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UPCOMING EVENT:

Join us for discovery, networking, and inspiration and meet world-prominent biosimilar drug development experts at the 3rd Annual Biosimilars Forum. The event provides an open professional discussion with a strong focus on statistical and regulatory perspectives for professionals who are working in and for biosimilars.
Save the date: 25 – 27 October, 2018 / Budapest, Hungary

SOME PROFESSIONAL LECTURES FROM PREVIOUS EVENTS


At the Annual Biosimilars Forum event series, clinicians, statisticians and regulatory representatives gathered together from around the world to share with each other their perspectives on this key topic of research. Some topics of the last two year’s forums included:

2016 OCT.: 1st Annual Biosimilars Forum | Lecture examples:

Design and analysis of biosimilar studies

(3-part course)


Shein-Chung CHOW
Professor, Duke University School of Medicine

Interchangeability of biological drug products

László ENDRÉNYI
Professor Emeritus, University of Toronto (co-author: László TÓTHFALUSI, Associate Professor, Semmelweis Medical University)

The regulator’s view on the totality of evidence for biosimilars

Andrea LASLOP
Unit Head, Austrian Medicines and Medical Devices Agency

Biosimilar development – a statistical assessor’s perspective

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

2017 OCT.: 2nd Annual Biosimilars Forum | Lecture examples:

Scientific factors in biosimilar product development

László ENDRÉNYI
Professor Emeritus of University of Toronto

Open issues in the assessment of bioequivalence and biosimilarity

Helmut Schütz
Owner at BEBAC – Consultancy Services

Immune side effects of biologicals and nanomedicines

János SZEBENI
Director of the Nanomedicine Research and Education Center at Semmelweis University

Regulatory keynote lecture: 12 years of biosimilars in Europe

Andrea LASLOP
Unit Head, Austrian Medicines and Medical Devices Agency

TESTIMONIALS

  • Bring the Regulators and Producer Companies together into one room is an excellent idea and a beautiful concept.

    –Bernd JILMA | Vice Chair, Department Clinical Pharmacology, Medical University of Vienna

  • I think it’s very nicely covers the whole biosimilar development process… Broader roles could benefit from this conference!

    –Ildikó ARADI | Head of Clinical Development of Biologics, Gedeon Richter Plc.

  • These conferences are extremely useful, they provide discussions in many problems and issues. I hope very much that the series will continue …

    –László ENDRÉNYI | Professor Emeritus of Pharmacology and Biostatistics, University of Toronto

  • The Organizers really done a very good job trying to put together such a conference where we can exchange an idea regarding the regulatory approval process and also on some actual issues in the biosimilar drug development process.

    –Shein-Chung CHOW | Professor, Duke University School of Medicine

  • These meetings, where experts are coming together from the same or different countries bring something new: collaborations, new knowledge, so this is very precious.

    –János SZEBENI | Director of the Nanomedicine Research and Education Center at Semmelweis University

1st Lesson video (available now):

Unequal carry-over – “solved” in BE but still an issue in assessing biosimilarity?

EXCLUSIVE CONTENT – free video lecture series

Watch for free the presentations from the 2nd Biosimilars Forum

Sign up and watch all of the presentation videos recorded at the 2nd Biosimilars Forum for free. Progress your learning from the World’s prominent biosimilar drug development experts.

This video lecture series includes all of the professional courses & lectures delivered at the 2nd Biosimilars Forum relating to actual issues / challenges of follow-on biologics and guidance for their handling. The 1st lesson of the 3-part course about the ‘Open issues in the assessment of bioequivalence and biosimilarity’ lectured by Helmut SCHÜTZ is available now.

SOME INTERNATIONAL BIOSIMILAR EXPERT SPEAKERS FROM OUR PREVIOUS FORUMS

Shein-Chung CHOW
Professor, Department of Biostatistics and Bioinformatics, Duke University School of Medicine
(Lecturer of the 1st Annual Biosimilars Forum, 2016)

László ENDRÉNYI
Professor Emeritus of Pharmacology and Biostatistics, University of Toronto; Former President of Canadian Society for Pharmaceutical Scientists
(Lecturer of the 1st and 2nd Annual Biosimilars Forum, 2016 – 2017)

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
(Speaker of the 2nd Annual Biosimilars Forum, 2017)

Andrea LASLOP
European Regulatory Expert, Unit Head, Austrian Medicines and Medical Devices Agency
(Speaker of the 1st and 2nd Annual Biosimilars Forum, 2016-2017)

Bernd JILMA
Vice Chair, Department Clinical Pharmacology, Medical University of Vienna
(Speaker of the 1st and 2nd Annual Biosimilars Forum, 2016-2017)

Helmut SCHÜTZ
Owner at
BEBAC – Consultancy Services for Bioequivalence and Bioavailability Studies
(Lecturer of the 2nd Annual Biosimilars Forum, 2017)

VIDEO HIGHLIGHTS

Please watch this short videos with the key lecturers and the organizers of the previous forums summarizing their thoughts about the topic and sharing their experiences.

Learn more about the previous events! Click on the links below and take a look at short video interviews with the key lecturers, photo galleries and account of experiences articles of our events.

IMAGE GALLERY | Annual Biosimilars Forums


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ABOUT THE ORGANIZERS

The Annual Biosimilars Forum event series was founded in 2016 by two prestigious Central European scientific societies, the Viennese Section of the IBS and the Hungarian Society for Clinical Biostatistics in cooperation with the Accelsiors CRO Ltd., aimed at increasing effectiveness of clinical research and in order to provide even more effective support in sharing of recent scientific and practical knowledge for biosimilar development professionals and provide an opportunity for a constructive and open dialogue between regulatory professionals, clinical researchers, medical statisticians and pharmaceutical developers.

Viennese Section of the International Biometric Society
The Viennese Section of the International Biometric Society is part of the ROeS, the Austrian Swiss Region of the International Biometric Society (IBS). WBS is an independent, non-profit organization which provides a professional forum for discussions on how to apply statistical methods in biological and medical science.

Hungarian Society for Clinical Biostatistics
The Hungarian Society for Clinical Biostatistics is a national group of the International Society for Clinical Biostatistics (ISCB). One of its aims is to stimulate research of principles and methodologies used in the design and analysis of clinical trial.

Acccelsiors CRO Ltd.
Accelsiors – as a scientific driven CRO – has been a committed supporter of biosimilar drug development, many of their professionals were involved into biosimilar drug development from the early beginnings, guided and managed the first biosimilar drug development projects and professionally supporting clinical trials as well as registration in this innovative field and being active in the clinical research arena in the past two decades.