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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

Speaker

Olga Alfieri, MBA, MSc, RAC

Eisai Pharmaceuticals, United States

Senior Director, Global Submission Management & Operations

Jillian E. Carinci, MS

Successful Practices for Regulatory Collaborations

Jillian E. Carinci, MS

Biogen, United States

Senior Director, Head of Submission Sciences

Nancy Pire Smerkanich, DrSc, MS

Speaker

Nancy Pire Smerkanich, DrSc, MS

University of Southern California School of Pharmacy, United States

Assistant Professor Regulatory & Quality Sciences

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