Back to Agenda
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)
Joel Finkle
Industry Expert, Retired, United States
eCTD 4.0 – We’re Ready Already
Frank Dickert
Senior Business Consultant, EXTEDO Gmbh, Germany
eCTD 4.0: No Need to be Afraid
Daniel Smith
Senior Regulatory Information Management Consultant, Calyx, United Kingdom
Looking Towards the Future of eCTD
Sarah Pope Miksinski, PHD
Executive Director, CMC Regulatory Affairs, Gilead Sciences, United States
ICH Update: Progress on M4Q
Have an account?