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Expect the Unexpected: Challenges and Opportunities in the Clinical Development of Biopharmaceuticals
Session Chair(s)
Diane Seimetz, PharmD
Co-founder, Biopharma Excellence, Germany
Expect the Unexpected: Challenges and Opportunities in the Clinical Development of Biopharmaceuticals
Speaker(s)
Industry Perspective on Today’s Challenges and Opportunities in the Clinical Development of Biopharmaceuticals
Nikolai Constantin Brun, MD
Co-Chair, EMA-MHA Big Data Task Force; Dir, Div for Medical Eval & Biostatistics, Danish Medicines Agency, Denmark
Challenges, Opportunities and Mitigation Strategies for Biopharmaceutical Development: Learn from Case Studies across Different Stages of Development
Diane Seimetz, PharmD
Co-founder, Biopharma Excellence, Germany
Agency Perspective on the Future Paradigm of an Integrated Clinical Development for Biopharmaceuticals: What Will Be Expected for Approval and Beyond?
Jan Mueller-Berghaus, MD
Clinical Assessor, Paul-Ehrlich-Institut, Germany
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