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Drug Development Tools in a Digital Era
Session Chair(s)
Lauren Oliva, PHARMD, RPH
US Regulatory Policy Lead, Biogen, United States
Explore opportunities and challenges ahead for digital drug development tools (DDTs) from an EMA, consortium, and industry perspective. Analyze how existing regulatory frameworks apply to the emerging field of digital health technologies including case examples, and discuss issues to be addressed to promote advancement of digital DDTs.
Learning Objective : Describe the EMA, industry, and consortium views on digital drug development tools (DDTs); Discuss the growing value of digital health tools as part of the drug development process including key learnings from sponsor experience; Evaluate case example(s) in the development of digital DDTs.
Speaker(s)
Critical Path Update
Senior Advisor, Critical Path Institute, United States
EMA Update
Scientific Officer, PRIME Coordinator, Scientific and Regulatory Management Dept, European Medicines Agency, Netherlands
Industry Update
Director, Digital Science, Abbvie, United States
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