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Session 8 Track 4: eCTD Future
Session Chair(s)
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)
eCTD 4.0 – We’re Ready Already
Joel Finkle
Retired, United States
Industry Expert
eCTD 4.0: No Need to be Afraid
Frank Dickert
EXTEDO Gmbh, Germany
Senior Business Consultant
Looking Towards the Future of eCTD
Daniel Smith
Calyx, United Kingdom
Senior Regulatory Information Management Consultant
ICH Update: Progress on M4Q
Sarah Pope Miksinski, PhD
Gilead Sciences, United States
Executive Director, CMC Regulatory Affairs