This 2-day series of events consisted of a professional COURSE DAY and a SYMPOSIUM DAY, comprising burning issues in Biosimilar development with a dedicated focus on the statistical and regulatory aspects of follow-on biologics.
During these two interactive days the forum ensured maximum knowledge transfer among professionals, regulators and leading subject matter experts in biosimilar development to exchange and elaborate on the best practices and debate the evolving landscape, pitfalls and current perspectives of biosimilars.
SYMPOSIUM DAY PROGRAMME 18 OCT
Federal Institute for Drugs and Medical Devices (BfArM), Germany
Biostatistician, Seconded National Expert from Klinikum rechts der Isar of Technische Universität München to EMA, Germany
Hungarian member of EMA Committee for Human Medicinal Products (CHMP), and EMA Paediatric Committee (PDCO); Unit Head at National Institute of Pharmacy and Nutrition, Hungary
Regulatory perspective: Andrea LASLOP
Head of Scientific Office, Austrian Medicines and Medical Devices Agency (AGES), Austria;
Member of the Scientific Advice Working Party (SAWP) of the European Medicines Agency; Austrian delegate in the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency
Chief Scientific Officer, Accelsiors CRO Ltd.;
President of the Hungarian Society for Clinical Biostatistics, Hungary
Biostatistician, Austrian Medicines and Medical Devices Agency (AGES);
Assessor, EMA Biostatistics Working Party; Alternate Member, EMA Scientific Advice Working Party;
Former President of the Viennese Section of the International Biometric Society, Austria