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Session Chair(s)
Steve Wilson, PHD
Senior Staff Fellow, OB, OTS, CDER
FDA, United States
Learning Objective : Discuss issues related to the filing review of standardized analysis study data to ensure acceptance by FDA reviewers; Describe challenges and the progress made in establishing Analysis Data Model (ADaM) data standards for therapeutic areas; Identify and discuss opportunities to increase efficiencies of employing ADaM standards in creating analysis files for submission; Explain and discuss the EMA’s motivation and plans for “raw data” submission, and review and secondary use of analysis data.
Speaker(s)
Clinical Trial Data: Open For All? Recent Developments at EMA
Frank Petavy, MS
European Medicines Agency, Netherlands
Head of Methodology
ISAP and ADaM Datasets: Keys to Developing Integrated Safety Analyses
James Zuazo, MSC
MMS Holdings Inc., United States
Senior Biostatistician
ADaM Double-Header: ADaM Therapeutic Area Standards and Considerations for Ensuring the Successful Submission and Review of ADaM Data
Dana J. Soloff, MS
Genzyme Corporation, A Sanofi Company, United States
Senior Director, Standards and Architecture
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