EXTEDO invites you to its Complimentary Webinar "New FDA Study Validation Criteria - A Practical Guide for Regulatory Professionals".
On October 3, 2016 the FDA published new technical rejection criteria for study data. This new validation criteria will come into effect on December 18.
In this webinar, William Gardner-Mims will discuss the practical implications of the new criteria for Regulatory Operations Professionals including:
- What is required in an eCTD submission under the new guidelines?
- What are the timelines for implementing the new standards for submitting datasets?
- How can Regulatory Operations verify that datasets are "submission-ready" under the new standards?
Following the presentation the speaker will answer your questions in the Q&A session.
Wednesday, 07 December 2016
- 10:00 am EST (New York, Philadelphia)
- 16:00 h CET (Madrid, Berlin)
Duration: 60 minutes