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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

  • Associate Director, Program Management
  • 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 : 1. Discuss Emerging Markets Submission Regional Requirements for Getting it Right First Time (GIRFT) for preparing eCTD and global dossier to Emerging Markets such as Australia, Qatar, Bahrain, Saudi Arabia, Switzerland, Thailand, China, etc. to ensure submission readiness. 2. Establishing an end-to-end process for emerging market countries filing strategy based on lessons learned.

Speaker(s)

Olga  Alfieri, MBA, MSc, RAC

Speaker

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

Speaker

Nancy Pire Smerkanich, DrSc, MS

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