Invitation

Dear Colleagues,

A lot has happened, professionally and personally, since we had a chance to meet during the last BioBridges 2019. We all had to put up with two years of staying at our homes, living mostly online, but fortunately, life is returning to what it was before the Covid-19 pandemic, and we are happy to announce that also BioBridges is back this year. The workshops during previous years were very successful, hosting nearly 200 attendees and receiving very positive feedback; please see our Archive.

The opportunity to carry on with what we started some years ago makes us happy and gives us hope that we are providing a platform to informally but still professionally share knowledge, opinions, and regulatory updates among industry, regulators, and academia.

Therefore, on behalf of the organizers of BioBridges 2022, I cordially invite you to join us again this year. The meeting will take place at the same location as before, Charles University, Prague, on September 22–23, 2022. The concept of the event will be the same, to discuss development cases, draft guidelines, and guidelines that may impact our future projects, efforts, and regulatory lives.

BioBridges are based on rich, live face-to-face interactions and exchange of ideas, nevertheless, should you prefer online participation as the only solution to join us, please contact us.

The topics we would like to cover this year are:

Bridging the EU and UK development data
ICH M13 BE guideline
Dissolution data evaluation – bootstrapping
Dissolution data for enteric-coated products – QndA
LALA/OIP in vitro data evaluation 0.9–1.11
NTIs – scaling
Product specific guidelines
WEU products in reality

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

Kind regards
BioBridges Workshop Team