BioBridges 2019 – invitation & preliminary program [Conferences / Workshops]
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.
- 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
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 ), Marina Fertek (Consultant ), Jiři Hofmann (Zentiva ), Nathalie Masson (Unither ), Martina Nora Odložilíková (Consultant ), Paulo Paixão (University Lisbon ), Henrike Potthast (BfArM, CHMP PKWP ), Flavian Radulescu (University of Medicine and Pharmacy Bucharest ), Jan Welink (MEB, CHMP PKWP ).
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
The quality of responses received is directly proportional to the quality of the question asked. ☼
- BioBridges 2019 – invitation & preliminary program Helmut 2019-06-29 13:06 [Conferences / Workshops]