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Tuesday, May 18
 

8:00am EDT

TMF Management Plan Template Institute
The TMF Management Plan is the first artifact of the TMF Reference Model created by the DIA Working Group. You may ask…why is that? Because it is important! It sets the expectations for the Trial Master File for each clinical study. While its content will vary from company to company, in this workshop we will review the constructs of the TMF Plan Template created by a subgroup of the TMF Reference Model, and use real examples of how to create your plan for your company. 
This workshop will review the expectations of regulatory authorities as well as best practices from the presenters and all of you! 
Topics that will be addressed during this workshop are: 
  • View the TMF Management Plan through the eyes of health authorities.
  • Clarify how critical the TMF Management Plan is to overall TMF Management processes.
  • Walk-through of key sections of the TMF Plan Template created by the TMF RM subgroup.
  • Get and generate ideas from others on the TMF Plan.
  • How to create your own TMF Plan Template.



Speakers
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 →
avatar for Jamie Marie Toth, CPM, MS

Jamie Marie Toth, CPM, MS

Senior Director, Clinical Systems & Records, Daiichi Sankyo, Inc.


Tuesday May 18, 2021 8:00am - 11:00am EDT
Zoom

12:00pm EDT

Inspection Planning Institute: The Do's and Dont's of Preparing for a GCP Inspection (On-Site and Remote)
“By failing to prepare, you are preparing to fail.” – Benjamin Franklin

The industry has observed regulatory authorities evolve their inspection expectations in step with the increasing complexity of clinical trials and available eClinical technology, among other variables. With the ongoing pandemic, further changes have emerged as remote inspections have become necessary. Are these remote inspections here to stay?
This session will look at how to prepare for both on-site and remote inspections so that teams can prepare for whatever the future may hold. Attendees will learn preparation best practices, including:
  • Inspection plans
  • Settings and location
  • Systems access
  • Document requests
  • Inspection agendas
  • Documents and eTMF best practices (What are the inspectors looking for)

Speakers
avatar for Gillian Gittens

Gillian Gittens

Director, e-Clinical Strategy & Solutions, TransPerfect Life Sciences
Gillian is Director of eClinical Strategy and Solutions for Trial Interactive, TransPerfect’s eClinical platform. A career Trial Master File and eTMF subject matter expert with over 20 years of experience, she has a wide range of experience across operations, implementation... Read More →
avatar for Laurel-Ann Schrader

Laurel-Ann Schrader

Director, Client Solutions, TransPerfect Life Sciences
As Director, Client Solutions at TransPerfect Life Sciences, Laurel-Ann Schrader is a resident TMF subject matter expert.Her expertise includes TMF inspection readiness, preparation, and support, best practices for clinical document processes, procedures and clinical operations, eTMF... Read More →


Tuesday May 18, 2021 12:00pm - 3:00pm EDT
Zoom
 
Wednesday, May 19
 

9:00am EDT

Chairperson’s Opening Remarks
Speakers
avatar for Wendy Beeby

Wendy Beeby

Director, Clinical Document Management and Trial Support, Takeda Pharmacueuticals
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 →
avatar for Grace Crawford

Grace Crawford

Global Head, Clinical Quality & Compliance, AstraZeneca R&D
Grace Crawford is an accomplished quality and compliance leader with over 27 years of experience working with international clinical trials, quality systems, regulatory compliance, and computer systems validation in the pharmaceutical, medical device, and biotech industries across GxP’s (GCP/GLP/cGMP). Her... Read More →
avatar for Jamie Marie Toth, CPM, MS

Jamie Marie Toth, CPM, MS

Senior Director, Clinical Systems & Records, Daiichi Sankyo, Inc.
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... Read More →


Wednesday May 19, 2021 9:00am - 9:15am EDT

9:15am EDT

Streamlining the TMF Process to Optimize TMF Quality
  • Join an interactive session about streamlining the TMF process through ongoing delivery of operational efficiencies to enhance TMF quality and compliance.
  • Hear real-world stories and lessons learned to help you tailor for your company.

Speakers
avatar for Mary Emanoil

Mary Emanoil

Head TMF and Registry Operations, Pfizer
Mary has been with Pfizer for over 25 years and has held positions in Information Management, Pharmaceutical Sciences and Business Technologies. She is currently Head of TMF and Registry Operations where she leads a team of experts in the management of these critical clinical processes... Read More →


Wednesday May 19, 2021 9:15am - 9:50am EDT

9:55am EDT

Deep Dive into Certified Copies
If you have questions about TMF certified copies, you are not alone. In this session, TransPerfect Director of eClinical Strategy & Solutions Gillian Gittens will answer the most important—and most frequent—questions clinical researchers ask about certified copies for the TMF.
In this session, you’ll learn:
  • What defines a certified copy, and why you need one
  • How to verify an exact copy
  • How to create a certified copy

Speakers
avatar for Gillian Gittens

Gillian Gittens

Director, e-Clinical Strategy & Solutions, TransPerfect Life Sciences
Gillian is Director of eClinical Strategy and Solutions for Trial Interactive, TransPerfect’s eClinical platform. A career Trial Master File and eTMF subject matter expert with over 20 years of experience, she has a wide range of experience across operations, implementation... Read More →


Wednesday May 19, 2021 9:55am - 10:30am EDT

10:35am EDT

Review Mergers, Migrations and Transfers Best Practices
Moderators
avatar for Rebecca Halbur, A.L.M.

Rebecca Halbur, A.L.M.

Assoc. Director, Trial Master File (TMF) Systems, Biogen
Rebecca Halbur is the business system owner of the TMF at Biogen. Her 11+ years of TMF experience spans various TMF models including document processing, people management, and system oversight in CRO and biotech.   She has also setup and navigated the complex global TMF environment... Read More →

Speakers
avatar for Chaitanya Joshi MS MBA

Chaitanya Joshi MS MBA

Senior Manager, eTMF Operations, bluebird bio
CJ is a resident TMF expert at bluebird bio with 13 years of biopharmaceutical industry experience in TMF management. He gained his expertise in TMF operations and systems having worked on different eTMF tools over the years with multiple companies. During the last 3 years at bluebird... Read More →
avatar for Keith Win, MS

Keith Win, MS

Manager, Clinical Systems (eTMF), Daiichi Sankyo, Inc.
Keith is a Manager Clinical Systems at Daiichi Sankyo, Inc.  He has been working for DS for 4 years.  Keith is responsible for executing change control projects, data migration, exports, and storage, as well as metrics generation.  Prior to Daiichi Sankyo, Keith worked for Janssen... Read More →
avatar for Pawel Rucki

Pawel Rucki

Senior Clinical Lead, BASE Life Science
Pawel Rucki, Senior Clinical Lead at BASE life science. Pawel has worked in Clinical Operations for over 10 years with Pharmaceutical sponsors and CROs, responsible for inspections readiness, records management, CRO oversight and archiving.At BASE life science Pawel is responsible... Read More →


Wednesday May 19, 2021 10:35am - 11:25am EDT

11:25am EDT

“Meet the Speakers” Party
Missing out on the networking aspect of live events? Your question didn’t get answered during the Q&A portion of a session? Grab a snack and mingle with today’s speakers and attendees in these zoom breakout rooms

Wednesday May 19, 2021 11:25am - 11:55am EDT
Zoom

11:55am EDT

Afternoon Chairperson’s Introduction
Speakers
avatar for Wendy Beeby

Wendy Beeby

Director, Clinical Document Management and Trial Support, Takeda Pharmacueuticals
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 →
avatar for Grace Crawford

Grace Crawford

Global Head, Clinical Quality & Compliance, AstraZeneca R&D
Grace Crawford is an accomplished quality and compliance leader with over 27 years of experience working with international clinical trials, quality systems, regulatory compliance, and computer systems validation in the pharmaceutical, medical device, and biotech industries across GxP’s (GCP/GLP/cGMP). Her... Read More →


Wednesday May 19, 2021 11:55am - 12:00pm EDT

12:00pm EDT

Utilizing Technology to Minimize Inspection Risk During M&A
Speakers
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... Read More →
avatar for Sarah Tucker

Sarah Tucker

Senior VP, Customer Success, Phlexglobal
Sarah has 20 years’ experience working with Trial Master Files having started her career at Pfizer and moved from the Sponsor side of TMFs to Phlexglobal in 2007 to grow out TMF services. Sarah now resides in Pennsylvania, USA and is the SVP Customer Management for Phlexglobal ensuring... Read More →


Wednesday May 19, 2021 12:00pm - 12:35pm EDT

12:35pm EDT

How to Work with Partners: Sponsors, CROs, Vendors and More!
  • Who is the main Study Sponsor? Sponsor Partners, CRO Partners, Vendors, Third Party Vendors?
  • Who is responsible for the TMF/eTMF? What’s in your contracts, what’s noted in your TORO?
  • Who is responsible and accountable? What does Sponsor Oversight mean?
    • Sponsor Partner, CRO, Vendor, Third-party, sites, and more

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

Barbara A. Novak, BS MT(ASCP)

Associate Director, Clinical Operations Systems & Process, Kyowa Kirin, Inc
Barbara Novak is the Associate Director of Clinical Operations Systems and Process at Kyowa Kirin USA (KKUSA). She has worked in clinical drug development for over 30-years, has been employed at KKUSA since 2009 (12+ years) with focused expertise in immunology, oncology, CNS-Parkinson’s... Read More →

Speakers
avatar for Darshan Patel

Darshan Patel

Customer Success Leader, eTMF, IQVIA Technologies
Darshan Patel is a Customer Success leader for IQVIA eTMF systems. He is responsible for client relationships, training needs, system upgrades and migrations. Darshan has significant clinical experience in both CRO and sponsor settings, in several GXP environments. He has focused... 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 Aryn Knight

Aryn Knight

Administrative Director, Center for Clinical Research, Texas Heart Institute
Aryn Knight, CCRP, is Administrative Director at Texas Heart Institute, Center for Clinical Research in Houston, TX. She is a Certified Clinical Research Professional (CCRP) with more than 20 years of direct experience in clinical research in academia and hospital environments. Since... Read More →
avatar for David Ives

David Ives

Senior Director, Head of Clinical Operations Systems and Information Management, Alexion Pharmaceuticals, Inc.
David Ives is the Senior Director, Clinical Operations Systems and Information Management at Alexion Pharmaceuticals Inc. He leads a team of technical and process domain experts to ensure consistency of process, system configuration, utilization, and maintenance to expand clinical... Read More →


Wednesday May 19, 2021 12:35pm - 1:25pm EDT

1:30pm EDT

Training on the TMF: How to Clear the Hurdles
  • Review common hurdles in training and TMF Adoption
  • Discuss Re-Training and Keeping it Fresh - How to ensure long term learning and retention
  • Provide Tools and Resources for Success

Speakers
avatar for Laura Hatcher

Laura Hatcher

TMF Lead, Spark Therapeutics
At the beginning of her career in 2010, Laura had her first taste of what a TMF was volunteering to organize data and documents in the ‘paper world’ and was then slowly able to witness the industry evolve to a more digital workspace.  TMF interest grew to lead Laura to her multiple... Read More →


Wednesday May 19, 2021 1:30pm - 2:00pm EDT

2:00pm EDT

"Meet the Speakers" Party
Missing out on the networking aspect of live events? Your question didn’t get answered during the Q&A portion of a session? Grab a snack and mingle with today’s speakers and attendees in these zoom breakout rooms

Wednesday May 19, 2021 2:00pm - 2:30pm EDT
Zoom
 
Thursday, May 20
 

9:30am EDT

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

Jamie Marie Toth, CPM, MS

Senior Director, Clinical Systems & Records, Daiichi Sankyo, Inc.
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... Read More →


Thursday May 20, 2021 9:30am - 9:40am EDT

9:40am EDT

COVID-19: Next Generation of TMF
  • COVID-19: How the daily work has changed
  • What are CA expectations during COVID-19?
  • The future of TMF: Paper vs Electronic
  • Integration with CTMS
  • New Processes to Develop

Speakers
avatar for Donatella Ballerini

Donatella Ballerini

Head of GCP Compliance and Clinical Trial Administration Unit, Chiesi
I started my career in Chiesi almost 11 years ago after some work experiences in different fields and a Master Degree in Touristic Science in Milan.I was involved in the very first line with the big project of a New R&D Center in Parma for Chiesi and I started to work in the Engineering... Read More →


Thursday May 20, 2021 9:40am - 10:10am EDT

10:15am EDT

Discuss Archiving Requirements and eTMF Archiving, and Long-Term Digital Preservation
Moderators
avatar for Jamie Marie Toth, CPM, MS

Jamie Marie Toth, CPM, MS

Senior Director, Clinical Systems & Records, Daiichi Sankyo, Inc.

Speakers
avatar for Lauren Merrill, M.S.

Lauren Merrill, M.S.

Associate Director, Records Management, Biogen
Lauren Merrill is an experienced records and information management professional with more than 15 years in the biopharma industry. She has spent her career focusing on records management in a GXP-regulated environment, helping balance regulations and business needs. She is currently... Read More →
avatar for Chris Jones

Chris Jones

Director, Clinical Documentation, GSK
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 →
avatar for Claire Schenkel

Claire Schenkel

Senior Manager, Clinical Operations System Integrity, Alexion Pharmaceuticals, Inc.
Claire Schenkel joined the TMF industry in 2017, and has experience spanning physical and electronic archiving, TMF digitization and migration, and system implementation. Currently, Claire leads the Clinical Operations System Integrity team at Alexion Pharmaceuticals, where she manages... Read More →


Thursday May 20, 2021 10:15am - 11:00am EDT

11:00am EDT

"Meet the Speakers" Party
Missing out on the networking aspect of live events? Your question didn’t get answered during the Q&A portion of a session? Grab a snack and mingle with today’s speakers and attendees in these zoom breakout rooms

Thursday May 20, 2021 11:00am - 11:30am EDT
Zoom

11:30am EDT

Networking Break
Thursday May 20, 2021 11:30am - 11:55am EDT

11:55am EDT

Afternoon Chairperson’s Introduction
Speakers
avatar for Wendy Beeby

Wendy Beeby

Director, Clinical Document Management and Trial Support, Takeda Pharmacueuticals
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 →
avatar for Grace Crawford

Grace Crawford

Global Head, Clinical Quality & Compliance, AstraZeneca R&D
Grace Crawford is an accomplished quality and compliance leader with over 27 years of experience working with international clinical trials, quality systems, regulatory compliance, and computer systems validation in the pharmaceutical, medical device, and biotech industries across GxP’s (GCP/GLP/cGMP). Her... Read More →


Thursday May 20, 2021 11:55am - 12:00pm EDT

12:00pm EDT

Assessing your TMF’s Health
How do you assess the health of your TMF? Similar to assessing the health of a person, there are a few key components to focus on:
  • Numbers (metrics)
  • Health Habits
  • Health Check-ups
We will review the holistic approach needed for a healthy TMF and then dig deeper into the actual health assessment of the TMF.

Speakers
avatar for LoriAnn Verna

LoriAnn Verna

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 →


Thursday May 20, 2021 12:00pm - 12:30pm EDT

12:35pm EDT

Next Steps to Achieve TMF Completeness
Moderators
avatar for Fiona MacKenzie

Fiona MacKenzie

Manager, TMF and Document Management, Alnylam
Entering the TMF world back in 2010 at what was once INC Research, Fiona spent many hours filing paper records into binders, since then she watched the industry transition from paper to eTMF and been involved in several migrations from paper to eTMF and eTMF to eTMF. Fiona also lead... Read More →

Speakers
avatar for Mark Choe

Mark Choe

eTMF SME, Inspection Readiness Expert, Veeva eTMF Analytics Expert, Clinical Process Alignment SME, Independent
avatar for Christa Lewiski

Christa Lewiski

TMF Head, Study File Manager, Seqirus
Christa Lewiski is the TMF Head, Study File Manager at Seqirus for the last 3 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 Wendy Koc

Wendy Koc

Associate Director, R&D, Quality and Compliance, Gilead
Wendy Koç has been working in pharma GCP QA for nearly 30 years. She has worked across all areas of clinical trials in pharma, CRO and as a consultant and during this time the TMF as always been a focus of interest.  Wendy currently work closely with the TMF team at Gilead... Read More →


Thursday May 20, 2021 12:35pm - 1:25pm EDT

1:30pm EDT

Quality Control of the Trial Master File
  • Understanding quality control
  • Implementing V3.2 of the TMF Reference Model
  • Introducing some different TMF metrics for TMF QC

Speakers
avatar for Daniel Bennett

Daniel Bennett

TMF Manager, Independent
Daniel has worked in various TMF roles for large pharma companies and small biotech, with a full-service CRO and a niche TMF provider. Having seen the issues from all sides he is a convert to the idea that the TMF is a key part of a quality approach to clinical trial management. He... Read More →


Thursday May 20, 2021 1:30pm - 2:00pm EDT

2:00pm EDT

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

Jamie Marie Toth, CPM, MS

Senior Director, Clinical Systems & Records, Daiichi Sankyo, Inc.
avatar for Wendy Beeby

Wendy Beeby

Director, Clinical Document Management and Trial Support, Takeda Pharmacueuticals
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 →
avatar for Grace Crawford

Grace Crawford

Global Head, Clinical Quality & Compliance, AstraZeneca R&D
Grace Crawford is an accomplished quality and compliance leader with over 27 years of experience working with international clinical trials, quality systems, regulatory compliance, and computer systems validation in the pharmaceutical, medical device, and biotech industries across GxP’s (GCP/GLP/cGMP). Her... 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... Read More →


Thursday May 20, 2021 2:00pm - 2:15pm EDT

2:15pm EDT

"Meet the Speakers” Party
Missing out on the networking aspect of live events? Your question didn’t get answered during the Q&A portion of a session? Grab a snack and mingle with today’s speakers and attendees in these zoom breakout rooms

Thursday May 20, 2021 2:15pm - 2:45pm EDT
Zoom