DIA: Driving Insights to Action
Science:Life Sciences
The South African Health Products Regulatory Authority (SAHPRA) is responsible for regulating health products intended for human and animal use, the conduct of clinical trials, and other duties in South Africa. “Around the COVID-19 pandemic, as regulators, we are having to work very closely with each other because in some jurisdictions clinical trials are ongoing, and we need to access that data. In some jurisdictions, products have been registered and we need to access that data,” explains SAHPRA CEO Dr. Boitumelo Semete-Makokotlela. “It's been humbling to be part of the broader health sector where we contribute to not only saving the lives of South Africans but contribute to the knowledge base across the world and to averting this pandemic.”
Advancing the Science of Study Endpoints
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
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