2nd Annual Biosimilars Forum – hosted by Accelsiors
5-6 OCT, 2017
Accelsiors CRO | Event Hall, 103. Haros Street, 2nd floor, 1222 Budapest, Hungary
Join us in Budapest on 5-6 October for our 2nd Annual Biosimilars Forum regarding hot topics related to the drug development of Bio- and Nanosimilars with a strong scientific FOCUS ON Statistical and Regulatory perspectives.
This is our 2nd annual event, with the participation of scientific experts and prominent professionals from the field of clinical research
Accelsiors CRO Ltd. has partnered with the Viennese Section of the International Biometric Society and the Hungarian Society for Clinical Biostatistics once again to deliver this scientific forum for research management, leadership and support teams working in and for biosimilar drug development.
This unique forum, a continuation of the very successful 1st Annual Biosimilars Forum in Budapest from last year – will cover important issues and specific areas of debate facing clinical development teams. It is particularly useful for those who are interested in constructive and open dialogue between medical statisticians, regulatory professionals, clinical researchers and sponsors with whom they collaborate.
Focus on the most actual challenges of Bio- and Nanosimilar development
This two-day series of events consists of a day-long course (October 5th) and a professional symposium (invited presentations and round table session, scheduled for October 6th) comprising hot topics related to the drug development of biosimilars. The program of the event will be supported and complemented by international experts.
5th October, 2017 | COURSE with special lecturers
• "Scientific factors in biosimilar product development” – The lecture is presented by:
László ENDRÉNYI (Professor Emeritus of Pharmacology and Biostatistics, University of Toronto, Former President of Canadian Society for Pharmaceutical Scientists)
• “Open issues in the assessment of bioequivalence and biosimilarity” – The course is lectured by:
Helmut SCHÜTZ (Owner at BEBAC – Consultancy Services for Bioequivalence and Bioavailability Studies)
6th October, 2017 | Professional SYMPOSIUM and ROUND TABLE
Planned topics for presentations and discussions with a professional focus on Statistical and Regulatory Perspectives in Biosimilar Development:
• EMA "Statistics for quality comparison" reflection paper is out for public consultation
• Recent developments in assessing biosimilarity
• Update on the last year review of the development program of registered Biosims in the EU (based on the EPARs)
• 12 years of biosimilars in Europe: What is the exposure and response in our learning curve? - presented by Andrea LASLOP
+ One more planned keynote presentation about NANOSIMILAR development will be presented by an invited special expert of this innovative field (Under preparation)
We look forward to meeting you on 5th - 6th of October, 2017 at Accelsiors Event Hall in Budapest! Don't forget to register for this informative forum regarding advances in Biosimilars because places are limited in number.
Please, visit the dedicated website of the event to learn more at www.biosimsforum.com!