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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, two days 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: Susana Almeida (Medicines for Europe), Paola Coppola (MHRA), Jean-Michel Cardot (Université d’Auvergne), Marina Feřtek (Consultant), Anders Fuglsang (Fuglsang Pharma), Pieter Guelen (PCS), Sebastian Härtter (Boehringer-Ingelheim), Tomáš Hauser (Zentiva), Stefan Horkovics-Kovats (SHK), Barbora Ladinová (SÚKL), Reynald Magnier (Ceva), Henrike Potthast (BfArM, EMA PKWP), Flavian Radulescu (University of Mecicine and Pharmacy Bucharest), Bruno Sepodes (EMA COMP), Volodymyr Stus (Polpharma), Jan Šůs (Zentiva).

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, Vít Perlík, Helmut Schütz, and Ondřej Slanař.
BioBridges Workshop Team



Programme
Registration
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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