Free Educational Webinar: FDA Review Process

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Update: the webinar slides are now available for download here.

Navigating eCTD regulations and guidelines is easier said than done. Same goes for assembling and reviewing applications. That’s why GlobalSubmit and Cato Research are offering a free educational webinar on the FDA Review Process on Tuesday, March 1st at 3pm EST.

The purpose of this webinar is to provide you with the complete FDA review process to make sure that you are able to create an application that is technically sound and also structured correctly. Most importantly, it must be ready for review by the agency upon submission.

Featured topics include:

The various steps and stages that a drug application goes through in order to be approved by the FDA and marketed in the U.S.

The FDA’s workflow, the challenges they face in the electronic submission process and common errors in a submission.

The importance of using validation software when submitting your eCTD to ensure that your submission will not be rejected due to a technical error.

GlobalSubmit Inc., a leading developer of eCTD review and validation software for FDA use, is aware that technical issues can prevent your INDs, NDAs, etc. from being approved by the FDA. Our close relationship with the FDA has provided us the experience and expertise to help.

About Jason Rock, Chief Technology Officer, GlobalSubmit

Mr. Rock is a technology visionary and leader within the eCTD community at large. He has over 10 years of experience working with global life sciences companies and regulatory agencies to promote the adoption of the eCTD through the development of advanced applications.

In his role as CTO, Mr. Rock provides strong leadership for the strategic and technical direction of GlobalSubmit’s product architecture and development. He is a frequent guest speaker at numerous industry forums such as DIA, RAPS and others. Mr. Rock chairs the HL7 Regulated Product (RPS) initiative and works closely with the U.S. FDA for their deployment of GlobalSubmit applications as well as various technology programs involving regulatory submissions.

Event Details
When: Tuesday, March 1st at 3 pm EST
Where: Web & Teleconference
Who: Jason Rock, Chief Technology Officer at GlobalSubmit and Evan Richardson, Associate Director Regulatory Operations at Cato Research

For more information and to register: Cato Research Events

Author: GS

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