Dear Colleagues,

I am delighted to cordially invite you, on behalf of the BioBridges organizing team, to BioBridges 2025, as usually held on the premises of Charles University in Prague, on September 25–26, 2025.

The setup remains the same; thus, we will have a chance to discuss development cases, draft guidelines, and important new guidelines that may impact our future projects and regulatory lives. Again, we will have an opportunity to share knowledge, opinions, and regulatory updates with all experts from the industry, regulatory authorities, and academia. And do not forget that we will meet again after a year and enjoy the friendly discussions and networking.

Selected topics:

• Biowaivers of all types
• ICH M15: PBPK, IVIVC, pop PK
• CRO practical experience: inflation of guidelines vs EMA guideline and PSBGs – practical experience, unresolved issues, frequent mistakes/misunderstandings
• Frauds in datasets
• ICH M13A reflections and practical use
• ICH M13B
• OIP/nasal: dissolution, MDRS
• Antiacid/drug-drug interactions
• Synthetic peptides
• Complex generics

Please feel free to share the workshop information with your colleagues who might be interested in coming or contributing to this highly interactive meeting.

Kind regards,

Vit Perlik 

on behalf of the BioBridges organizing team