Trial Master File Summit 2021 has ended
Workshop Day - In-Person Only [clear filter]
Monday, October 25

9:00am CDT

TMF Management Plan Workshop
avatar for Marion Mays

Marion Mays

Vice President, Expert Services and Consulting Solutions, PHLEXGLOBAL
Marion Mays in an industry leader in Information Management with over 28 years of experience in the Pharmaceutical industry.  An advocate for essential information management practices; competent training for all contributors and consumers of the documentation which supports the... 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 →

Monday October 25, 2021 9:00am - 12:00pm CDT

1:00pm CDT

Turning Your Processes and Systems into Strategic Assets
How to turn your TMF Management processes and systems into a strategic asset instead of an afterthought. This workshop will discuss best practices in identifying compliance and operational inefficiency gaps in TMF processes and technology. This workshop will include strategies for leveraging gap assessment data to gain leadership support for optimization. Discuss approaches to ensuring that your business processes and technology align with an emphasis on prioritization, optimization, and ultimately systems implementations.

avatar for Donna Dorozinsky

Donna Dorozinsky

President/CEO, Just in Time GCP
30 years experience in drug development and clinical compliance, Founded Just in Time GCP in 2005, Extensive experience in supporting organizations through successful regulatory inspection preparation.
avatar for Jamie O’Keefe

Jamie O’Keefe

VP, Business & Technology, Just in Time GCP
20 years of business and technology consulting expertise, leading large scale, and biotech transformation programs, with a focus on Clinical Operations.

Monday October 25, 2021 1:00pm - 4:00pm CDT
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