eCTD Review

Webinar Recap: Intro to eCTD

GlobalSubmit recently held an educational webinar entitled Intro to eCTD. Under the draft PDFUA V bill, electronic submissions will be mandated in Q2 2015. Given this recent news, GlobalSubmit offered this free webinar to provide a comprehensive overview of the eCTD, including everything from basics and terminology to rules and regional standards to submission output and solutions, and more. If… Read more →

Free Webinar: Intro to eCTD

As you may already know, under the draft PDFUA V bill, electronic submissions will be mandated in Q2 2015. Are you prepared? Navigating eCTD regulations and guidelines is easier said than done. Same goes for assembling and reviewing applications. Your application must be technically sound and structured correctly. Most importantly, it has to be ready for review by the agency… Read more →

Webinar Recap: Understanding the New FDA Validation Criteria

GlobalSubmit recently held an educational webinar on the Understanding the New FDA Validation Criteria. The purpose of the webinar was to provide an overview of the US FDA’s draft version of the new “Specification for eCTD Validation Criteria,” which outlines many of the new error conditions that the FDA will be checking for in the next version of its validation software. During… Read more →

Regulatory Submissions Made Easy, Part II

Today’s entry was provided by Matthew J. Neal, Director of Knowledge Management & Innovation in Global Regulatory Affairs & Safety at Amgen, Inc. in Thousand Oaks, CA.  He led the Regulatory Operations group there for seven years and managed submissions for GSK in Philadelphia, PA for 7 years before that. So, last time, I told you about assembling a team of… Read more →

Regulatory Submissions Made Easy, Part I

Today’s entry was provided by Matthew J. Neal, Director of Knowledge Management & Innovation in Global Regulatory Affairs & Safety at Amgen, Inc. in Thousand Oaks, CA.  He led the Regulatory Operations group there for seven years and managed submissions for GSK in Philadelphia, PA for 7 years before that.     Did that title catch you?  Did you think I… Read more →