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Veranstaltungsort: Bethesda, USA

SYMPOSIUM 7: Establishing Biosimilarity: The European Perception, Experience & Future Trends

The European Federation for Early Medicines Development (EUFEMED) organises the symposium at the ACCP Annual Meeting 2016.

Co-chairs: Hildegard Sourgens, MD, PhD, President Elect, European Federation for Exploratory Medicines Development and Hartmut Derendorf, PhD, Distinguished Professor & Chair, V. Ravi Chandran Professor in Pharmaceutical Sciences, University of Florida

Target audience: The target audience includes healthcare professionals who are involved in the research and development of biopharmaceuticals/biosimilars, regulatory affairs (competent authorities; pharmaceutical industry), pharmacovigilance and/or biotech start-ups.

Goals and Objectives: The goal is for participants to learn from the European Medicines Agency’s (EMA) 15-year experience in biosimilars and assess if similar concepts can be adopted in the US.

Following completion of this activity, the learner will be able to:

  • Demonstrate the primary contribution of analytical comparability and its meaning for clinical development;
  • Analyze the European experience with respect to clinical and nonclinical development programs, approval success, post-marketing performance and the failures of European biosimilar programs (as far as these can be made public);
  • Develop the impact of pharmacokinetics/pharmacodynamics to detect differences between a reference medicinal product and a biosimilar;
  • Demonstrate the safety of biologicals and biosimilars based on the European experience;
  • Demonstrate the discriminative power of analytics and pharmacokinetic and/or pharmacodynamic profiles vs Phase 3 trials.

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