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Bethesda North Marriott Hotel and Conference Center

05 feb 2018 7:00 a.m. - 07 feb 2018 3:00 p.m.

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

Regulatory Submissions, Information, and Document Management Forum

Session 7 Track 4: Keeping up with Trends in eCTD: Submitting in US Module 1 Specification

Session Chair(s)

Peter  Terbeek, MBA

Peter Terbeek, MBA

Senior Director, Regulatory Operations

United States

This session will explore the good, the bad and the ugly of transitioning to the new US Module 1 Specification. We will examine considerations and obstacles for converting and hear from a vendor on how to support a mixed portfolio. We will cover software and validation considerations, training to understand the regulatory changes, and US M1 metadata and new document fields. This session will encourage your participation by asking questions and polling your experiences.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Understand the benefits and differences in the new US module 1 specifications
  • Identify strategies to implement the new US module 1 specification within their organization

Speaker(s)

Greg John May

Transitioning to ECTD, a Small Company Perspective

Greg John May

Nabriva Therapeutics, United States

Assistant Director, Regulatory Affairs

Jennifer  Moore

Managing a Global Portfolio, a Large Company Perspective

Jennifer Moore

Amgen, Inc., United States

Manager, GRAAS Ops Publishing

Sandra  Krogulski, MA

Supporting Multiple Specifications Simultaneously, a Vendor Perspective

Sandra Krogulski, MA

Bristol-Myers Squibb Company, United States

Director, GRSO Innovation and Business Operations Lead

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