TMF Virtual Summit: Full Schedule

11:55am EDT

Afternoon Chairperson’s Introduction

Speakers

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 →

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

TMF Collaboration

12:00pm EDT

Utilizing Technology to Minimize Inspection Risk During M&A

Speakers

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 →

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

TMF Collaboration

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

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

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 →

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 →

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 →

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

TMF Collaboration

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

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

TMF Collaboration

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

TMF Collaboration