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).
Members Only Mini-Trainings are a benefit of CDISC membership. All employees of CDISC members may participate in Members Only Mini-Trainings. If your organization is not a CDISC Member, join us to support the development and adoption of global standards and reap the many benefits of CDISC membership. Should you have membership-related questions, please contact membership@cdisc.org.
Note: Please use your corporate e-mail address to register for this webinar. This is to confirm your CDISC membership.Confirmations will be sent out within a few days after your completed registration.
Webinar Language
English
Presenter
- Sandra Minjoe, Senior Principal Clinical Data Standards Consultant, PRA Health Sciences
Panelists
- Nate Freimark, Vice President, Clinical Programming and Data Standards, The Griesser Group
- John Troxell, ADaM Implementation Advisor, The Data Standards Consulting Group
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