North Wales, Pennsylvania

 September 2019

 

 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.

 

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:

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.
 

Sponsor:

 

     

           

 

 

 

 

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

 

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1. Register online.

2. Contact memberships@phuse.eu for group membership applications or for invoicing arrangements.

 

   

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