3rd Conference of the Global Bioequivalence Harmonization Initiative (GBHI)
The third conference of the GBHI meeting series was held on April 12 - 13, 2018 in Amsterdam, The Netherlands.
The main topics of the conference included:
Wrap-up of the last conference in Washington (2016) for all those who could not participate there
Necessity of multiple dose studies in BE testing in the view of EU and US regulations
BE assessment of transdermal patches including adhesion and skin sensitization/ irritation studies
Liposomal parenteral preparations discussing authorities‘ perspectives and scientific aspects
Here you can download the final version of the program.
The scientific and planning committee members:
| Mehul Mehta, US-FDA, Washington, USA (Chair) | Andreas Kovar, Sanofi, Frankfurt, Germany |
| Henning Blume, SocraTec C&S, Oberursel, Germany (Chair) | Henrike Potthast, BfArM, Bonn, Germany |
| Erem Bilensoy, Hacettepe University, Ankara, Turkey | Barbara Schug, SocraTec R&D, Oberursel, Germany |
| Gerald Beuerle, Teva - Ratiopharm, Ulm/Germany | Tomas Salmonson, MPA, Uppsala, Sweden |
| Mei-Ling Chen, US-FDA, Washington, USA | Nilufer Tampal, US-FDA, Silver Spring, USA |
| Barbara Davit, US-FDA, Washington, USA | Yu-Chung Tsang, Apotex, Toronto, Canada |
| Angelica Dorantes, US-FDA, Silver Spring, USA | Jan Welink, MEB, Utrecht, The Netherlands |
| Wenlei Jiang, US-FDA, Silver Spring, USA | Clive Wilson, Strathclyde University, Glasgow, Scotland |
Conference Report
The conference report was published at the European Journal of Pharmaceutical Sciences (Eur J Pharm Sci) in May 2020. Here you can download the article: