DIA: Driving Insights to Action
Science:Life Sciences
Harmonizing clinical trial assessment and supervision in the EU through the portal and database established by the new EU Clinical Trial Regulation, and maintained by the EMA, is not the only change rippling through clinical trials in Europe, explain Dr. Mireille Muller, Regulatory Policy Director for Novartis A-G in Switzerland; and Dr. Greet Musch, Director-General for Pre-Authorisation at the Federal Agency for Medicines and Healthcare Products of Belgium. Dr. Muller and Dr. Musch will help lead discussions on this topic at DIA Europe 2018.
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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