DIA: Driving Insights to Action
Science:Life Sciences
In 2017, Health Canada launched the Regulatory Review of Drugs and Devices (R2D2) initiative with the goal of creating a regulatory system that provides greater and faster access to therapeutic products aligned with Canada's healthcare system needs. “One of our greatest achievements was setting up an aligned review process where a manufacturer can make a drug submission to the regulator and make a submission to health technology assessment at about the same time,” explains Megan Bettle, Director General, COVID-19 Regulatory Response Team at Health Canada. “By doing this, we're still making independent decisions but it's allowed those two separate processes to be brought together so you no longer have a prolonged regulatory review, HTA review, you have decisions being made much closer in time. It's making it more efficient for drugs to actually get to patients who need them.”
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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