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Bethesda North Marriott Hotel and Conference Center

Feb 14, 2022 8:30 AM - Feb 16, 2022 2:15 PM

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

Regulatory Submissions, Information, and Document Management Forum

Session 8 Track 4: eCTD Future

Session Chair(s)

Rob  Labriola, MS

Rob Labriola, MS

Exec. Director, Regulatory Operations

Garuda Therapeutics, United States

It’s been seven years since Health Level Seven (HL7) approved the Regulated Product Submissions (RPS) standard, and six since ICH approved it to Step 4 as the basis for eCTD 4.0. Various reasons, from software updates to COVID-19, have kept it from being implemented, with only Japan reaching the pilot stage. So, what are we missing out by not having it? We will share the value and benefits software vendors, health agencies and drug sponsors will gain by moving forward with eCTD 4.0.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Identify the basics of eCTD 4.0
  • Plan for eCTD 4.0 timelines and prepare colleagues in your organization for eCTD 4.0
  • Implement changes to your regulatory daily business due to eCTD 4.0
  • Recognize the value and the promise of more efficient reviews of submissions

Speaker(s)

Joel  Finkle

eCTD 4.0 – We’re Ready Already

Joel Finkle

Retired, United States

Industry Expert

Frank  Dickert

eCTD 4.0: No Need to be Afraid

Frank Dickert

EXTEDO Gmbh, Germany

Senior Business Consultant

Daniel  Smith

Looking Towards the Future of eCTD

Daniel Smith

Calyx, United Kingdom

Senior Regulatory Information Management Consultant

Sarah  Pope Miksinski, PhD

ICH Update: Progress on M4Q

Sarah Pope Miksinski, PhD

Gilead Sciences, United States

Executive Director, CMC Regulatory Affairs

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