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?”
RCT & RWE: Evolution, Revolution or Integration?
New MD and IVD Regulations: Implications of Implementation
DIA EMEA: Research in Europe “Disconnected from Business”
Blockchain, AI and Other Radical Drivers of Biopharmaceutical Innovation
FDA Overviews New EU-US MRA on GMP
Networking 101: Extrovert or Introvert? In Person or Online?
DIA Forum Acts on Statistical Impact of 21st Century Cures
Q12 Aims to Align CMC with Accelerated Development & Approval
EuroMeeting Preview: Real-World Data + AI = Clinical Evidence?
Cures Within Reach at DIA 2017: Good Therapies at Reasonable Cost
EuroMeeting Co-Chair Envisions “Continuous Loop” from Bench to Bedside and Back
BfArM President: Real-World Data & Randomized Trials “Compatible, Complementary Tools”
PatientsLikeMe: Patient Value Should Drive Market Value
Value & Access Experts Explain Price for Progress at EuroMeeting 2017
MHRA Chief Executive: Today’s Learning Will Inform Next Gen Products
Can Our Future Afford Today’s Model of Innovation?
Chair of DIA Council of Regulators Previews Risk Management & Drug Safety Updates
Bringing Regulators & the Regulated Together: DIAmond Session 412: CDER Town Hall
DIAmond Session 303: Value-Based Health Care Decision Making: The Quest for Smarter Spending
DIAmond Session 302: Europe and the US: Making Outcomes-Based Health Care Possible
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