DIA: Driving Insights to Action
Science:Life Sciences
As drug development and market approval grow more connected and complex, effective regulatory information management (RIM) is more essential than ever. “The ideal state would be to leverage regulatory data as a corporate asset,” suggests Venkatraman “Bala” Balasubramanian, Senior Vice President of Life Sciences, Orion Business Innovation. “Regulatory teams will be able to better advise portfolio teams on probability of regulatory success in any given market, so you’re going to have higher success rates from a regulatory perspective going forward,” concurs Pat Shafer, Managing Director, FTI Consulting. Bala and Pat serve in the Working Group developing the Regulatory Information Management reference model discussed at DIA's 2020 Regulatory Submissions Information & Document Management Forum.
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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