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5 OCT, 2017 | 1st DAY COURSES
COURSE 1: Scientific factors in biosimilar product development
Course | 
1:04:35
László ENDRÉNYI
Professor Emeritus of Pharmacology and Biostatistics, University of Toronto;
Former President of Canadian Society for Pharmaceutical Scientists
Professor Emeritus of Pharmacology and Biostatistics, University of Toronto;
Former President of Canadian Society for Pharmaceutical Scientists
COURSE 2: Open issues in the assessment of bioequivalence and biosimilarity
1st Part of the course | 53:37
Carry-over
2nd Part of the course | 52:05
Group effect
3rd Part of the course | 1:39:40
GSD and TSD | Reference-scaling
Helmut Schütz
Owner at BEBAC – Consultancy Services for Bioequivalence and Bioavailability Studies
Owner at BEBAC – Consultancy Services for Bioequivalence and Bioavailability Studies
6 OCT, 2017 | 2nd DAY SYMPOSIUM AND ROUND TABLE: Clinical Research and Regulatory
Case Study | 33:25
Clinical trials for biosimilars in Europe: an updated systematic comparison of the clinical development programs
Johanna MIELKE
Biostatistician,
Novartis Pharma AG
Biostatistician,
Novartis Pharma AG
Case Study | 32:45
Algorithms for evaluating reference scaled average bioequivalence: power, bias and consumer risk
László TÓTHFALUSI
Associate Professor, Semmelweis University;
Associate Professor, Semmelweis University;
Co-author: László ENDRÉNYI, Professor Emeritus of Pharmacology and Biostatistics, University of Toronto
Regulatory Keynote Presentation | 57:37
12 years of biosimilars in Europe: what’s the exposure and response in our learning curve?
Andrea LASLOP
Unit Head, Austrian Medicines and Medical Devices Agency;
Member of the Scientific Advice Working Party of the EMA; Austrian delegate in the Committee for Human Medicinal Products of the EMA
Unit Head, Austrian Medicines and Medical Devices Agency;
Member of the Scientific Advice Working Party of the EMA; Austrian delegate in the Committee for Human Medicinal Products of the EMA
Case Study | 26:30
Regulatory perspective on comparison of quality attributes in drug development
Ina-Christine RONDAK
Biostatistician,
Seconded National Expert from Klinikum rechts der Isar of Technische Universität München to EMA
Biostatistician,
Seconded National Expert from Klinikum rechts der Isar of Technische Universität München to EMA
Keynote Presentation | 51:02
Immune side effects of biologicals and nanomedicines: unsolved issues in bio- and nanosimilar development
János SZEBENI
Director of the Nanomedicine Research and Education Center, Semmelweis Medical University
Director of the Nanomedicine Research and Education Center, Semmelweis Medical University
Discussion | 1:54:18
Round Table Session
Modarator: Stephan LEHR
Biostatistician, Austrian Medicines and Medical Devices Agency;
President, Viennese Section of IBS
Biostatistician, Austrian Medicines and Medical Devices Agency;
President, Viennese Section of IBS
