In this free webinar, gain insights into the constantly evolving data standards requirements for regulatory submissions. The US Food and Drug Administration (FDA) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) delineate these requirements through binding guidance documents, technical specifications and other reference documents collaboratively developed with industry consortiums. This webinar will provide a comprehensive overview of the diverse requirements and guidance on interpreting them. The featured speakers will conduct a practical analysis that compares FDA requirements with those of the PMDA in the context of data standardisation requirements within a submission package to provide attendees with useful insights and more.
TORONTO, March 6, 2024 /PRNewswire-PRWeb/ -- Data standards requirements for regulatory submissions are constantly evolving. The US Food and Drug Administration (FDA) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) delineate these requirements through binding guidance documents, technical specifications and other reference documents collaboratively developed with industry consortiums.
Periodic updates introduce nuanced modifications to these standards and add to the challenge of navigating this dynamic regulatory landscape. This webinar provides a comprehensive overview of the diverse requirements and guidance on interpreting them.
The featured speakers share best practices and resources for attendees to discover further information and templates to facilitate the preparation of submission data packages that align with regulatory expectations. The featured speakers will also conduct a practical analysis that compares FDA requirements with those of the PMDA in the context of data standardisation requirements within a submission package to provide attendees with useful insights.
Key topics:
- A practical analysis of the FDA and PMDA Data Standards Catalog and Technical Conformance Guide Details and Interpretation
- An introduction to the FDA guidance documents and technical specifications and how to interpret them
- The importance of the Study Data Standardisation Plan and the Study Data Reviewer's Guide
- Checking for compliance using the FDA Technical Rejection Criteria and the PMDA Study Validation Rules
- Considerations around the FDA Standard Safety Tables and Figures: Integrated Guide and the FDA MedDRA Queries (FMQs)
- Addressing conflicts between the CDISC Foundational Standards and the regulatory documents
- Considerations on developing a concise set of materials useful for both FDA and PMDA submissions
Register for this webinar today to obtain practical guidance for successful global regulatory submissions.
Join experts from ICON Operational Delivery, Kent Letourneau, Executive Director, Global Data Standards; and Sandra Minjoe, Senior Principal, Global Data Standards, for the live webinar on Tuesday, March 26, 2024, at 11am EDT (4pm CET/EU-Central).
For more information, or to register for this event, visit Practical guidance for successful global regulatory submissions: Understanding FDA and PMDA data standards requirements.
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