返回 Agenda
Session Chair(s)
Susan Vintilla-Friedman
Consultant, Regulatory and Medical Writing
Self, United States
Learning Objective : At the conclusion of this session, participants should be able to: - Identify recent FDA requirements for electronic submissions that are relevant to your organization - Define strategies for increased communication with FDA and other stakeholders during the submission proces - Discuss new tools and processes needed for successful electronic submissions
Speaker(s)
Faculty
Susan Vintilla-Friedman
Self, United States
Consultant, Regulatory and Medical Writing
Faculty
Antoinette Azevedo
RegDocs365, United States
Co-Founder
Faculty
Mitchell Seymour, PHD, RAC
Biohaven Pharmaceuticals, United States
Principal/Founder; Lead, Regulatory Operations