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.”
Analyzing Innovation’s Progress in Gottlieb Era
Comparing Generic Safety Profile with Branded Cousin
Defining Unmet Need Critical to Determining Value
Triple-A RWE: Adequate Data, Appropriate Designs, Actionable Evidence
US REMS Requirements for NDAs and BLAs
Epoietin Biosimilars: Qualitative Study of Patients' Views
Disparities Between FDA/EMA Review Processes
DIA Japan's Focus in Fall 2018
FDA Leadership on Future Biologics and EMA/FDA Cooperation
Global Perspectives on Patient Engagement
DIA Board Chair Discusses DIA Now and Digital Tomorrow
Integrating Genetic Medicine into Clinical Care
Regulatory Landscape of Drug-Device Combination Products
Value-Based Assessment & Contracting: What Needs to Be Done?
Block Chain, AI, Internet of Things: Future of PharmaTech?
“My Voice Needed to Be Heard”
IMEDS Collaboration Builds Upon Sentinel Surveillance
Crafting Sound Medical Affairs Professionals
Statistical Strategies for Using Sources of Safety Data
Regulatory & Ethical Considerations in a Pediatric Trial
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