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Wednesday, June 29 • 2:00pm - 3:00pm
#341: eTMF: Selection, Implementation, and What's Next?

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Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

This session will walk through the steps from vendor selection to global implementation of an eTMF software and associated services - both as a general approach and a case study for a top ten pharmaceutical company. It will elaborate on the various workstreams established to ensure success.

Learning Objectives

Describe the hurdles to successful global implementation of an eTMF; Discuss the importance of a robust TMF structure; Recognize that an eTMF is not about the software, its about the processes and workflows.


Karen Jane Roy, MPharm


eTMF: Challenges and Possible Solutions
Laxman Kumar Jakkala, SR, PhD

Global Implementation of a Full Service Provision eTMF Software and Services: A Case Study
Martina M Duevel, DrSc

avatar for Karen Roy

Karen Roy

Senior Vice President, Client Solutions, Phlexglobal
Karen entered the Pharmaceutical Industry working in sales with Eli Lilly. In 1992, she moved to Chiltern International, initially managing the Clinical Development Department and later a new group, EDC Solutions. Karen joined Phlexglobal in 2007 as Chief Business Development Officer... Read More →


Martina Duevel

Senior GCPM ONC, eTMF Process Owner Representative, Bayer Pharma AG
Dr. Martina Duevel eTMF Process Owner Representative, Bayer In the pharmaceutical industry for 16 years with roles in QA and Clinical Project Management. Project Lead for eTMF implementation and maturation, and Process Owner Representative for internal oversight and vendor govern... Read More →

Laxman Jakkala

Director, Global Quality Assurance, MakroCare

Wednesday June 29, 2016 2:00pm - 3:00pm
204B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA