Free Educational Webinar: Preparing for the eCTD mandate
The FDA is planning to mandate electronic submissions in 2014. Since most large pharmaceutical and biotech companies already submit electronically, the greatest impact will be to the smaller companies that do not have substantial IT infrastructure in place and lack the resources of their larger peers.
Jason Rock, Chief Technical Officer at GlobalSubmit, will provide greater insight into this topic during a free educational webinar entitled, Preparing for the eCTD Mandate, on Wednesday, February 27th at 12:00 p.m. EST.
During this discussion, Jason will discuss the implications that PDUFA V will have on regulatory submissions, in particular the mandate to convert all regulatory submissions to eCTD. By the end of this interactive session, you will have the information necessary to effectively prepare your organization for the impending mandate.
Top 3 Learning Objectives:
1. Understand PDUFA V’s repercussions on regulatory submissions
2. Learn the steps needed to move from paper to electronic submissions (eCTD)
3. Realize the advantages of direct communication with the FDA during the approval process
Jason Rock, CTO at GlobalSubmit
Click here to Register