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?”
Relevance Will Put Europe on Investment Fast Track
Risk Inherent in Benefits of Drug/Device Products?
EU Business and Data Needs Converge Through Telematics
RIM Accelerating Efficiencies in Regulatory Pathways
Translating Clinical Trials into Clinical Benefit
More Tools & Data Sources: More Insights for RBM?
Landmark AMA to Rely on Regulatory Reliance
Healthy Population Key to Economic Success
Defining Rational Medicine and Research at DIA Japan 2019
How Do You Put Your Disease on the Agenda?
Participatory Medicine Changing Information Exchange
New Ethics and Consent Guidelines Pillars for Safety in India
Real World Data Expanding into Label Expansion
Educating Persons Critical in Personalized Medicine
FDA Payer Communication Guidance Steps Toward Sustainability
Genetic Engineering Transforming Research Ethics
Only Big Trust Propels Big Data into Big Discoveries
Empowering Today’s Patients to Help Tomorrow’s
Imaging Data Plus AI “One of the Best Combinations”
Clinical Trial Diversity Begins (and Ends) with Patients First
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