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DOWNLOADABLE PRESENTATIONS
25 OCT, 2018 | 1st DAY: PK COURSES
MORNING COURSE SESSION:
Uni- and multivariate Bioequivalence of PK parameters
Lecturers of the Morning Course Session: ![]() Professor of Statistics, Medical and Pharmaceutical Statistics Research Unit, Department of Mathematics and Statistics, Lancaster University, UK |
![]() Deputy Director Research Design and Conduct Service and Research Fellow, Cardiff University, UK |
This presentation material is available only for those visitors who attended at the 1st-day course programme of the 3rd Biosimilars Forum.
AFTERNOON COURSE SESSION:
Statistical aspects of equivalence testing for biosimilar studies: multiple, differently-scaled endpoints
![]() Ludwig A. HOTHORN, Professor of Biostatistics at Leibniz Universität Hannover, Faculty of Natural Sciences, Germany |
This presentation material is available only for those visitors who attended at the 1st-day course programme of the 3rd Biosimilars Forum.
26 OCT, 2018 | 2nd DAY SYMPOSIUM AND ROUND TABLE: Clinical Research and Regulatory
An update on development strategies of recently approved biosimilars in Europe
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Presentation material
(.PDF, 674 KB)
Scientific Keynote Presentation:
Bioequivalence of highly variable drug products – an update
![]() Professor Emeritus of Pharmacology and Biostatistics, University of Toronto; Former President of Canadian Society for Pharmaceutical Scientists |
![]() Associate Professor, Faculty of Pharmacology, Semmelweis Medical University |
Presentation material
(.PDF, 1 410 KB)
Challenging issues in extrapolation of totality of evidence to pediatric indications in case of biosimilars
![]() 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 |
Presentation material
(.PDF, 1015 KB)
Regulatory Keynote Presentation:
The biosimilar concept revisited – is there a need for change?
![]() Unit Head, Austrian Medicines and Medical Devices Agency |
Presentation material
(.PDF, 1 432 KB)
Opportunities and limitations of a blinded sample size reassessment in biosimilars development
![]() Head of Biostatistics and Data Management, Fresenius-Kabi |
Presentation material
(.PDF, 584 KB)
Incorporating historical information in biosimilar trials: Challenges and a hybrid Bayesian‐frequentist approach
![]() Early Stage Research Fellow, IDEAS Innovative Training Network |
Presentation material
(.PDF, 1 099 KB)
How the increase of assay sensitivity influences the immunogenicity
![]() Director Biostatistics for Biostatistics Biosimilars, Analytics group, Novartis, Germany |
Presentation material
(.PDF,814 KB)
Animal models of immunogenicity and immune toxico-equivalence testing of nano-biopharmaceuticals
![]() 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, 4 080 KB)
27 OCT, 2018 | 3rd DAY SEMINAR in Nanomedicines
MORNING SEMINAR SESSION:
The Era of Biosimilars and Nanosimilars: Current Perspectives
![]() President of Bawa Biotech LLC; Scientific Advisor at Teva Pharmaceutical Industries, Israel; Founding Director of American Society for Nanomedicine; Editor-in-Chief of the Handbook of Clinical Nanomedicine: Nanoparticles, Imaging, Therapy, and Clinical Applications, (CRC Press, 2016); USA |
- Presentation material (.PDF, 30 674 KB)
- CBS News Video: What is Nanotechnology? (Online Video File)
- Book overview: Current Immune Aspects of Biologics and Nanodrugs (.PDF, 3 878 KB)
- Book chapter: Raj BAWA: Current Immune Aspects of Biologics and Nanodrugs: An Overview (.PDF, 7 743 KB)
- Resource Center: Discover more relevant information and dowloadable materials here!
The immunological characterization of nanotechnology-formulated drugs
![]() Senior Principal Scientist and Head of the Immunology Section at the Nanotechnology Characterization Laboratory, USA |
Presentation material
(.PDF, 5 746 KB)
Targeted Nanomedicine: State of Art and Future Developments
![]() Professor of Targeted Nanomedicine at the University of Utrecht; Professor of Targeted Therapeutics at the MIRA Institute of the University of Twente; The Netherlands |