Session 7 Track 4: It's All About the Data! From Case Report Forms to Datasets, what does FDA need to Approve your Submission?
Evan Richardson |Director, Regulatory Services
Years of product development, intricate planning of study execution, patients serving as study participants – it all comes down to the data. Electronic submissions bring the journey of the data to life for reviewers. It starts with recording the data. Learn how to overcome challenges of incorporating Case Report Forms into “reviewer friendly" submissions while balancing the need for efficiency. Study data then has to be tabulated and analyzed. With the best practices to be shared in this session, publishing CDISC compliant datasets will no longer be an intimidating process. Once that data arrives at FDA, it must pass validation to make it to the reviewer. Learn about the new validation criteria put into effect in September 2021, common reasons for rejection, and tools to help avoid these errors. Once submitted, FDA must assure the quality and integrity of the data. Learn about CDER’s Bioresearch Monitoring (BIMO) program’s requirements for new marketing applications.
Session Chair: Rob Labriola |Sr. Director, Regulatory Services
It’s been seven years since Health Level Seven (HL7) approved the Regulated Product Submissions (RPS) standard, and six since ICH approved it to Step 4 as the basis for eCTD 4.0. Various reasons, from software updates to COVID-19, have kept it from being implemented, with only Japan reaching the pilot stage. So, what are we missing out by not having it? We will share the value and benefits software vendors, health agencies and drug sponsors will gain by moving forward with eCTD 4.0. Learning Objective : At the conclusion of this session, participants should be able to: Identify the basics of eCTD 4.0 Plan for eCTD 4.0 timelines and prepare colleagues in your organization for eCTD 4.0 Implement changes to your regulatory daily business due to eCTD 4.0 Recognize the value and the promise of more efficient reviews of submissions