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DOWNLOADABLE PRESENTATIONS
25 OCT, 2018 | 1st DAY: PK COURSES
MORNING COURSE SESSION:
Uni- and multivariate Bioequivalence of PK parameters
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Lecturers of the Morning Course Session:  Thomas JAKIProfessor of Statistics, Medical and Pharmaceutical Statistics Research Unit, Department of Mathematics and Statistics, Lancaster University, UK |
 Philip PALLMANN Deputy Director Research Design and Conduct Service and Research Fellow, Cardiff University, UK |
- Part 01: T. Jaki: Non-compartmental estimation of PK parameters (.PDF, 1 MB)
- Part 02: P. Pallmann: Univariate Bioequivalence (.PDF, 582 KB)
- Part 03: P. Pallmann: Multivariate Bioequivalence (.PDF, 16 MB)
- Part 04: T. Jaki: Multiplicity and Bioequivalence (.PDF, 556 KB)
AFTERNOON COURSE SESSION:
Statistical aspects of equivalence testing for biosimilar studies: multiple, differently-scaled endpoints
 The course is lectured by:Ludwig A. HOTHORN, Professor of Biostatistics at Leibniz Universität Hannover, Faculty of Natural Sciences, Germany |
Presentation material
(.PDF, 1 637 KB)
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
 László ENDRÉNYI,Professor Emeritus of Pharmacology and Biostatistics, University of Toronto; Former President of Canadian Society for Pharmaceutical Scientists |
 Co-author: László TÓTHFALUSI,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
 Ágnes GYURASICS,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?
 Andrea LASLOP,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
 Emmanuelle VINCENT,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
 Johanna MIELKE,Early Stage Research Fellow, IDEAS Innovative Training Network |
Presentation material
(.PDF, 1 099 KB)
How the increase of assay sensitivity influences the immunogenicity
 Heike WÖHLING,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
 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, 4 080 KB)
27 OCT, 2018 | 3rd DAY SEMINAR in Nanomedicines
MORNING SEMINAR SESSION:
The Era of Biosimilars and Nanosimilars: Current Perspectives
 Raj BAWAPresident 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
 Marina A. DOBROVOLSKAIA,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
 Gert STORM,Professor of Targeted Nanomedicine at the University of Utrecht; Professor of Targeted Therapeutics at the MIRA Institute of the University of Twente; The Netherlands |
