IMAGE GALLERY | Annual Biosimilars Forums


SOME PROFESSIONAL LECTURES FROM THE PROGRAMS OF THE 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 actual topic of research. Some topics of the last two year’s forums:

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

Regulatory keynote lecture: 12 years of biosimilars in Europe

Andrea LASLOP, Unit Head, Austrian Medicines and Medical Devices Agency

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SPEAKERS OF THE 2nd ANNUAL BIOSIMILARS FORUM

SPEAKERS AND LECTURES
Some specialists who have already accepted our invitation to participate in the forum. The program of the event will be supported and complemented by several additional international experts. The final agenda and the list of lectures and speakers of the 2nd Biosimilars Forum is under preparation.

Dr. László ENDRÉNYI
Professor Emeritus of Pharmacology and Statistics, University of Toronto;
Former President of Canadian Society for Pharmaceutical Scientists

Title of lecture:

“Scientific factors in biosimilar product development”

Helmut SCHÜTZ
Owner at
BEBAC – Consultancy Services for Bioequivalence and Bioavailability Studies

Title of course:

“Open issues in the assessment of bioequivalence and biosimilarity”

Andrea LASLOP
Unit Head,

Austrian Medicines and Medical Devices Agency

Title of keynote presentation:

“12 years of biosimilars in Europe:
What is the exposure and response in our learning curve?”

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

Title of lecture:

“Investigating PK/PD in the steep ascending part of the dose response curve”

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

Title of lecture:

“Statistical considerations in the biosimilarity assessment of quality attributes”

Johanna MIELKE

Biostatistician,
Novartis Pharma AG
 

Title of lecture:

“Clinical trials for biosimilars in Europe: an updated systematic comparison of the
clinical development programs”

Ágnes GYURASICS
Chief Medical Counselor, National Institute for Pharmacy and Nutrition (Hungary)

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  • … the development of biosimilars is heading for a great future …

    –Prof. Shein-Chung Chow, PhD (Duke University School of Medicine)

  • Right now there is a major concern that the EU and US licenced reference products are not really similar in some cases.

    –Prof. Shein-Chung Chow, PhD (Duke University School of Medicine)

  • The pathways are very-very different in the European Union and the United States. In Europe they go almost product by product and there are some guidelines for each product class. In the United States they try to have a big encompassing legislation which covers everything – and it cannot.

    – Prof. Dr. László Endrényi (University of Toronto)

  • There is still some lack in some areas where there could be more guidance…

    –Stephan Lehr (President, Viennese Section of IBS)

Sub Title

Main Title


  • Algorithms for evaluating reference scaled average bioequivalence: Power, bias and consumer risk
presented by László TÓTFALUSI
(Associate Professor, Faculty of Pharmacology, Semmelweis University of Budapest)
and László ENDRÉNYI
(Professor Emeritus of Pharmacology and Statistics, University of Toronto; Former President of Canadian Society for Pharmaceutical Scientists)

2-DAY EVENT

 

5-6 OCT, 2017

300 EUR + VAT

~93 000 HUF + VAT

per delegate

2-DAY EVENT
for WBC & ISCB members

5-6 OCT, 2017

250 EUR + VAT

~77 500 HUF + VAT

per delegate

Price excluding VAT (+27% VAT will be applicable)

Fee includes refreshments, lunch and conference material for the event

1st DAY COURSE only

5 OCT, 2017

250 EUR + VAT

~77 500 HUF + VAT

per delegate

Price excluding VAT (+27% VAT will be applicable)

Fee includes refreshments, lunch and conference material for the event

2nd DAY SIMPOSIUM only

6 OCT, 2017

100 EUR + VAT

~31 000 HUF + VAT

per delegate

Price excluding VAT (+27% VAT will be applicable)

Fee includes refreshments, lunch and conference material for the event

2nd DAY SIMPOSIUM only for WBC & ISCB members

6 OCT, 2017

For FREE

~0 HUF + VAT

per delegate

Price excluding VAT (+27% VAT will be applicable)

Fee includes refreshments, lunch and conference material for the 2nd day of the event

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DOWNLOAD YOUR ESSENTIAL GUIDE IN BIOSIMILAR DEVELOPMENT FOR FREE

Everything You Need to Know About Biosimilar Study Design and Analysis

3-part SCIENTIFIC COURSE presentation
by Prof. Shein-Chung Chow, PhD

Professor at Duke University School of Medicine
The 1st lecture is available now. Courtesy of Annual Biosimilars Forum event series.