North Wales, Pennsylvania

 26th September 2019


Registration:

This event has now reached capacity.
Contact the PHUSE Office for further information.

Theme:

A Regulatory Submission Cross-functional Walk-through

 

Description:

The delivery of a successful NDA submission requires a great deal of cross-functional effort. It is critical that the deliverables from this process conform to industry standards and regulatory requirements. It is also critical that submission teams work efficiently and effectively to meet the timelines while delivering a quality submission. A walk-through of the submission from different perspectives including data management, biostatistics & programming, medical writing, pharmacovigilance and regulatory operations at this SDE will produce profound insights. Participants and attendees of this SDE will walk away with a better understanding of where they fit into the overall submission process. Hearing others’ perspectives will give attendees ideas to improve this collaborative effort for the next submission, or at the very least, give them a better understanding of the process in general.

 

Location:

Merck Upper Gwynedd Site

The UG Auditorium UG-1B109

351 N  Sumneytown Pike

North Wales, PA 19454

 

Agenda:

Time Presentation Speaker(s)
08.30–09.15 Registration and Light Breakfast
09.15–09.30 Welcome Amy Gillespie,
Merck
09.30–10.00 Analysis Package e-Submission – Planning and Execution Saigovind Chenna,
Merck
10.00–10.30 Metadata-driven Automation for Standard Safety Analysis Beilei Xu,
Sanofi
10.30–11.00 Coffee Break
11.00–11.30 Technical Rejection Criteria for Study Data Heather Crandall,
FDA
Via video conference
11.30–12.00 Industry Experiences Submitting Standardized Study Data to Regulatory Authorities Janet Low and Kiran Kundarapu,
Merck
12.00–12.10 Poster Introduction

(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

12.10–1.00 Lunch Break
1.00–1.15 PHUSE Updates Chris Hurley,
PHUSE Americas Director
1.15–1.45 RTOR Pilot Ketan Durve,
Janssen Research & Development
1.45–2.15 The Drive to Incorporate Standardized nonclinical Data into Regulatory Submissions Through Collaboration Catherine Roy, Matthew Bendekovits and Janessa Pierce,
Merck
2.15–2.45 Coffee Break
2.45–3.15 Value-added Validation: Regulatory Review of Data Submission Packages Mary Anne Potok,
MMS
3.15–3.45 Why Should We Care About the eCTD (electronic Common Technical Document) in the Submission Process? Kevin Lee,
Clindata Insight
3.45–4.00 Q&A and Closing Remarks All presenters

 

SDE Chairs:

Changhong Shi, Merck

Hima Bhatia, ICON

If you have any questions, or require any information, please contact one of the SDE Chairs.
 

Sponsors:

     

If you are interested in sponsoring this event, click here.

 

Hotels:

Homewood Suites by Hilton Lansdale
 
Normandy Farm Hotel and Conference

 

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