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Exclusive video lecture series in biosimilar development

Sign up and watch for free the professional lectures delivered at the 2nd Biosimilars Forum by subject experts of this complex development field.

The 7th video presentation, entitled Regulatory perspective on comparison of quality attributes in drug development lectured by Ina-Christine RONDAK (Biostatistician, Seconded National Expert from Klinikum rechts der Isar of Technische Universität München to EMA), is available now.

Start to learn from leading biosimilar development experts! This video series provide a detailed overview about actual issues of follow-on biologics and guidance for their handling. It is essential for research management, leadership and support teams working across biosimilar drug development.

 Video Lesson 7 | Available now

100% free. Sign up in 30 seconds and get free access to this essential video lecture series in biosimilar development.

The full-length presentation videos of the series include the professional courses and lectures delivered during the 2nd Biosimilars Forum by leading experts in biosimilar development (webcasting stream recorded on 5-6 OCT, 2017).

  • This lecture series with high-quality video courses and presentations provide:
    • a deep insight into the statistical and regulatory aspects of biosimilar research
    • recent scientific and practical knowledge on the assessment of biosimilar products
    • with an open discussion about recent development challenges of biosimilars and guidance for their handling
  • Delivered by leading biosimilar development experts from around the world:
    • regulatory professionals
    • medical scientists
    • academicians
    • biostatisticians
    • clinical researchers
    • pharmaceutical developers
Get your free access to the video lectures

How does it work? The first 7 video lessons are available now. Sign up by filling out this form and we will email you access for this presentation streams within 1 business day. Each videos of the series will arrive every 2 weeks. The organizers of the Biosimilars Forum will notify you by email when the following presentation is available to watch:

LIST OF VIDEO LECTURES OF THE SERIES

3-part course: Open issues in the assessment of bioequivalence and biosimilarity

 Available |    53:37

1st Lesson of the course:

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

 Available |    52:05

2nd Lesson of the course:

Multi-Group and Multi-Site Studies. To pool or not to pool?

 Available  |    1:39:40

3rd Lesson of the course (with 2 topics):

Group-Sequential and Two-Stage Designs / Reference-scaling and Control of the Type I Error

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

 Available |    33:25

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

Johanna MIELKE
Biostatistician,
Novartis Pharma AG

 Available |     1:04:35

Scientific factors in biosimilar product development

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

 Available |     32:45

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

László TÓTHFALUSI
Associate Professor, Faculty of Pharmacology, Semmelweis University / Co-Author: László ENDRÉNYI, Prof. Emeritus of University of Toronto

 Available NOW |     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

 Coming: Early AUG |    51:02

Keynote Presentation: Nanosimilar development:

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

 100% FREE!

Don't miss this special opportunity!

Sign up in 30 seconds and get an access to this essential video lecture series in biosimilar development.


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