DIA: Driving Insights to Action
Science:Life Sciences
In 2002, the FDA established the Office of Combination Products (OCP) to help manage complicated jurisdictional issues in the regulatory review and approval of drug delivery devices and diagnostics growing in both number and complexity. “I can only imagine what the possibilities will be with respect to the use of things like artificial intelligence and smart devices as they pertain to the delivery of medical products going forward. I feel it’s going to go far beyond where we could have ever foreseen,” suggests Kim Quaintance-Lunn, Vice President and Head of US Regulatory Policy for Bayer, and a member of the program committee for DIA's Combination Products 2017 Conference, in this Global Forum podcast. “The challenge that comes with that is, of course, from a regulatory perspective, how do you regulate that? How do you get in front of an area that moves so quickly as to be hard to even predict?”
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Complexity Continues to Challenge Clinical Costs
Maximizing Regulatory Resources Across Latin America
Data Intersections Connecting Drug Development with Clinical Care
Sharing Cloud-Based Data as They Emerge: Accumulus Synergy Part 2
Sharing Cloud-Based Data as They Emerge: Accumulus Synergy Part 1
Advanced Tests and Therapies Making Daily Care Anything But Routine
Innovation Without Access Will Never Meet Patient Needs
Three Good Reasons to Use Artificial Intelligence in Pharmacovigilance
EU Regulatory Strategies Shaping and Shaped by Pandemic Response
Telehealth Emerging in Japan’s Clinical Research and Care
Aligned Review Timelines Key to Co-Developing Companion Diagnostics
Early Access Programs Complicating Comparative Data Analyses
New PAHO Report: Strength in Regulatory Reference and Reliance
eLabeling More than Moving from Paper to Digital
RIM Whitepaper V2 and RIM Reference Model: Advancing Regulatory Science
Australia: Growing Clinical Trials Even in Pandemic’s Wake
Remote Tools Keep Japan's Research Moving
DIA Promoting Community, Pushing Back Misinformation
Japan Healthcare 2035: Focus on Basic Science & Economics
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