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Download All Presentation Materials of the 4th Annual Biosimilars Forum

The materials of the professional presentations delivered by leading biosimilar research experts at the 4th Annual Biosimilars Forum are available to download as a courtesy of the event series. Don’t miss out, this exclusive offer is available only for a couple of weeks!

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Learn From Leading Drug Development Experts!

Inside you will find all the presentation materials delivered during the 4th Biosimilars Forum by subject matter experts from the fields of regulatory, academic and clinical research (17-18 OCT, 2019).

These lectures provide essential information for research management, leadership and support teams working in and for biosimilar drug development:

  • A detailed overview of recent development issues of follow-on biologics and guidance for their handling
  • Lectures in advanced biostatistical methodologies
  • with a strong focus on the statistical and regulatory aspects of biosimilar research

100% free. Sign up in 30 seconds and we will email you an access to the essential lectures in biosimilar development within 1 business day.

List of Presentations

Professional short course (111 pages)

Robust methods for assessment of average and scaled average bioequivalence

Robert SCHALL
Professor, University of the Free State, South Africa
Divan BURGER
Senior Lecturer, University of Pretoria, South Africa

 Theoretical considerations (13 pages)

Balaam’s Design Revisited

Júlia SINGER
Chief Scientific Officer, Accelsiors CRO Ltd., Hungary
Co-author: Joëlle MONNET GAUD
Director, Biostatistics, Fresenius-Kabi SwissBioSim GmbH, Switzerland

 Theoretical considerations (17 pages)

Measuring switchability using observational data

László TÓTHFALUSI
Associate Professor, Semmelweis University, Hungary
Co-author: László ENDRÉNYI, Professor Emeritus of Pharmacology and Biostatistics, University of Toronto, Canada

 Theoretical considerations (31 pages)

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

Arne RING
Head of Biometrics and Statistical Programming, medac GmbH, Germany

 Regulatory Questions – Keynote (18 pages)

Current challenges in the development of biosimilars

Andrea LASLOP
Head of Scientific Unit, Austrian Medicines and Medical Devices Agency, Austria

 Regulatory Questions (32 pages)

Quality and statistics: bringing two worlds together

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

 Regulatory Questions (20 pages)

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

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

 Regulatory Questions (18 pages)

Is similarity different? – Recent developments from the regulatory perspective

Stephan LEHR
Biostatistician, Austrian Medicines and Medical Devices Agency (AGES), Austria

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