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.
RCT & RWE: Evolution, Revolution or Integration?
New MD and IVD Regulations: Implications of Implementation
DIA EMEA: Research in Europe “Disconnected from Business”
Blockchain, AI and Other Radical Drivers of Biopharmaceutical Innovation
FDA Overviews New EU-US MRA on GMP
Networking 101: Extrovert or Introvert? In Person or Online?
DIA Forum Acts on Statistical Impact of 21st Century Cures
Q12 Aims to Align CMC with Accelerated Development & Approval
EuroMeeting Preview: Real-World Data + AI = Clinical Evidence?
Cures Within Reach at DIA 2017: Good Therapies at Reasonable Cost
EuroMeeting Co-Chair Envisions “Continuous Loop” from Bench to Bedside and Back
BfArM President: Real-World Data & Randomized Trials “Compatible, Complementary Tools”
PatientsLikeMe: Patient Value Should Drive Market Value
Value & Access Experts Explain Price for Progress at EuroMeeting 2017
MHRA Chief Executive: Today’s Learning Will Inform Next Gen Products
Can Our Future Afford Today’s Model of Innovation?
Chair of DIA Council of Regulators Previews Risk Management & Drug Safety Updates
Bringing Regulators & the Regulated Together: DIAmond Session 412: CDER Town Hall
DIAmond Session 303: Value-Based Health Care Decision Making: The Quest for Smarter Spending
DIAmond Session 302: Europe and the US: Making Outcomes-Based Health Care Possible
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