DIA: Driving Insights to Action
Science:Life Sciences
For regulators in Brazil, the pandemic’s aftermath includes a backlog of post-approval changes, delayed by emergency development of COVID-19 vaccines and therapies, related to biologic product quality. ANVISA’s new Online Optimized Assessment Project has significantly resolved these pending requests. “The pandemic had already enabled use of online tools for remote assessment of applications and virtual meetings between ANVISA and applicants, and also helped us be closer to other reference regulatory authorities in the process of building trust,” explains project architect Elkiane Macedo Rama, an Adviser of ANVISA’s Third Directorate. “The Online Optimized Assessment Project was a way to gather all these tools in a strategy to speed up the review process of these applications.”
Complexity Continues to Challenge Clinical Costs
Maximizing Regulatory Resources Across Latin America
Data Intersections Connecting Drug Development with Clinical Care
Sharing Cloud-Based Data as They Emerge: Accumulus Synergy Part 2
Sharing Cloud-Based Data as They Emerge: Accumulus Synergy Part 1
Advanced Tests and Therapies Making Daily Care Anything But Routine
Innovation Without Access Will Never Meet Patient Needs
Three Good Reasons to Use Artificial Intelligence in Pharmacovigilance
EU Regulatory Strategies Shaping and Shaped by Pandemic Response
Telehealth Emerging in Japan’s Clinical Research and Care
Aligned Review Timelines Key to Co-Developing Companion Diagnostics
Early Access Programs Complicating Comparative Data Analyses
New PAHO Report: Strength in Regulatory Reference and Reliance
eLabeling More than Moving from Paper to Digital
RIM Whitepaper V2 and RIM Reference Model: Advancing Regulatory Science
Australia: Growing Clinical Trials Even in Pandemic’s Wake
Remote Tools Keep Japan's Research Moving
DIA Promoting Community, Pushing Back Misinformation
Japan Healthcare 2035: Focus on Basic Science & Economics
DARWIN EU: Evolution in Europe’s Use of Big Data
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