GlobalSubmit Presenters
Jason Rock, Chief Technical Officer
Jason Rock is a pioneer in the field of electronic submissions. Mr. Rock has an extensive background working with global life science companies and regulatory agencies to promote eCTD adoption through the development of advanced applications.
Evan Richardson, Director, Regulatory Services
Evan Richardson brings 10 years of experience in regulatory affairs and operations to GlobalSubmit. His experience includes stints with pharmaceutical, biotechnology, and medical device companies, where he's specialized in project management, system implementation, eCTD submissions, and organizational training
Join GlobalSubmit, a leading provider of eCTD regulatory publishing services and software technology, as we discuss regulatory publishing best practices for eCTD submissions at The Frontier in Research Triangle Park. The event is scheduled for Thursday, September 22, 2016 starting at 3 p.m.
Presentation Agenda
1. Introduction of GlobalSubmit Regulatory Services
- Case Study #1 - Transitioning a paper IND to eCTD
- Case Study #2 - Meeting Submission Deadlines with Last-Minute Changes
2. Preview of New FDA Validation Specifications
3. Q&A on eCTD v4 with RPS Project Lead Jason Rock
4. Happy Hour at The Frontier