VIDEO PRESENTATIONS OF THE 2nd ANNUAL BIOSIMILARS FORUM (5-6 OCT, 2017)

© Copyrights: All of these presentation videos and materilas available this page 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.

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

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

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

 Case Study |    32:45

Algorithms for evaluating reference scaled average bioequivalence: power, bias and consumer risk

László TÓTHFALUSI
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

 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

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

 Discussion |     1:54:18

Round Table Session

Modarator: Stephan LEHR
Biostatistician, Austrian Medicines and Medical Devices Agency;
President, Viennese Section of IBS