This year's conference includes presentations from several FDA and PMDA personnel as well as a special Regulatory Panel Discussion:

FDA and PMDA Presentations

  • Huanyu Chen, FDA, Common Data Related Review Issues and Prevention: A Statistical Reviewer’s Thoughts
  • Eileen Navarro Almario, FDA, What Medical Reviewers Can Do with Standardized Data and Metadata Received in Module 5
  • Yuki Ando, PMDA, Topic to be announced

Regulatory Panel Discussion

Many of us submit data and other deliverables to the US FDA and the Japan PMDA. Both of these countries have published regulatory documents, including a technical conformance guide and a data catalog, that tell us what they want to receive. CDISC and CSS industry standards for data and metadata are being accepted by FDA and PMDA. During this panel discussion, panelists from FDA and PMDA will answer questions about how their agencies are using what we send them.

Time: Tuesday, 3:00 PM - 4:00 PM,   Location:Fifth Avenue