26th April 2018
Registration will open soon.
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Registrations per company are limited to 20% of maximum attendance.
Practical Experience With Electronic Submissions
FDA and PMDA require standardized study data for certain regulatory submissions. These requirements officially went into effect for studies starting in December 2016 and after. The regulators have been very transparent sharing their experiences processing and reviewing standardized study data. Furthermore, the regulators have been diligent in their efforts to clarify and document their expectations for industry. For example, the FDA publishes quarterly updates to the Study Data Technical Conformance Guide.
Although industry has been operationalizing CDISC standards across the study life-cycle for the better part of a decade, regulatory submissions of CDISC data remain a nerve-wracking dash to the regulator's gateway. After calming nerves, the requisite lessons learned meetings occur. Maybe those lessons are applied within a company. Maybe, those lessons find their way into an abstract for a presentation at a conference like PhUSE Connect. Unfortunately, in most cases, those lessons are forgotten until the next nerve-wracking submission. A PhUSE Working Group project has sought to change that paradigm and provide a forum for industry to share submission experiences.
This event builds upon those efforts and focuses on practical experience with standardized study data submissions. Thought leaders who have been through at least one CDISC submission will share their experiences and lessons learned. The goal of this event is for you to take away one lesson that you can apply.
Call for Speakers:
If you are interested in presenting and sharing your insights and experience on the event theme, please contact the Co-Chairs below.
Todd Case, Vertex
Scott Bahlavooni, d-Wise
If you have any questions, or require any information, please contact the SDE Chair.
If you are interested in sponsoring this event, click here.
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