Scientific factors in biosimilar product development
 László ENDRÉNYI,Professor Emeritus of Pharmacology and Biostatistics, University of Toronto; Former President of Canadian Society for Pharmaceutical Scientists |
DOWNLOADABLE PRESENTATIONS
5 OCT, 2017 | 1st DAY COURSES
Presentation material
(.PDF, 1319 KB)
Open issues in the assessment of bioequivalence and biosimilarity
 The course is lectured by:Helmut Schütz, Owner at BEBAC – Consultancy Services for Bioequivalence and Bioavailability Studies |
- Part 01: Carry-over (.PDF, 333 KB)
- Part 02: Group effect (.PDF, 450 KB)
- Part 03: GSD and TSD (.PDF, 1082 KB)
- Part 04: Reference-scaling (.PDF, 1222 KB)
Benefit from our expertise in biosimilars
Accelsiors’ biosimilar team is ready to accelerate your development program! Combining our proficiency in different therapeutic areas, with well-tailored service capabilities and access to diverse patient populations, Accelsiors will support every aspect of clinical and nonclinical development of your biosimilar or biobetter compound – from the concept through pre-clinical development to successful conduct of Phase III registration trial.
Some of 
‘ values provided for your success:
2 decades of experiences in biosimilar clinical trials
World-class
biosimilar knowledge base
Dedicated team of biosimilar
experts
Time- and cost efficient solutions to accelerate your program
Global resources
with a flexible local support
Complete range
of expertise tailored for your specific needs
DO YOU NEED MORE PROFESSIONAL HELP?
Feel free to ask ‘ Biosimilar Reserach experts!
Work together with the pioneers in biosimilars
Accelsiors is a scientific-driven, global, full-service CRO with extensive professional background in biosimilars development. Our professionals were among the first pioneers in the biosimilars field since we have been supporting biosimilar development programs form 1996 with the first biosimilar, somatotropin.
Let us to accelerate your biosimilar program by sharing with you our expertise and well-tailored service capabilities!
6 OCT, 2017 | 2nd DAY SYMPOSIUM
Clinical trials for biosimilars in Europe: an updated systematic comparison of the clinical development programs
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Johanna MIELKE,
Presentation material
(.PDF, 637 KB)
Algorithms for evaluating reference scaled average bioequivalence: power, bias and consumer risk
 László TÓTHFALUSI,Associate Professor, Faculty of Pharmacology, Semmelweis Medical University, Budapest |
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Co-author: László ENDRÉNYI, Professor Emeritus of Pharmacology and Biostatistics, University of Toronto; Former President of Canadian Society for Pharmaceutical Scientists |
Presentation material
(.PDF, 1748 KB)
1st Keynote lecture: 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 |
Presentation material
(.PDF, 1019 KB)
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 |
Presentation material
(.PDF, 783 KB)
2nd Keynote lecture: 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, Budapest, Professor at University of Miskolc, Dep. of Nanobiotechnology and the Regenerative Medicine, Institute of Theoretical Medicine |
Presentation material
(.PDF, 6 439KB)
Round table discussion:
 Regulatory perspective: Stephan LEHR,Biostatistician, Austrian Medicines and Medical Devices Agency, President, Viennese Section of IBS |
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Industry perspective: Heike WÖHLING, Head of Biostatistics, Sandoz Biopharmaceuticals |
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- Stephan LEHR / Round Table slides (.PDF, 1 342 KB)
- Heike WÖHLING, / Round Table slides (.PDF, 745 KB)
Leaflet of the 2nd Annual Biosimilrs Forum with Agenda
Leaflet of the Forum
(.PDF, 1.15 MB)
Copyrights notice
© Copyrights: All of these presentation materilas and the content of these are owned by the authors of the lectures and are protected by copyright laws and international treaty provisions. Reproduction of any material on these lectures is only authorized for exclusive information for strictly personal and private use. Any reproduction and/or representation of all or part of the lectures, or any of the elements that compose it, on any media whatsoever, for any other purpose, including commercial, is expressly prohibited, unless the prior written authorization from the authors.
