Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join

Bethesda North Marriott Hotel and Conference Center

Feb 08, 2016 12:00 PM - Feb 10, 2016 5:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Discuss the end-to-end process for document management, publishing, and technical regulatory requirements in regulatory information management.

Session 4 Track 2 - eCTD v4/RPS; Moving Towards Implementation

Session Chair(s)

Mark A. Gray

Mark A. Gray

Senior Project Manager, DSB, CBER

FDA, United States

Now that the Regulated Product Submission (RPS) Release 2 is a normative standard and the International Council for Harmonisation (ICH) is finalizing the eCTD v4 implementation package, the focus is now on preparing for the implementation of eCTD v4. Based on the Health Level Seven (HL7) RPS exchange message, eCTD v4 is more than just a different backbone. eCTD v4 includes more submission metadata, new life cycle functionality, document reuse, and support for the exchange of information between regulatory authorities and sponsors. This session will provide information on the development and benefits of eCTD v4 but will also address the impact of the new standard and provide an update on the implementation process to prepare for the transition to eCTD v4.

Learning Objective : Presenters will explain the relationship between RPS and eCTD v4.0, their scope, and their development history including implementation plans. Participants will be able to map existing eCTD terms and concepts to their RPS counterparts, recognize additional functionality and benefits, recognize controlled vocabularies and who manages them, and start preparing for the transition to eCTD v4.0.


Jared  Lantzy, PMP

eCTD v4.0: The Path to Implementation

Jared Lantzy, PMP

Booz Allen Hamilton, United States

Lead Associate

Joel  Finkle

eCTD 4 is Sneaking Into Your Submissions Processes

Joel Finkle

Retired, United States

Industry Expert

Hitoshi  Matsui

What is the Impact to the Current Regulatory Information System?

Hitoshi Matsui

CAC Corporation, Japan


Have an account?

Be informed and stay engaged.

Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events.