North Wales, Pennsylvania
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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
Changhong Shi, Merck
Hima Bhatia, ICON
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