It is starting to be a nice "tradition" to meet once a year in Prague during BioBridges, Bioequivalence and Development Workshop. BioBridges 2018 will be held on September 26th/27th and will take place at the 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 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
- Repositioning of existing APIs - new indications, dosing
- PKWP - BE/PK position on specific questions
- Requirements for quality documentation for biological IMPD 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
- Sponsor duties - Auditing CRO and monitoring of BE studies
- Evaluation of dissolution similarity - Bootstrap, MSD
- Excipients - Beside API, Excipient 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.
Jean Michel Cardot, Helmut Schütz, Ondřej Slanař, Vít Perlík, and Marika Pečená
BioBridges Workshop Team
N.B.: Feel free to taste the last year agenda including the access to the presentations.
Presentations from BIOBRIDGES 2017 are ready to be downloaded here.