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The State of Informatics at CDER and CBER
Session Chair(s)
Steve Wilson, PhD
Senior Staff Fellow, OB, OTS, CDER, FDA, United States
CDER and CBER are working towards all electronic environments in order to streamline and facilitate the review of electronic submissions. This forum focuses on the Centers' goals, experiences and practical advice for sponsors and consultants.
Learning Objective : Explain CDER's and CBER's current initiatives and future vision with respect to electronic submissions and implementation of standards; Identify technical challenges associated with maintaining regulatory compliance from FDA's perspective; Discuss that submissions under Investigational New Drugs (IND), New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), and Biologic License Applications (BLA) must be in electronic format as specified in the guidance.
Speaker(s)
CDER Perspective
Hilmar Hamann, PhD
Chief Information Officer, European Medicines Agency, Netherlands
CBER Perspective
Vada Perkins, MS
Vice President, Global Head of Regulatory Intelligence & Policy, Boehringer Ingelheim, United States
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