21 Aug 2014
11:00-12:30 PM ET
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Agenda:
- CFAST Update
- Draft Analysis Results Metadata for Define-XML 2.0
- Good Practice in PMA Submissions for Efficient Regulatory Decision Making
Abstract:
In this talk I (Rajesh Nair, FDA) will discuss some of the highlights of the Medical Device User Fee amendment of 2012 (MDUFAIII) and the impact of MDUFA III goals on the review clock. The talk will provide a statistical reviewers perspective on how sponsor’s can help improve the efficiency of the FDA review process by submitting comprehensive “ready-to-review” submissions. Among the major issues faced by reviewers is that most of the study data submitted in PMA submissions is in non standard data formats and often not analysis ready.
Speakers:
- Rhonda Facile, CDISC
- Monika Kawohl, Accovion GmbH
- Lex Jansen, SAS
- Rajesh Nair, FDA
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