DIA: Driving Insights to Action
Science:Life Sciences
In April 2023, Professor John Skerritt retired after 11 years of exemplary public service as deputy secretary of the Health Products Regulation Group and head of the Therapeutic Goods Administration in Australia. “What's really changed and what will persist after COVID? First, I think regulators have become a bit more comfortable in dealing with uncertainty. Uncertainty is the biggest challenge rather than benefit-risk,” he explains. “International regulatory collaboration became the basis of working together on these new products: We exchanged information on policies, on how the clinical data was developing, on the real-world performance of these drugs and vaccines, and on safety and post-approval requirements. These are going to persist.”
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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”
RCT & RWE: Evolution, Revolution or Integration?
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