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?”
Future Science & Drug Review: FDA Closing the Gap
HHS Final Rule: Good Data Shared Well Leads to Great Science
Patient Partners: Power That Rests in Us All
Technology & Data Driving Europe’s ClinOps Forward
CFDA Joins ICH, Seeks Public Comment on Further Reforms
New DIA Forum to Align Regulatory & ClinOps Expectations
Different Roots, Shared Fruits: FDA-EMA Collaboration
RWE: Bridge Between Clinical Research & Practice?
Progress in Pediatric Therapeutics Bigger Than “Smaller Dose”
Is Drug Repurposing Really As Promising As It Seems?
More Than Socially Fair or Economically Just – It’s Better Science
New China-Denmark Food & Drug Regulatory Cooperation Centre
ABPI Sees Brexit as One Game of Two Halves
Europe’s IMI Helps Drive New R&D and Access Models
Lack of Access Can Lock Patients in “Disease of Despair”
Can We “Pay for Results” to Sustain Innovation?
Uncertainty is Certain: Pandemic Vaccine Preparedness
Where and How to Bridge the EU Biotech Funding Gap
Transparency Essential to Payers’ New Role in EU
EBE Plots Path from “Flawed Underfunded Biotech System”
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