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Bethesda North Marriott Hotel and Conference Center

Feb 06, 2017 7:00 AM - Feb 08, 2017 5:00 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Session 6 Track 1: Save $60 Million – The Easy Way

Session Chair(s)

Brooke  Casselberry, MS, RAC

Brooke Casselberry, MS, RAC

Vice President, Advisory and Delivery

Epista Life Sciences, United States

During this session we will explore the rounded experience of regulatory platform integration beginning with the RFP process, product selection, and change management, to go-live. You will learn useful tips in RFP development and execution, case-study in regulatory platform solution selection process, and change management engagement practices for successful implementation.

Learning Objective : - Attendees will get a unique perspective on the technology for regulatory information from a case study of someone on both sides of the equation - Attendees will be tasked with a thought experiment and exploration of alternatives - Attendees will have the opportunity to streamline by setting a new standard deliverable for all Regulatory Software Vendors

Speaker(s)

Matt  Neal, MA

Speaker

Matt Neal, MA

Atara Biotherapuetics, United States

Senior Director, Regulatory Affairs Operations

Brooke  Casselberry, MS, RAC

Speaker

Brooke Casselberry, MS, RAC

Epista Life Sciences, United States

Vice President, Advisory and Delivery

Karin  Schneider, MLIS, MS

Speaker

Karin Schneider, MLIS, MS

Johnson & Johnson Innovative Medicines, United States

Associate Director

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