Overview:
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. We 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. We also conduct a practical analysis, comparing 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
Audience:
- Quality Assurance
- Project Management
- Regulatory Affairs
- Biostatistics
- Statistical Programming
- Data Management
- Data Standards
- Medical Writing
Presenters:
Kent Letourneau
In 2015, Kent was appointed Head of ICON’s Global Data Standards team, overseeing the development, implementation, and governance of end-to-end standards, from data collection through analysis and reporting.
Sandra Minjoe
Sandra joined ICON in February 2018. She has been in the biotech/pharma industry since 1993, with roles in standards, programming, statistics, data management, and project management. Her education includes a BS in Mathematics and an MS in Statistics. She has prior experience at both sponsors (Genentech, Gilead, Xoma, Otsuka) and vendors (Accenture, Octagon).
Since joining the CDISC ADaM team in 2001, Sandra has contributed to many of the ADaM public documents and led several ADaM projects. She is a former ADaM Team Lead, represented ADaM in higher-level CDISC decisions, is a certified CDISC ADaM trainer, and regularly presents on ADaM topics at industry meetings.