Posting: # 17603
BioBridges 2017 – invitation & final program [Conferences / Workshops]
last year we have organized an informal meeting about BA/BE and dissolution. It was very successful meeting hosting approximately 90 attendees from many countries. The past year was 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 second one and a half day “family reunion” of professionals in the field of bioequivalence and development of pharmaceuticals. The workshop is designed free for open discussion around the current burning issues and for sharing the best practices among industry professionals, regulators and scientists.
Regulatory Update on important topics
- BCS Biowaivers
- Henrike Potthast (BfArM): BCS-based biowaivers between different regions, product specification
- Pieter Guelen (PCS): Biowaivers – industry perspective
In vitro/In silico as in vivo surrogate
- Marina Feřtek (SÚKL): Fixed dose combinations
- Milena Stain (AGES): Biosimilars
- Sandra van Os (Synthon): Draft guideline on locally applied and acting drugs in GIT (in vitro/in vivo)
- Jean-Michel Cardot (Université d’Auvergne): Reflection paper on Modeling, statistical methodology used for drug development
- Helmut Schütz (BEBAC): How to design a pilot study – extrapolation of results
- Vít Perlík (PharmInvent): Regulatory Year in review – new draft guidelines
- Ivana Taševská (SÚKL): Reflection paper on dissolution limits
- Jiří Hofmann (Sanofi/Zentiva): Reflection paper on dissolution specification for generics
Similar to last year, the workshop will take place on September 21–22 in Prague, Czech Republic at the Institute of Pharmacology of the First Faculty of Medicine, Charles University.All open minded professionals are welcomed!
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 €, Academia and Regulatory professionals – 50 €, Graduates and PhD Students – 20 €. The contribution covers, in addition to the lecture hall, two lunch meals and coffee refreshment throughout the workshop.
Please indicate your interest by responding to one of the addresses given at the end at your earliest convenience. 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.
Jean-Michel Cardot (University Auvergne, Clermont-Ferrand), Helmut Schütz (BEBAC, Vienna),
Ondřej Slanař (Charles University, Prague), Vít Perlík (PharmInvent, Prague), Marika Pečená (Quinta Analytica, Prague)