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Back to the forum  2018-07-16 07:11 CEST (UTC+2h)
Helmut
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Vienna, Austria,
2018-07-02 00:30

Posting: # 19006
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 BioBridges 2018 – invitation & preliminary program [Conferences / Workshops]

Dear colleagues,

it is starting to be a nice “tradition” to meet once a year in Prague, Czech Republic during BioBridges, Bioequivalence and Development Workshop.
BioBridges 2018 will be held on September 26th/27th and will take place at the Institute of Pharmacology of the First Faculty of Medicine, Charles University, the same location as last year.

Last year, BioBridges 2017 hosted approximately 130 attendees from many countries. Similar to last year, we would like to create an informal meeting at the University with broad opportunity for open, yet fair discussion among regulatory, industrial and academia participants sharing their views on “hot topics”. This year again a lot of new updates of regulatory guidance, concept papers and draft guidelines has been published. The organizing committee cordially invite you to join BioBridges 2018, one and a half day around topics such as:

  • ICH M9 – Guideline in development on BCS-based biowaivers
  • CMDh update – Practical regulatory experience in real life application of the newly issued guidelines
  • Repositioning of existing APIs – new indications, dosing
  • PKWP – BE/PK position on specific questions
  • Requirements for quality documentation for biological IMPDs in clinical trials
  • Locally applied, locally acting products – Topicals
  • Ecotoxicology studies – Return of experience from Veterinary pharmacy and potential gain for Human medicine
  • Acceptance of ‘old’ BE studies – clinical studies in approval of a new application using MRP/DCP from a national application
  • Sponsor duties – Auditing CRO and monitoring of BE studies
  • Evaluation of dissolution similarity – Bootstrap, MSD
  • Excipients – Besides API, excipients are more and more subjects to regulatory questions
Speakers: Henrike Potthast, Bruno Sepodes, Jean-Michel Cardot, Helmut Schütz, Barbora Ladinová, Pieter Guelen, Vít Perlík, Flavian Radulescu, Tomáš Hauser and others.

More information on https://www.pharmacology.cz/.

Please, feel free to share the meeting information with your colleagues, who you feel may contribute to this highly interactive meeting.

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


P.S.: Feel free to taste the last year agenda including access to presentations (password: Bridges2017).
P.P.S.: Questions/replies please directly to [image].

Cheers,
Helmut Schütz
[image]

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