3rd Annual Biosimilars Forum – hosted by Accelsiors
Date: 25 - 26 OCT, 2018;
Venue: Accelsiors CRO | Event Hall, 103. Haros Street, Budapest, Hungary;
Join us for discovery, networking and inspiration at our 3rd professional event, and focus on statistical and regulatory perspectives in biosimilar development with leading experts from the fields of regulatory, academic and clinical research.
Based on the success of the last years’ events, the Viennese Section of the International Biometric Society and the Hungarian Society for Clinical Biostatistics have partnered with Accelsiors CRO once again to deliver the 3rd Annual Biosimilars Forum for research management, leadership and support teams working in and for biosimilar drug development.
The unique specialty of this professional forum is that it brings together regulators, medical scientists, clinical researchers and pharmaceutical development companies from around the world to provide an opportunity for a constructive dialogue related to the specific challenges of biosimilar development.
This two-day series of events consists of a Course day with two professional masterclass sessions and a Symposium day (invited presentations, contributed presentations and posters and round table discussion), comprising issues in biosimilar development. This year’s event will cover important issues and specific areas of debate facing clinical development teams specialized in biosimilar development with a strong focus on statistical and regulatory perspectives.
New this year: a contributed paper session and a poster session is planned to be organized, based on the abstracts received. Abstract proposals for both sessions are awaited, details and suggested topics are available at biosimsforum.com.
Some specialists who accepted the invitation to participate at the 3rd Annual Biosimilars Forum:
The event will provide a detailed overview of current development issues of follow-on biologics and guidance for their handling.
25th October, 2018 | Professional COURSES with special lecturers
Uni- and multivariate Bioequivalence of PK parameters – The first course session is lectured by:
• Thomas JAKI - Professor of Statistics at Lancaster University, UK; and
• Phillip PALLMANN - Deputy Director Research Design and Conduct Service and Research Fellow at Cardiff University, UK
Preclinical biosimilar assays consider both bioequivalence (PK) and equivalence (surrogate therapeutic endpoints) – The course is lectured by:
• Ludwig A. HOTHORN - Professor of Biostatistics at Leibniz Universität Hannover, Germany
26th October, 2018 | Professional SYMPOSIUM and ROUND TABLE
As in previous years, the programme of the event will be supported and complemented by leading experts from the fields of regulatory, academic and clinical research who will be providing an overview of current regulatory requirements for assessing biosimilarity of biosimilar products and giving detailed guidance to handle differences between regulatory guideline recommendations and clinical research practice.
WBS and ISCB members can attend the 2nd day symposium for free.
Please, visit the dedicated website of the event to learn more at www.biosimsforum.com!
Participation is particularly useful for those who are interested in constructive and open dialogue between regulatory professionals, medical statisticians, clinical researchers and sponsors with whom they collaborate. Tickets are available now with flexible terms at the event’s official website. Please send us your registration as soon as possible because places are limited in number.