North Wales, Pennsylvania

 26th September 2019

Registration will open in the middle of August.



 All PhUSE Single Day Events are FREE to members. To become a member click here. Registrations per company are limited to 20% of maximum attendance.



A Regulatory Submission Cross-functional Walk-through



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.



Merck Upper Gwynedd Site

The UG Auditorium UG-1B109

351 N  Sumneytown Pike

North Wales, PA 19454


Call for Speakers:

We are now calling for speakers to present at this event.

To submit an abstract or for more information, please contact the SDE Chairs (below).

Presentations should surround the theme of the event: 'A Regulatory Submission Cross-functional Walk-through'


New for the North Wales SDE 2019, we would like to hold a poster session during the breaks, giving you the opportunity to present and discuss topics close to you. If you are interested in submiting a poster for this event, please contact the Chairs below for further information and requirements.


Deadline: Friday 28th June 2019



To follow.


SDE Chairs:

Changhong Shi, Merck

Hima Bhatia, ICON

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








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