DIA: Driving Insights to Action
Science:Life Sciences
“The ground is shifting in terms of how we will continue using randomized clinical trial data and real-world data in many different disease settings,” says Veronica Miller, co-author of Use of External Controls in FDA Regulatory Decision Making. In this research article, Miller (Forum for Collaborative Research) and Adora Ndu (Bridgebio Pharma, Inc.) describe where and how FDA has used external controls to support development and approval of drugs for rare and pediatric diseases. “We're seeing, not just in rare diseases but in many other diseases, this coming together of what used to be totally separate silos. In part, that's facilitated through electronic health records and other mechanisms of capturing data and being able to follow data at a bigger level, but also just because of understanding the importance of clinical data.”
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
DIAmond Session 203: “Innovation is Clearly Happening”: Next Generation Collaboration: Transforming the Industry
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