Free Educational Webinar: Reasons to Switch to eCTD
Update: the webinar slides are now available for download here.
The eCTD format continues to grow as the standard for regulatory submissions worldwide, and the FDA has made it very clear that it prefers to receive submissions in eCTD format. However, when many smaller biotech and pharma companies reach the IND or NDA/BLA stages, they still often consider paper submissions as a viable option.
Featured topics include:
- Pros & cons for making the switch from paper to eCTD submissions
- Why eCTD submissions are the best choice for any sponsor
- Real-world case studies of the benefits of eCTD submissions
About Evan Richardson, B.S., R.A.C., Associate Director, Regulatory Operations, Cato Research
Mr. Richardson has been preparing regulatory submissions at Cato Research since 2006. As the Associate Director, Regulatory Operations, he leads a team of specialists who prepare more than 300 regulatory submissions to the FDA each year.
Mr. Richardson has compiled over 350 submissions to the FDA, including work on over a dozen eCTD Investigational New Drug Applications (INDs) and five marketing applications, four of which have been approved by the FDA to date.
Mr. Richardson regularly authors articles on regulatory submissions for Cato Research’s blog, Ask-Cato.com, and has been featured as a guest author at PharmPro.com and The eCTD Summit, the official blog of GlobalSubmit. Mr. Richardson is a member of the Regulatory Affairs Professionals Society and is Regulatory Affairs Certified (RAC). He is also a member of the Drug Information Association and is an active participant in the eCTD group of the NC Regulatory Affairs Forum.
When: Wednesday, July 13th at 12pm EDT
Where: Web & Teleconference
Who: Moderator, Jason Rock, CTO, GlobalSubmit and Evan Richardson, B.S., R.A.C., Associate Director, Regulatory Operations, Cato Research
For more information and event details: GlobalSubmit Events