Bioequivalence and Bioavailability Forum

Dear colleagues,

it is hard to believe, however, the year has passed and is time to plan BioBridges 2019. The workshop BioBridges 2018 was very successful, hosting nearly 200 attendees and after the meeting we have received very positive feedback.

This gives us hope that it makes sense to carry on with what we have started some time ago, i.e., establishing a platform for informal, kind, yet hopefully professional exchange of opinions and updates among industry, regulators, and the academia.

Therefore, on behalf of the organizers, I would like to kindly invite you to join us this year again. The meeting will take place at the same location, Institute of Pharmacology of the First Faculty of Medicine, Charles University, Prague in September 26–27, 2019. We keep the same logic and set up of the event with the aim to discuss draft guidelines and guidelines which may impact our future development efforts and regulatory lives.

The program topics we will cover this year are:

• ICH M9 – BCS guideline – overview of comments/final version
  
• EMA scientific advices
  
• Draft guideline on quality and equivalence of topical products
  
• Well established use procedures
  
• Product specific BE guidelines
  
• Dissolution for specific products, vaginal rings, suspensions, IVIVC
  
• ICH M10 – Bioanalytical method validation – overview of comments

Speakers

Susana Almeida (Medicines for Europe ), René Anour (AGES, Expert Group Coordinator “Scientific Ad­vice” ), Alasanne Ba (CHM-P  ), Jean-Michel Cardot (University Clermont Auvergne ), Maria Cruz Catur­la (Ana­pharm ), Paola Cop­pola (MHRA ), Marina Feřtek (Consultant ), Jiři Hofmann (Zentiva ), Jana Klimasová (SÚKL ), Nathalie Masson (Uni­ther ), Martina Nora Odlo­ži­lí­ko­vá (Consultant ), Paulo Paixão (University Lisbon ), Hen­rike Potthast (BfArM, CHMP PKWP ), Flavian Radu­lescu (University of Medicine and Pharmacy Bucharest ), Volo­dy­myr Stus (Polpharma ), Philip Timmerman (European Bioanalysis Forum ).

More information, updates and registration on BioBridges 2019.

Please, feel free to distribute the information about the meeting to your colleagues, who you feel might be interested to attend and who may contribute to this highly interactive meeting.

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

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Edit: Presentations are available for download.