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Bethesda North Marriott Hotel and Conference Center

Feb 10, 2020 11:00 AM - Feb 12, 2020 2:15 PM

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

Regulatory Submissions, Information, and Document Management Forum

Session 9 Track 4: Quality and Speed to Submission - Process is the Key for These to Coexist!

Session Chair(s)

Daniel  Orfe, MS

Daniel Orfe, MS

President and CEO

Regulatory eSubmissions, LLC, United States

Speed to patient is a fundamental concept in the regulatory and submissions world. When crunch time hits, it appears inevitable that the submissions team is asked how to make the submission process move faster and that request typically follows with little budgetary support. Planning for electronic common technical document (eCTD) submissions can seem like a complex and confusing process. Key drivers for speed to submissions are the right building blocks: clear processes and high quality. There are a few critical steps companies need to take to make this process run smoothly. Taking time to ensure submissions are completed properly and formatted correctly, the first time is imperative. If any of these steps are overlooked, submissions can take longer, cost more, and impact future lifecycle submissions. This session will evaluate and discuss the importance of quality improvement programs in regulatory departments. Best practices for tracking metrics will be reviewed. Acknowledging the difficulties of implementing change, effective change management strategies that allow regulatory departments to work through process changes will be explored. The advent of AI and how it is affecting (if at all) regulatory groups will be examined.

Learning Objective :

At the conclusion of this session, participants should be able to:

  • Review development plan and process for continuous improvement
  • Develop training plan to ensure high quality submission
  • Learn the few critical steps companies need to take to make what appears to be the complex and confusing process of planning electronic common technical document submissions run smoothly


Laurie  Henricks

Six Keys to Successful eCTD Regulatory Submission

Laurie Henricks

Arena Pharmaceuticals, Inc., United States

Sr Director, Regulatory Operations

Sandra  Krogulski, MA

Speed to Submission: Process and Quality

Sandra Krogulski, MA

Bristol-Myers Squibb Company, United States

Director, GRSO Innovation and Business Operations Lead

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