Welcome

Dear colleagues,

Last year we have organized an informal meeting about BA/BE and dissolution http://www.pharmacology.cz/archive/

It was very successful meeting hosting approximately 90 attendees from many countries. The past year was very rich in updates of regulatory guidance, concept papers and draft guidelines. Therefore, we feel it would be beneficial to continue with a constructive discussion between the players in the private and public pharmaceutical domain.

Herein, Jean Michel Cardot, Helmut Schütz, Ondřej Slanař, Vít Perlík and Marika Pečená would like to cordially invite you to join BioBridges 2017, one and a half day "family reunion" of professionals in the field of bioequivalence and development of pharmaceuticals. The meeting is designed free for open discussion around the current burning issues and for sharing the best practices among industry professionals, regulators and scientists. The topics on the agenda include:

  • Fixed dose combinations with an update on the guideline of the clinical development of fixed combination medicinal products
  • Reflection paper on dissolution specification for generics
  • Reflection paper on Modeling, statistical methodology used for drug development
  • Draft guideline on locally applied and acting drugs in GIT (in vitro/in vivo)
  • Biosimilars
  • BCS based biowaivers regional differences

Speakers: Jean Michel Cardot, Jiri Hofmann, Paula Muñiz, Sandra van Os, Paulo Paixão, Vít Perlík, Henrike Potthast, Helmut Schütz, Milena Stein and others.

Similar to last year, the workshop will take place on September 21-22, 2017 in Prague, Czech Republic at the Institute of Pharmacology of the First Faculty of Medicine, Charles University in Prague.

There will be no official meeting fee, however we kindly ask for your contribution to cover the expenses of the workshop as follows: Industry professionals - 300 EUR, Academia and Regulatory professionals - 50 EUR, Graduates and PhD Students - 20 EUR. The contribution covers, in addition to the lecture hall, two lunch meals and coffee refreshment throughout the workshop.

Further information will be provided. Please, feel free to share the meeting information with your colleagues, who you feel may contribute to this highly interactive and open-access meeting. All open minded professionals are welcomed!

Kind regards,

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

BioBridges Workshop Team