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Back to the forum  Query: 2018-02-20 02:58 CET (UTC+1h)
Vienna, Austria,
2017-07-24 19:57

Posting: # 17603
Views: 3,513

 BioBridges 2017 – invitation & final program [Conferences / Workshops]

Dear colleagues,

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.

  • BCS Biowaivers
    • Henrike Potthast (BfArM): BCS-based biowaivers between different regions, product specification
    • Pieter Guelen (PCS): Biowaivers – industry perspective
  • Regulatory Update on important topics
    • Marina Feřtek (SÚKL): Fixed dose combinations
    • Milena Stain (AGES): Biosimilars
  • In vitro/In silico as in vivo surrogate
    • 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

  • Dissolution
    • 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.

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.

All open minded professionals are welcomed!

Kind regards,
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)

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It is nice to know that the computer understands the problem.
But I would like to understand it too.    Eugene Wigner

BEBAC Ing. Helmut Schütz