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X-WR-CALDESC:Events for AGAH
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DTSTART:20160327T010000
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DTSTART:20161030T010000
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DTSTART;VALUE=DATE:20160926
DTEND;VALUE=DATE:20160927
DTSTAMP:20260929T022357
CREATED:20190604T204620Z
LAST-MODIFIED:20190617T071046Z
UID:3108-1474848000-1474934399@dev.agah.eu
SUMMARY:SYMPOSIUM 7: Establishing Biosimilarity: The European Perception\, Experience & Future Trends
DESCRIPTION:The European Federation for Early Medicines Development (EUFEMED) organises the symposium at the ACCP Annual Meeting 2016. \nCo-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 \nTarget 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. \nGoals 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. \n\n\n\n	Content \n\nDemonstrate the primary contribution of analytical comparability and its meaning for clinical development\nAnalyze 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)\nDevelop the impact of pharmacokinetics/pharmacodynamics to detect differences between a reference medicinal product and a biosimilar\nDemonstrate the safety of biologicals and biosimilars based on the European experience\nDemonstrate the discriminative power of analytics and pharmacokinetic and/or pharmacodynamic profiles vs Phase 3 trials\n\nPlease find further details on: \nhttps://accp1.org
URL:https://dev.agah.eu/event/symposium-7-establishing-biosimilarity-the-european-perception-experience-future-trends-2/
LOCATION:AGAH Workshop\, Bethesda\, Vereinigte Staaten
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