Dear Colleagues,

The time has come, and we are pleased to announce BioBridges 2024. It will be an honor to carry on what we have started and again enjoy the opportunity to provide you with a platform to share knowledge, opinions, and regulatory updates among experts from industry, regulatory authorities, and academia.

I am delighted to cordially invite you, on behalf of the BioBridges organizing team, to BioBridges 2024, as usually held on the premises of Charles University in Prague, on September 26–27, 2024. We will discuss development cases, draft guidelines, and important new guidelines that may impact our future projects, efforts, and regulatory lives. And not to forget, we will meet again after a year and enjoy friendly discussions.

Selected topics:

• ICH M15 Model-Informed Drug Development – General Principles Guideline 
• Biosimilars – new guideline for in vivo waivers 
• NTIDs – alpha inflation
  
• OIP – draft guideline 
• Update on Product-specific bioequivalence guidance, African Medicines Agency, and others 

Selected speakers:

• René Anour
• Paulo Paixão
• Carolien Versantvoort
• Pavel Farkaš
• Loice Kikwai
• and others

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

We look forward to meeting you in Prague!

Vit Perlik 

on behalf of the BioBridges organizing team