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  • Robust methods for assessment of average and scaled average bioequivalence

Professor, Statistical Consultation Unit, Department of Mathematical Statistics and Actuarial Science, University of the Free State, South Africa

Senior Lecturer, Department of Statistics, University of Pretoria, South Africa

Presentation material
(.PDF, 2 125 KB)

18 OCT, 2019 | 2nd DAY SYMPOSIUM: Clinical Research and Regulatory

  • Balaam’s Design Revisited

Chief Scientific Officer, Accelsiors CRO Ltd.;
President of the Hungarian Society for Clinical Biostatistics, Hungary

Co-author: Joëlle MONNET GAUD
Director, Biostatistics,
Fresenius-Kabi SwissBioSim GmbH, Switzerland

Presentation material
(.PDF, 941 KB)

  • Measuring switchability using observational data

Associate Professor,
Faculty of Pharmacology, Semmelweis Medical University, Hungary

Co-author: László ENDRÉNYI
Professor Emeritus of Pharmacology and Biostatistics, University of Toronto; Former President of Canadian Society for Pharmaceutical Scientists, Canada

Presentation material
(.PDF, 1 330 KB)

  • Applications of the expected power (statistical assurance) for bioequivalence trials

Professor of Statistics, University of the Free State, South Africa;
Head of Biometrics and Statistical Programming, medac GmbH, Germany

Presentation material
(.PDF, 3 598 KB)

  • Regulatory Keynote:
    Current challenges in the development of biosimilars

Head of Scientific Office, Austrian Medicines and Medical Devices Agency (AGES), Austria; Member of the Scientific Advice Working Party (SAWP) of the European Medicines Agency; Austrian delegate in the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency

Presentation material
(.PDF, 1 217 KB)

  • Regulatory reflections on biosimilar development and statistical methods used at quality level

Ina-Christine RONDAK
Biostatistician, Seconded National Expert from Klinikum rechts der Isar of Technische Universität München to EMA, Germany

Presentation material
(.PDF, 779 KB)

  • Quality and statistics: bringing two worlds together

Andreas BRANDT
Statistical assessor,
Federal Institute for Drugs and Medical Devices (BfArM), Germany

Presentation material
(.PDF, 1 607 KB)

  • Is similarity different? – Recent developments from the regulatory perspective

Stephan LEHR
Biostatistician, Austrian Medicines and Medical Devices Agency (AGES);
Assessor, EMA Biostatistics Working Party; Alternate Member, EMA Scientific Advice Working Party; Former President of the Viennese Section of the International Biometric Society, Austria

Presentation material
(.PDF, 732 KB)

  • Leaflet of the 4th Annual Biosimilars Forum with Agenda

Leaflet of the Forum
(.PDF, 1 965 KB)

We had a successful and professionally fruitful event together in this year.
If you need more professional help or support regarding biosimilar drug development, do not hesitate to contact Accelsiors’ Biosimilar Research Team!