Welcome

Dear colleagues,


It is hard to believe, however the year has passed and is time to plan next BioBridges 2019. The workshop BioBridges 2018 was very successful, hosting nearly 200 attendees and after the meeting we have received very positive feedback.
This gives us hope that it make sense to carry on with what we have started some time ago i.e. establishing a platform for informal, kind, yet hopefully professional exchange of opinions and updates among industry, regulators and academia.
Therefore, in behalf of the organizers of BioBridges 2019, I would like to kindly invite you to join us this year again. The meeting takes place at the same location, Charles University, Prague in September 26-27, 2019. We keep the same logic and set up of the event with the aim to discuss draft guidelines and guidelines which may impact our future development efforts and regulatory lives.

The program topics we would like to cover this year are:

  • ICH M9 - BCS Guideline - overview of comments/final version
  • EMA Scientific Advices
  • Draft guideline on quality and equivalence of topical products
  • Well established use procedures
  • Product specific BE guidelines
  • Dissolution for specific products, vaginal rings, suspensions, IVIVC
  • ICH M10 Bioanalytical Method Validation - overview of comments
More information will be released soon on https://www.biobridges.eu/
Please, feel free to distribute the information about the meeting to your colleagues, who you feel might be interested to come and who may contribute to this highly interactive meeting.

Kind regards,

Jean Michel Cardot, Vít Perlík, Marika Pečená, Helmut Schütz and Ondřej Slanař
BioBridges Workshop Team