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BioBridges 2017 – invitation [Conferences / Workshops]

posted by Helmut Homepage - Vienna, Austria, 2017-07-24 19:57  - Posting: # 17603
Views: 1,634

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, and Vít Perlík 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 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.
  • BCS-based biowaivers between different regions, product specification.
  • Reflection paper on dissolution specification for generics.
  • Reflection paper on statistical methodology for the comparative assessment of
    quality attributes in drug development.
  • Time scaling in IVIVC.
  • Advances in in silico PK modeling and in vitro validation.
  • Design of pilot studies.
  • Draft guideline on locally applied and acting drugs in GIT (in vitro/in vivo).
  • Biosimilars.

Speakers will come from the industry, academia, and regulatory agencies: Jean-Michel Cardot, Jiří Hofmann, Paula Muñiz, Sandra van Os, Paulo Paixão, Vít Perlík, Henrike Potthast, Helmut Schütz, Milena Stein, Martin Wolfsegger and others. 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), and Vít Perlík (PharmInvent, Prague)



Jean-Michel Cardot <j-michel.cardot[image]udamail.fr>
Helmut Schütz <helmut.schuetz[image]bebac.at>
Ondřej Slanař <ondrej.slanar[image]lf1.cuni.cz>
Vít Perlík <vitperlik[image]gmail.com>
Preliminary booking <info[image]pharmacology.cz>

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