This 2-day series of events consists of a professional COURSE DAY and a SYMPOSIUM DAY, comprising burning issues in Biosimilar development with a dedicated focus on the statistical and regulatory aspects of follow-on biologics.
During these two interactive days the forum ensures maximum knowledge transfer among professionals, regulators and leading subject matter experts in biosimilar development to exchange and elaborate on the best practices and debate the evolving landscape, pitfalls and current perspectives of biosimilars.
SYMPOSIUM DAY PROGRAMME 18 OCT
Some highlighted topics from the programme of the Symposium day:
- Scientific factors in biosimilar product development
- Special Regulatory Session on hot topics
- Recent developments and best practices in assessing biosimilarity
- Clinical study designs
- and much more with constructive professional exchanges about the current prespectives, development trends, burning issues and challenges of biosimilars
As in previous years, visitors can take part in the event with world-prominent subject matter experts from the fields of regulatory, academic and clinical research, who will be providing a detailed overview of current development issues of follow-on biologics and guidance for their handling. The final programme for the Symposium day is under preparation, the list of speakers will continue to expand until October with internationally renowned experts from the biosimilars area. Please discover some examples from the developing programme of this year’s Forum below:
New in 2019
Special Regulatory Session on hot topics
an open, structured discussion within a round table framework with the participation of renowed regulatory expert speakers and panel members from several regulatory agencies around Europe. Here you can find the first speakers who have already accepted our invitation and some of their regulatory session topics for presentations and discussions (this list will be expanded soon).