North Wales, Pennsylvania

 26th September 2019

A Regulatory Submission Cross-functional Walk-through


The North Wales SDE was hosted by Merck on 26th September. Changhong Shi, Merck and Hima Bhatia, ICON were the SDE Chairs. The theme for the SDE was “A Regulatory Submission Cross-functional Walk-through”, and over 110 people from various biopharmaceutical and CRO companies were present at the event.

Amy Gillespie, Merck delivered excellent keynotes, where she also addressed how attendees can reap the benefits of PHUSE SDEs by learning today, sharing tomorrow and innovating and inventing in the future. The event kicked off with a valuable talk about regulatory submissions including a presentation from the FDA representative about the Technical Rejection Criteria for Study Data.

During the coffee breaks and lunch, the delegates had the chance to glance at the posters and listen to other attendees’ perspectives in the submission area. After lunch, Suhas Sanjee gave an update on ongoing and upcoming PHUSE happenings. After the PHUSE updates, the session continued with informative presentations on Regulatory Review of Data Submission Packages and Why Should We Care About the electronic Common Technical Document in the Submission Process.
During the panel discussion, all the speakers were invited up to the front to discuss the following topics with the attendees: ARM (PMDA, FDA), data standards, SEND and metadata automation.

Overall, the event was excellent! This would not have been possible without our terrific presenters, volunteers, sponsors and attendees.



Welcome Slides

Analysis Package e-Submission – Planning and Execution – Saigovind Chenna, Merck

Metadata-driven Automation for Standard Safety Analysis – Beilei Xu, Sanofi

Technical Rejection Criteria for Study Data – Heather Crandall, FDA

Industry Experiences Submitting Standardized Study Data to Regulatory Authorities – Janet Low and Kiran Kundarapu, Merck

RTOR Pilot – Ketan Durve, Janssen Research & Development

The Drive to Incorporate Standardized nonclinical Data into Regulatory Submissions Through Collaboration – Catherine Roy, Matthew Bendekovits and Janessa Pierce, Merck

Value-added Validation: Regulatory Review of Data Submission Packages – Mary Anne Potok, MMS

Why Should We Care About the eCTD (electronic Common Technical Document) in the Submission Process? – Kevin Lee, Clindata Insight


(i) All Aspects on BIMO – Chunying Yin, Janssen Research & Development
(ii) Best Practices for Submission of Event Adjudication Data – Joanne Zhou etc., GlaxoSmithKline
(iii) Implementing Traceability in CDISC-compliant Studies – Shunbing Zhao and Changhong Shi, Merck
(iv) Submission Checklist from an ADaM Perspective – Yi Zhao, Merck
(v) What You Need to Know about Submitting Data to the FDA – Pritesh Solanki and Janet Low, Merck

View the event brochure.





Photos of the day:


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