3rd Global Bioequivalence Harmonization Initiative

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The 3rd Global Bioequivalence Harmonization Initiative (GBHI) conference will feature regulatory, academic, and industry speakers from North America and Europe as well as speakers from regulatory agencies from Asia (e.g. China) and South America (e.g. Brazil) at the Novotel Amsterdam City,  in Amsterdam, The Netherlands from April 11-13, 2018.

Bioequivalence (BE) assessment is the essential basis for approval of generic drug products worldwide. However, the requirements and standards can vary greatly on a number of issues between the regions. This not only complicates the approval process for the pharmaceutical industry, but it can impede a comparison between products registered and marketed in different parts of the world. BE-related topics selected for discussion include investigation of BE of pro-drugs and compounds with extensive pre-systemic extraction; study design and statistical considerations for highly variable drugs; and the question of when it is appropriate to exclude certain PK results from the BE evaluation.

The 2018 conference themes include: 

  • Necessity of multiple dose studies in BE testing
  • BE assessment of transdermal patches including adhesion and skin sensitization/ irritation studies
  • Liposomal parenteral preparations

 

Best wishes for a fruitful meeting with intensive scientific exchange and discussions!

 

Prof. Dr. Erem Bilensoy                                                                       Dr. Henning Blume

EUFEPS President                                                                                                          Congress Chairman

 

12.04.2018 09:00 Uhr   through   13.04.2018 17:00 Uhr
Europaboulevard 10
1083 AD Amsterdam,
Netherlands
Phone: (+31)20/7219179