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Global Bioequivalence Harmonization Initiative: EUFEPS-AAPS Second International Workshop

Meeting Information

This meeting will be held on September 15-16, 2016, in Washington, DC.

Location:
Rockville Hotel & Executive Meeting Center
Rockville MD

Goals and Objectives:

The EUFEPS Network on Bioavailability and Biopharmaceutics started this Global Bioequivalence Harmonization Initiative (GBHI), several years ago. The first GBHI Meeting took place in March 2015 in Amsterdam, The Netherlands. It was a very successful one due to the active contributions of key regulatory scientists from EMA and the US-FDA as well as other regulatory agencies, e.g. Japan bringing together pharmaceutical scientists from different parts of the world to review scientific and regulatory issues. The current GBHI Workshop in 2016 aims to continue on the success of preceding workshop featuring 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) and to provide an opportunity to exchange ideas and learn novel/cutting edge science in a focused and “state-of-the-art” meeting

The topics of this Workshop were selected by the Scientific Planning Committee (SPC) with the intention of identifying differences with realistic chances for harmonization based on the scientific state of the art (cf. below). To achieve this objective, the 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. Based on the positive experience with the 1st GBHI Meeting in 2015 in Amsterdam, The Netherlands, the Scientific Committee expects intensive discussions between the regulatory scientists of the involved agencies and the audience. Attendees may expect useful information for advanced designing of BE programs to find acceptance in all regions.

Who Should Attend

The Global Bioequivalence Harmonization Initiative: EUFEPS-AAPS Second International Workshop should be an ideal platform for scientists from the pharmaceutical industry and academia to continue to exchange their experience and views with the regulators and engage in active regulatory discussions

Contact
Padmaja Mummaneni
padmaja.mummaneni@fda.hhs.gov

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