April 26th 2018
Practical Experience with Electronic Submissions
The 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 the industry. For example, the FDA publishes quarterly updates to the Study Data Technical Conformance Guide.
Although the 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 the 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.
Welcome & Introduction to Keynote – Mei-Hsiu Ling and Bo Yang, Vertex
A Framework for Implementing Evolving FDA Guidance – Todd Case, Vertex
CDISC Submissions: A CRO Perspective – Bhavin Busa, Vita Data Sciences
Hands-on with the Analysis Data Reviewer’s Guide – Shailendra Phadke, Shire
PHUSE Working Groups Update – Scott Bahlavooni, PHUSE Working Groups Director
Trials and Tribulations: Experiences Using Data Standards and Assisting Staff in Reviewing Submissions – Dr. Jeffry Florian, FDA
Standardized Data Sample Submissions: The Key to Improving the Regulatory Submission Strategy – Joanna Koft and Prafulla Girase, Biogen
Perfecting the Game Plan: The Hand-off from Programming and Stats to Regulatory Operations – Mary Anne Potok, MMS
View the event brochure.