DIA: Driving Insights to Action
Science:Life Sciences
Growing globalization of supply chains, patient recruitment and clinical trials has made cooperation among the world’s regulatory agencies more important than ever. In this exclusive Global Forum podcast, Dr. Sandra Kweder, Deputy Director in the FDA Office of International Programs’ Europe Office, and FDA’s Liaison to the European Medicines Agency, discusses regulatory collaboration in the modern health care product ecosystem. “My role specifically is to bring our two agencies together. That’s my job,” she explains. “My job operates at many levels. One is to provide someone onsite at EMA to help EMA understand FDA. We do the same things but our systems could not be more different. At the same time, my job is to observe EMA and try to translate EMA back to my FDA colleagues. Simply because we have arisen from different roots, we often approach the same thing from different angles.” Dr. Kweder will be featured speaker in several DIA 2017 Global Annual Meeting sessions.
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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