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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 4 Track 4: Publishing Pet Peeves and Practical Pointers

Session Chair(s)

Stacy  Tegan

Stacy Tegan

Program Director, Transcelerate Biopharma Inc., United States

Electronic submissions have been standard practice for many years, but that does not mean submission preparation is standard! This will be an interactive, discussion-based session to go beyond slide presentations and into the nitty gritty, real world challenges faced in publishing. Hear from "been there done that" experts. Bring questions for our panelists representing big pharma, small biotech, and outsource publishing vendor experience. Come to learn and come to share - your participation will help make this an engaging exchange of ideas and learnings.

Learning Objective : Discuss detailed challenges of publishing to meet today's electronic submission requirements. Describe common pitfalls and how to avoid them

Speaker(s)

Olga  Alfieri, MBA, MSC, RAC

Olga Alfieri, MBA, MSC, RAC

Senior Director, Global Submission Management & Operations, Eisai Co., Ltd., United States

Speaker

Jillian E. Carinci, MS

Jillian E. Carinci, MS

Senior Director, Head of Submission Sciences, Biogen, United States

Successful Practices for Regulatory Collaborations

Nancy Pire Smerkanich, DRSC, MS

Nancy Pire Smerkanich, DRSC, MS

Assistant Professor Regulatory & Quality Sciences, University of Southern California School of Pharmacy, United States

Speaker

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