Date and Time
THU, 14 JUN 2018, 10:00 AM - 11:30 AM Central Daylight Time
Description
Join experts from the CDISC ADaM team to learn how to assemble analysis data and related files for submitting NDAs and most BLAs to FDA CDER and CBER. Understand regulatory requirements and learn recommendations for issues that aren't so clear cut. Deliverables discussed include analysis datasets, other files related to analysis datasets, analysis programs, data definition files (define.xml) and the Analysis Data Reviewers Guide (ADRG).
Presenter
- Sandra Minjoe, Senior Principal Clinical Data Standards Consultant, PRA Health Science
- Panelists
- Nate Freimark, Vice President, Clinical Programming and Data Standards, The Griesser Group
- John Troxell, ADaM Implementation Advisor, The Data Standards Consulting Group
Presenters
- Sandra Minjoe
- Nate Freimark
- John Troxell