Dear Colleagues,

It is a pleasure to invite you to BioBridges 2026, which will take place on September 24–25, 2026, in

Prague, Institute of Pharmacology, First Faculty of Medicine, Charles University. The conference will

again bring together experts from academia, regulatory authorities, and industry to discuss current

scientific and regulatory developments in bioequivalence, biosimilars, and in vitro methodologies.

The programme will include the following sections:

ICH M12, ICH M13B section

• Interactions in general, PPI interaction modelling
• Physiologically based biopharmaceutics modelling

ICH M13A section – methodology for bioequivalence PK studies

• pAUCs in LAI developments
• Alpha adjustment for pooled studies

Biosimilars section

• Update on regulatory landscape – use of in vitro similarity comparison
• Industry perspective and scientific background for current in vitro similarity comparison
• PBPK example

LALA section

• Ophthalmics, Intranasals
• IVPT, IVRT

Confirmed speakers (alphabetical order) are:

René Anour, Jean-Michel Cardot, Peter Caspers, Marina Feřtek, Lida Kalantzi, Esther Lubberts,

Paulo Paixão, Martin Schiestl, Helmut Schütz, Ondřej Slanař, Carolien Versantvoort, and CRO

representative

Please feel free to share the workshop information with colleagues who may be interested in

attending or contributing to this highly interactive meeting. We look forward to welcoming you to

Prague for one and a half days of scientific exchange and practical discussion on current development

and regulatory topics.

Kind regards and ALL THE BEST,

Vit Perlik