical... Read More →
avatar for Karen Roy

Karen Roy

Chief Strategy Officer, Phlexglobal
Karen Roy has been responsible for the development of the TMF business at Phlexglobal since 2007, with a focus on creating solutions for our Clients’ TMF challenges. She started in Business Development, moving to Client Solutions, and now her focus is on strategy. In her role as... Read More →
avatar for Marie-Christine Poisson-Carvajal

Marie-Christine Poisson-Carvajal

Head of TMF and Registry, Pfizer
Marie-Christine is the Head of TMF & Registry Operations and the TMF Business Process Owner at Pfizer. She is responsible for developing and executing strategy for continuous TMF quality and efficiency improvements, driving execution and performance data for all TMF roles and activities... Read More →
avatar for Wendy Beeby

Wendy Beeby

Director, Clinical Document Management and Trial Support, Takeda Pharmaceuticals
Wendy Beeby is Director of Clinical Document Management and Inspection Readiness at Takeda, responsible for the strategic direction of clinical document management and working in collaboration with functional leads to implement effective inspection readiness and support plans.  With... Read More →


Wednesday November 4, 2020 1:15pm - 1:25pm EST

1:30pm EST

Zoom Rountable: 2021 and Beyond: Innovations in eTMF in the Current Climate
Join this roundtable discussion to share thought leadership on which aspects of TMF innovation have taken priority as a result of the current climate.

Speakers
avatar for Tim Galvin

Tim Galvin

Director of Product Management, Medidata
Tim is Director of Product for the RCM platform which includes Medidata's eTMF, Site Cloud: End of Study, Archive, and Quality: SOP Management. He joined Medidata with over 16 years of experience in clinical research. Tim spent most of his clinical career working within Trial Management... Read More →


Wednesday November 4, 2020 1:30pm - 2:30pm EST

1:30pm EST

Zoom Rountable: How Organizations are Collaborating More Effectively to Improve Speed, Quality, Efficiency
Clinical trials continue to evolve, and the COVID pandemic has highlighted the complexity and need for study sites, sponsors, and CROs to be better connected across systems, processes, and people. The industry is rapidly modernizing and adopting new approaches to achieve that goal and accelerate research. Join this roundtable to explore best practices for improving how sponsors, CROs, and sites work together throughout study execution.

Speakers
avatar for Chris McSpiritt

Chris McSpiritt

Senior Director, Vault Clinical, Veeva Systems
Chris is part of Veeva's R&D Strategy group with a focus on the Vault Clinical Operations Suite. He works with clients and prospects to understand their pain points and to align software solutions with their desired future state. Prior to his tenure at Veeva, Chris worked for 8 years... Read More →


Wednesday November 4, 2020 1:30pm - 2:30pm EST
 
Thursday, November 5
 

9:00am EST

Chairperson’s Opening Remarks
Speakers
avatar for Jamie Marie Toth, CPM, MS

Jamie Marie Toth, CPM, MS

Senior Director, Clinical Systems & Records, Global Clinical Operations & Planning, Daiichi Sankyo, Inc
Jamie Marie Toth, Senior Director Clinical Systems & Records at Daiichi Sankyo Inc, USA.Ms. Toth has been with Daiichi Sankyo, Inc. since 2016, and is the business owner for the eTMF system, the SNL IB solution, and the CTMS system. Her department oversees TMF Operations, clinical... Read More →
avatar for Karen Roy

Karen Roy

Chief Strategy Officer, Phlexglobal
Karen Roy has been responsible for the development of the TMF business at Phlexglobal since 2007, with a focus on creating solutions for our Clients’ TMF challenges. She started in Business Development, moving to Client Solutions, and now her focus is on strategy. In her role as... Read More →
avatar for Marie-Christine Poisson-Carvajal

Marie-Christine Poisson-Carvajal

Head of TMF and Registry, Pfizer
Marie-Christine is the Head of TMF & Registry Operations and the TMF Business Process Owner at Pfizer. She is responsible for developing and executing strategy for continuous TMF quality and efficiency improvements, driving execution and performance data for all TMF roles and activities... Read More →
avatar for Wendy Beeby

Wendy Beeby

Director, Clinical Document Management and Trial Support, Takeda Pharmaceuticals
Wendy Beeby is Director of Clinical Document Management and Inspection Readiness at Takeda, responsible for the strategic direction of clinical document management and working in collaboration with functional leads to implement effective inspection readiness and support plans.  With... Read More →


Thursday November 5, 2020 9:00am - 9:10am EST

9:10am EST

Challenges in Assessing TMF Completeness without an eTMF system
Speakers
avatar for Ashlyn Deshaies

Ashlyn Deshaies

Clinical and TMF Operations Manager, TG Therapeutics, Inc.
Ashlyn Deshaies serves as the Associate Director of Clinical and TMF Operations at TG Therapeutics overseeing the planning and execution of TMF processes, quality reviews, and TMF scoped deliverables. Ashlyn has driven implementation TMF maintenance guidelines based on the "three... Read More →


Thursday November 5, 2020 9:10am - 9:40am EST

9:45am EST

Collaborating Effectively to Transform Clinical Trials
  • Review the latest industry direction and technology trends in connecting sponsors, CROs, and sites to accelerate clinical research
  • Explore innovative approaches to enhance collaboration by enabling paperless information exchange
  • Discuss opportunities to automate the flow of study information across clinical trial systems, processes, and partners

Speakers
avatar for Chris McSpiritt

Chris McSpiritt

Senior Director, Vault Clinical, Veeva Systems
Chris is part of Veeva's R&D Strategy group with a focus on the Vault Clinical Operations Suite. He works with clients and prospects to understand their pain points and to align software solutions with their desired future state. Prior to his tenure at Veeva, Chris worked for 8 years... Read More →


Thursday November 5, 2020 9:45am - 10:15am EST

10:20am EST

Discuss CRO, Sponsor, and Site Collaboration and Best Practices
Moderators
avatar for Vittoria Sparacio

Vittoria Sparacio

Global Head, Clinical Document Governance & Management, Novartis
Vittoria has recently joined Novartis as Global Head, Clinical Document Governance & Management. She was previously with GSK Pharmaceutical R&D where she headed up the Clinical Documentation group and established document management processes, systems and standards for quality and... Read More →

Speakers
avatar for Stephanie Mayew

Stephanie Mayew

Manager of Clinical Operations, PRA Health Sciences
Stephanie Mayew has 17 years of clinical research experience and is currently the Business Lead for implementation of a new eTMF solution. She is also responsible for management of TMF Global Services in accordance with PRA policies, procedures, SOPs, ICH-GCP guidelines, local regulatory... Read More →
avatar for Joanne Malia

Joanne Malia

Director, Clinical Documentation Management, Regeneron Pharmaceuticals, Inc.
Joanne Malia is Director, Clinical Documentation Management at Regeneron Pharmaceuticals and responsible for the TMF group and Clinical Archives and is the Business Process Owner for the eTMF.  Throughout her 25+ year career in life sciences she has worked for diagnostic, biotech... Read More →
avatar for Leanne Rice

Leanne Rice

Clinical Documentation Manager, GSK
Leanne graduated from the London School of Hygiene & Tropical Medicine, joining GSK in 1992 as a Statistician. Leanne worked on clinical trials, being involved with all aspects from protocol writing to reporting and publication. The role expanded to cover other areas such as Investigator... Read More →
avatar for Pawel Rucki

Pawel Rucki

Senior Manager, TMF Operations Clinical Operations Excellence, GW Pharmaceuticals
Pawel joined GW Pharmaceuticals in September 2015 in the newly created role of Clinical Process Improvement Officer and was responsible for developing and executing restructure of the TMF. Shortly after he became a Manager in Clinical Process Improvement and in 2018 Pawel spear-headed... Read More →


Thursday November 5, 2020 10:20am - 11:05am EST

11:05am EST

Networking Break
Thursday November 5, 2020 11:05am - 11:35am EST

11:35am EST

Deep Dive into CRO Oversight through TMF
  • Discuss Oversight in Clinical Trial
  • Review TMF as an Oversight Tool
  • Understand the importance of the TMF Plan
  • Hone in on oversight for Inspection and Audit

Speakers
avatar for Donatella Ballerini

Donatella Ballerini

Document & Training Manager, Global Rare Diseases, CHIESI FARMACEUTICI S.p.A
I started my career in Chiesi almost 11 years ago after some work experiences in indifferent fields and a Master Degree in Touristic Science.I was involved in the very first line with the big project of a New R&D Center in Parma and I started to work in the Engineering and Validation... Read More →


Thursday November 5, 2020 11:35am - 12:05pm EST

12:10pm EST

The Road to TMF Quality: Improve Site Regulatory Oversight
  • Review the obstacles today including remote work
  • Understand the pains associated with site regulatory work
  • Define a clear solution to provide better sponsor/CRO oversight and improve work for the sites

Speakers
avatar for Dylan Loch

Dylan Loch

Director, Industry Business Development, Complion
With 8 years of experience in business development for technology companies, Dylan understands how to achieve organizational outcomes through innovation. Dylan served as the director of site business development prior to overseeing industry business development, therefore brings together... Read More →


Thursday November 5, 2020 12:10pm - 12:40pm EST

12:45pm EST

Managing the Exchange of Documents Between Sponsor eTMF and (e)ISF
  • Review current approaches of document exchange (questions can point to the hurdles for automated exchange)
  • Discuss the use of technology to streamline document exchange and reconciliation (questions pointing to the requirements to leverage technology)
  • Explore a vision for the future

Moderators
avatar for Dr. Martina Duevel

Dr. Martina Duevel

Systems Excellence Project Leader,, Bayer AG Research & Development, Pharmaceuticals System Integration
Martina Duevel has been working in the pharmaceutical industry for 20+ years in different roles in Clinical Quality Assurance and Clinical Project Management. In 2015 she lead the implementation of Bayer's for eTMF implementation and subsequently headed the maturation program. Her... Read More →

Speakers
avatar for Colleen Butler

Colleen Butler

Global Head of TMF, Senior Director, TMF Operations, Syneos Health Global Headquarters
Leads a TMF Business Unit of 350+ TMF experts with 16 years TMF experience.
avatar for M. Christine Morris

M. Christine Morris

Executive Director, Life Sciences Solutions, TransPerfect
Christine Morris is an Executive Director in the Life Sciences Solutions division of TransPerfect, specializing in collaboration and content management solutions for Sponsors, CROs, and Sites. She has 25+ years’ technology, business process, consulting, product, leadership, management... Read More →
avatar for Etienne Hinton

Etienne Hinton

Clinical Trial Coordinator I, Duke Clinical Research Institute
An experienced professional with over 13 years of knowledge and experience in the CRO industry. During that spending time at both CROs and currently at an ARO. I contain a vast depth of experience and knowledge in drug safety, clinical affairs and site relationship management across... Read More →


Thursday November 5, 2020 12:45pm - 1:30pm EST

1:30pm EST

Chairperson's Closing Remarks
Speakers
avatar for Jamie Marie Toth, CPM, MS

Jamie Marie Toth, CPM, MS

Senior Director, Clinical Systems & Records, Global Clinical Operations & Planning, Daiichi Sankyo, Inc
Jamie Marie Toth, Senior Director Clinical Systems & Records at Daiichi Sankyo Inc, USA.Ms. Toth has been with Daiichi Sankyo, Inc. since 2016, and is the business owner for the eTMF system, the SNL IB solution, and the CTMS system. Her department oversees TMF Operations, clinical... Read More →
avatar for Karen Roy

Karen Roy

Chief Strategy Officer, Phlexglobal
Karen Roy has been responsible for the development of the TMF business at Phlexglobal since 2007, with a focus on creating solutions for our Clients’ TMF challenges. She started in Business Development, moving to Client Solutions, and now her focus is on strategy. In her role as... Read More →
avatar for Marie-Christine Poisson-Carvajal

Marie-Christine Poisson-Carvajal

Head of TMF and Registry, Pfizer
Marie-Christine is the Head of TMF & Registry Operations and the TMF Business Process Owner at Pfizer. She is responsible for developing and executing strategy for continuous TMF quality and efficiency improvements, driving execution and performance data for all TMF roles and activities... Read More →
avatar for Wendy Beeby

Wendy Beeby

Director, Clinical Document Management and Trial Support, Takeda Pharmaceuticals
Wendy Beeby is Director of Clinical Document Management and Inspection Readiness at Takeda, responsible for the strategic direction of clinical document management and working in collaboration with functional leads to implement effective inspection readiness and support plans.  With... Read More →


Thursday November 5, 2020 1:30pm - 1:40pm EST

1:45pm EST

Zoom Rountable: How to Avoid Remote Monitoring Failure: A Site First Strategy for Remote Access
Discuss how sponsors and CROs like Pfizer, Natera, Altum, CIBMTR are working with leading sites like Vanderbilt-Ingram Cancer Center, Mt. Sinai, City of Hope, AtriumHealth, Northwell, and others to turn on remote site access.

Speakers
avatar for Blake Adams

Blake Adams

VP Marketing, Florence
Blake focuses on identifying bottlenecks in clinical operations processes and solving them with technology that benefits both the sponsor and the site. Blake has been with Florence as Vice President of Marketing since the early days of the company. In this time, Florence has grown... Read More →


Thursday November 5, 2020 1:45pm - 2:45pm EST

1:45pm EST

Zoom Rountable: When TMF Issues Shouldn't be TMF Issues
  • Discuss the struggles of monitoring in COVID times and the impact of on the TMF
  • Share best practices for ensuring quality in site regulatory work and maintaining an inspection-ready TMF, even during a pandemic
  • Understand what should and should NOT be issues related to the TMF

Speakers
avatar for Dylan Loch

Dylan Loch

Director, Industry Business Development, Complion
With 8 years of experience in business development for technology companies, Dylan understands how to achieve organizational outcomes through innovation. Dylan served as the director of site business development prior to overseeing industry business development, therefore brings together... Read More →


Thursday November 5, 2020 1:45pm - 2:45pm EST
 
Friday, November 6
 

9:00am EST

Chairperson’s Opening Remarks
Speakers
avatar for Jamie Marie Toth, CPM, MS

Jamie Marie Toth, CPM, MS

Senior Director, Clinical Systems & Records, Global Clinical Operations & Planning, Daiichi Sankyo, Inc
Jamie Marie Toth, Senior Director Clinical Systems & Records at Daiichi Sankyo Inc, USA.Ms. Toth has been with Daiichi Sankyo, Inc. since 2016, and is the business owner for the eTMF system, the SNL IB solution, and the CTMS system. Her department oversees TMF Operations, clinical... Read More →
avatar for Karen Roy

Karen Roy

Chief Strategy Officer, Phlexglobal
Karen Roy has been responsible for the development of the TMF business at Phlexglobal since 2007, with a focus on creating solutions for our Clients’ TMF challenges. She started in Business Development, moving to Client Solutions, and now her focus is on strategy. In her role as... Read More →
avatar for Marie-Christine Poisson-Carvajal

Marie-Christine Poisson-Carvajal

Head of TMF and Registry, Pfizer
Marie-Christine is the Head of TMF & Registry Operations and the TMF Business Process Owner at Pfizer. She is responsible for developing and executing strategy for continuous TMF quality and efficiency improvements, driving execution and performance data for all TMF roles and activities... Read More →
avatar for Wendy Beeby

Wendy Beeby

Director, Clinical Document Management and Trial Support, Takeda Pharmaceuticals
Wendy Beeby is Director of Clinical Document Management and Inspection Readiness at Takeda, responsible for the strategic direction of clinical document management and working in collaboration with functional leads to implement effective inspection readiness and support plans.  With... Read More →


Friday November 6, 2020 9:00am - 9:10am EST

9:10am EST

Enabling Globally Compliant Remote Site Access for Monitoring and Source Verification
  • Learn how sponsors like Pfizer, Altum, SeaSpine, Natera, CIBMTR, and others are turning on global remote site access
  • See why a site-first solution helps to accelerate activation and implementation
  • Learn how sponsors and CROs are connecting site eISFs directly to their eTMF for document exchange

Speakers
avatar for Blake Adams

Blake Adams

VP Marketing, Florence
Blake focuses on identifying bottlenecks in clinical operations processes and solving them with technology that benefits both the sponsor and the site. Blake has been with Florence as Vice President of Marketing since the early days of the company. In this time, Florence has grown... Read More →
avatar for Ty Quinn

Ty Quinn

VP/GM Sponsors + CROs, Florence
Ty Quinn is Vice President and General Manager for Contract Research Organizations (CROs) and Sponsors at Florence, the leading eISF + Remote Site Access platform in clinical trials with more than 8,000 study sites in 27 countries connected to the platform. Ty works with industry... Read More →


Friday November 6, 2020 9:10am - 9:40am EST

9:45am EST

Get Ready for ICH E6 R3!
  • Learn why ICH E6 is being updated
  • Understand the impact the new version is expected to have on industry
  • How can we prepare for the new version?

Speakers
avatar for Betsy Fallen

Betsy Fallen

Principal, BAFallen Consulting LLC
Betsy has worked in healthcare settings from nursing to pharma and as an independent contributor. An expert in regulatory, clinical and PV, Betsy supports industry by sharing her expertise and experiences. Betsy is an advocate for leveraging innovative, digital practices while considering... Read More →


Friday November 6, 2020 9:45am - 10:15am EST

10:20am EST

Discussion on Archiving Timelines
  •  How to manage an archived state with changing technology

Moderators
avatar for Jamie Marie Toth, CPM, MS

Jamie Marie Toth, CPM, MS

Senior Director, Clinical Systems & Records, Global Clinical Operations & Planning, Daiichi Sankyo, Inc
Jamie Marie Toth, Senior Director Clinical Systems & Records at Daiichi Sankyo Inc, USA.Ms. Toth has been with Daiichi Sankyo, Inc. since 2016, and is the business owner for the eTMF system, the SNL IB solution, and the CTMS system. Her department oversees TMF Operations, clinical... Read More →

Speakers
avatar for Angel Ramos, Jr., CRM, IGP, MLIS

Angel Ramos, Jr., CRM, IGP, MLIS

Manager, Clinical Records Management, Clinical Systems & Records, Global Clinical Operations & Planning, Daiichi Sankyo, Inc.
I have 12 years of experience in pharmaceutical records management with Daiichi Sankyo, Inc., Mylan and Sanofi. I created a global records management and physical archives program at Mylan. Before starting as eTMF Archivist at Daiichi Sankyo, Inc., I worked on a 2-year records inventory... Read More →
avatar for Hobson Lopes

Hobson Lopes

Manager, Clinical Archive Management, Regeneron Pharmaceuticals, Inc.
Hobson Lopes has been in the industry more than 8 years, all in the records management space. He is currently at Regeneron where he serves as Manager of the Clinical Archives. He is also the named GCP Archivist, serves as TMF Inspection Lead, and is also a member of several industry... Read More →
avatar for Russell Joyce

Russell Joyce

Director & Principal Consultant, Heath Barrowcliff Consulting Ltd.
Independent Freelance Records Management and Information Governance Consultant with 20+ years’ experience in the life sciences and legal sectors | Active Member of the TMF Reference Model Steering Committee and Project Lead on Real Word Evidence Study Master File taskforce | Director... Read More →
avatar for Ralph Feaga

Ralph Feaga

TMF Operations Lead/Archivist, AstraZeneca
Over 20 years ago, Ralph began his TMF career with a senior records management role at PPD, soon rising to a management level overseeing records processing and archiving in two offices. Transitioning to a small biotech company six years later, he stepped out of TMF and became the... Read More →


Friday November 6, 2020 10:20am - 11:05am EST

11:05am EST

Networking Break
Friday November 6, 2020 11:05am - 11:35am EST

11:35am EST

TMF: The Sponsor’s Achilles Heel during a Regulatory Inspection
  • Focus and thinking behind an inspection; how MHRA literally wrote the book
  • Understand what MHRA and EMEA inspection metrics reveal about GCP compliance at sponsor, CRO, and investigator sites
  • Discover where the buck stops and some simple advice to ensure inspection readiness

Speakers
avatar for Dr. Andrew Bentley

Dr. Andrew Bentley

Quality Assurance Manager, MiNA Therapeutics
Andrew Bentley started his career in academic research at the University of Sussex and Oxford.  He has over three decades of experience in GxP environments, starting in GMP then moving on to work in GCP at three major global CROs.  He has implemented a number of quality management... Read More →


Friday November 6, 2020 11:35am - 12:05pm EST

12:10pm EST

The Role of eTMF in Unified eClinical Technology
  • eTMF’s touchpoints with other technology
  • The dangers of inconsistent information
  • Mining eTMF information to support clinical risk management
  • Best practice for technology and process

Speakers
avatar for Kathie Clark

Kathie Clark

Product Director, CTMS and eTMF, Ennov
Kathie is Director, eTMF and CTMS for Ennov. She provides thought leadership for the industry and is the author of many white papers, journal articles and blog posts on eTMF, eClinical and regulatory topics. She is a member of the TMF Reference Model steering committee and has chaired... Read More →


Friday November 6, 2020 12:10pm - 12:40pm EST

12:45pm EST

Proper oversight of TMF for validations, system upgrades, audit trail reviews, and systems support
  • Review your Data Integrity Checklist: Where to start and how to finish
  • Discuss guides on Data Integrity and review key Principles of Data Integrity
  • Dive into Audit Trial Reviews: quality system approach to implementing oversight and review, validation, system upgrade, and audit trail reviews
  • System security and protection: cybersecurity trends, detection & response, and security checkpoints

Moderators
avatar for Barbara A. Novak, BS MT(ASCP)

Barbara A. Novak, BS MT(ASCP)

Systems and Process Management Lead Clinical Operations - NA/EU, Kyowa Kirin Pharmaceutical Development, Inc.

Speakers
avatar for Jamie Marie Toth, CPM, MS

Jamie Marie Toth, CPM, MS

Senior Director, Clinical Systems & Records, Global Clinical Operations & Planning, Daiichi Sankyo, Inc
Jamie Marie Toth, Senior Director Clinical Systems & Records at Daiichi Sankyo Inc, USA.Ms. Toth has been with Daiichi Sankyo, Inc. since 2016, and is the business owner for the eTMF system, the SNL IB solution, and the CTMS system. Her department oversees TMF Operations, clinical... Read More →
avatar for Karen Roy

Karen Roy

Chief Strategy Officer, Phlexglobal
Karen Roy has been responsible for the development of the TMF business at Phlexglobal since 2007, with a focus on creating solutions for our Clients’ TMF challenges. She started in Business Development, moving to Client Solutions, and now her focus is on strategy. In her role as... Read More →
avatar for Rebecca Halbur, A.L.M.

Rebecca Halbur, A.L.M.

Assoc. Director, Trial Master File (TMF) Systems, Biogen
Rebecca Halbur is the eTMF business system owner at Biogen. Her 11 years of experience in TMF spans document processing, people management, and system oversight in both CRO and biotech where she helped sponsors setup and navigate the TMF environment, assisted with implementing & migrating... Read More →
avatar for Supriya Shoroff, MS

Supriya Shoroff, MS

Associate Director - TMF, Clinical Operations, AMAG Pharmaceuticals, Inc.
Supriya Shoroff is an Associate Director, heading the TMF operations at AMAG Pharmaceuticals in Boston, MA. She has over 12+ years of experience in the R&D, pharmaceutical Industry and has supported/led multiple agency Inspections. She has Implemented several eTMF systems, designed... Read More →


Friday November 6, 2020 12:45pm - 1:30pm EST

1:30pm EST

Chairperson's Closing Remarks
Speakers
avatar for Jamie Marie Toth, CPM, MS

Jamie Marie Toth, CPM, MS

Senior Director, Clinical Systems & Records, Global Clinical Operations & Planning, Daiichi Sankyo, Inc
Jamie Marie Toth, Senior Director Clinical Systems & Records at Daiichi Sankyo Inc, USA.Ms. Toth has been with Daiichi Sankyo, Inc. since 2016, and is the business owner for the eTMF system, the SNL IB solution, and the CTMS system. Her department oversees TMF Operations, clinical... Read More →
avatar for Karen Roy

Karen Roy

Chief Strategy Officer, Phlexglobal
Karen Roy has been responsible for the development of the TMF business at Phlexglobal since 2007, with a focus on creating solutions for our Clients’ TMF challenges. She started in Business Development, moving to Client Solutions, and now her focus is on strategy. In her role as... Read More →
avatar for Marie-Christine Poisson-Carvajal

Marie-Christine Poisson-Carvajal

Head of TMF and Registry, Pfizer
Marie-Christine is the Head of TMF & Registry Operations and the TMF Business Process Owner at Pfizer. She is responsible for developing and executing strategy for continuous TMF quality and efficiency improvements, driving execution and performance data for all TMF roles and activities... Read More →
avatar for Wendy Beeby

Wendy Beeby

Director, Clinical Document Management and Trial Support, Takeda Pharmaceuticals
Wendy Beeby is Director of Clinical Document Management and Inspection Readiness at Takeda, responsible for the strategic direction of clinical document management and working in collaboration with functional leads to implement effective inspection readiness and support plans.  With... Read More →


Friday November 6, 2020 1:30pm - 2:00pm EST