DIA: Driving Insights to Action
Science:Life Sciences
What is regulatory science? Who does it impact and how? In this exclusive Global Forum podcast, Dr. David Strauss, Director of the Division of Applied Regulatory Science in the FDA Office of Clinical Pharmacology, discusses intersecting advancements in regulatory, basic, and clinical science, including the model-informed drug development provisions of PDUFA VI. “The Division of Applied Regulatory Science was created to move new science into the CDER review process and close the gap between scientific innovation and drug review,” explains Dr. Strauss. “We perform mission-critical applied research and review across the translational research spectrum that includes in vitro and in vivo laboratory research, in silico computational modeling and informatics, and integrated clinical research covering clinical pharmacology, experimental medicine, and postmarket analyses. We try to focus on things where FDA can really provide unique value.” Bonus Reading: Translating New Science Into the Drug Review Process: The US FDA's Division of Applied Regulatory Science.
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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