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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
Danish Medicines Agency, Denmark
Co-Chair, EMA-MHA Big Data Task Force; Dir, Div for Medical Eval & Biostatistics
Challenges, Opportunities and Mitigation Strategies for Biopharmaceutical Development: Learn from Case Studies across Different Stages of Development
Diane Seimetz, PharmD
Biopharma Excellence, Germany
Co-founder
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
Paul-Ehrlich-Institut, Germany
Clinical Assessor
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