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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
Stephen Joel Coons, PHD
Critical Path Institute, United States
Senior Advisor
EMA Update
Zahra Hanaizi, PHARMD, MPHARM
European Medicines Agency, Netherlands
Scientific Officer, PRIME Coordinator, Scientific and Regulatory Management Dept
Industry Update
Josh Cosman, PHD
Abbvie, United States
Director, Digital Science
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