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Regulatory Submissions, Information, and Document Management Forum

Session 4 Track 4: Publishing Pet Peeves and Practical Pointers

Session Chair(s)

Stacy  Tegan

Stacy Tegan

  • Senior Program Manager
  • 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


Olga  Alfieri, MBA, MSc, RAC


Olga Alfieri, MBA, MSc, RAC

  • Director, Global Submission Management
  • Eisai Pharmaceuticals, United States
Jillian E. Carinci, MS

Successful Practices for Regulatory Collaborations

Jillian E. Carinci, MS

  • Director, Submission Sciences
  • Biogen, United States
Nancy Pire Smerkanich, DrSc, MS


Nancy Pire Smerkanich, DrSc, MS

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