INTRODUCTION & AIM OF THE WORKSHOP
Immunogenicity assessment has become a critical component of the development and regulatory evaluation of therapeutic proteins, biosimilars and emerging modalities. Over the past decade, regulatory guidance has evolved considerably, with dedicated recommendations now available from the FDA, EMA, NMPA (China) and other health authorities.
Although these guidelines share many common scientific principles, important differences remain in expectations regarding assay strategies, data interpretation and the clinical application of immunogenicity results. For companies conducting global development programmes, these differences often lead to additional complexity without necessarily improving scientific understanding or patient benefit.
This Focus Workshop aims to move beyond a comparison of regional regulations and instead identify the scientific principles that should underpin immunogenicity assessment worldwide and support the development of globally harmonised, science-driven best practices.
We invite abstracts for presentations that align with the workshop’s key themes:
- Global Regulatory Perspectives – Where Do We Align and Where Do We Differ?
- Clinical Relevance of Immunogenicity
- Towards Science-Driven Best Practices
- Future Directions
Submissions outside these themes can be considered if they address other relevant AI challenges or opportunities in BioA.
More information can be found here
Abstract Submission Deadline: 21-MAR-2027
Submit your abstract at using this form
Abstracts will be evaluated based on relevance, innovation, and alignment with the workshop’s objectives. Acceptance notifications will be sent before 05-APR-2027.
The meeting will be held at the NH Málaga, Spain.
For your travel planning, the meeting will start at 09:00 CET on June 17 and will end around 16:30 CET on June 18.
We will negotiate conference rates with the NH hotel. A reservation link will be added later.
All delegates will need to make their own hotel reservations. Hotel reservations are independent from the EBF.
Registration will open on February 15th, 2025.
A reservation link will be provided in this tab.
For maximum interaction, the meeting attendance is capped to 80 delegates and 3 delegates per organisation (excluding presenters).
To register for the meeting use this link
Registration includes entrance to the meeting, lunches/coffee breaks.
The registration fee = 680 Euro. There will be no early bird rate nor 1-day passes.
For maximum interaction, the meeting attendance is capped to 90 delegates and 3 delegates/company (excluding presenters, for which the registration fee will be waived)
Cancellation policy:
Cancellation needs to be done 14 days before the meeting start date.
Payment of the full conference fee will be required if cancelled after that date or on “no-show”.
As announced earlier, we have reached the maximum capacity of the Workshop (80 delegates)
Registration is now closed.
You can sign up for the waiting list in case we have a cancelation before 31 May (to allow you to still plan your travel).
For more info, please contact admin@e-b-f.eu