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Session Chair(s)
Diane Seimetz, PHARMD
Co-founder
Biopharma Excellence, Germany
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