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Fourth International Workshop on
Global Bioequivalence Harmonization Initiative (GBHI)

FDA/AAPS/EUFEPS CO-SPONSORSHIP AGREEMENT

Co-sponsored by the:
U.S. Food and Drug Administration (FDA) and
American Association of Pharmaceutical Scientists (AAPS) and European Federation for Pharmaceutical Sciences (EUFEPS)

 

 

Date:                    December 12-13, 2019

Location:
DoubleTree Bethesda
8120 Wisconsin Ave
Bethesda, MD, 20814

Background:

As  stated above, FDA is co-sponsoring with the American Association of Pharmaceutical Scientists (AAPS) and the European Federation for Pharmaceutical Sciences (EUFEPS) ‘Fourth International Workshop on Global Bioequivalence Harmonization Initiative’ that will deliver cutting edge science in a focused and “state-of-the-art” meeting. Key areas of focus will include:

• Fasted and fed bioequivalence requirements for immediate release products
• Evaluation of bioequivalence of long acting injectables and implants
• Bioequivalence assessment of orally inhaled products

Global Bioequivalence Harmonization Initiative (GBHI) was begun as the initiative of EUFEPS, the European Medicines Agency (EMA), and the US Food and Drug Administration (FDA).

EUFEPS together with the American Association of Pharmaceutical Scientists (AAPS) has started to organize international conferences on bioequivalence and to highlight its importance in making affordable high quality essential medicines available globally.The first conference took place in 2015 in Amsterdam/ The Netherlands, and the next one was in 2016 in Rockville/ the USA. The third one was held in Amsterdam, The Netherlands, from April 12-13, 2018 and the next upcoming international workshop with cosponsors (FDA-AAPS-EUFEPS) is to be held in Washington DC, December 2019.

Goals and Objectives

The goal of the Global Bioequivalence Harmonization Initiative (GBHI) conference is to offer the most informative and up to date science and regulation of bioequivalence in global drug development. GBHI workshop provides an open forum for pharmaceutical scientists from academia, industry and regulatory agencies to discuss various bioequivalence topics  of interest, for example,
(a) fed bioequivalence for immediate release products
(b) bioequivalence of long acting injectables and implants,
(c)bioequivalence of orally inhaled products, and
(d) possibility of international reference product

The presentations and discussions of these issues potentially enhance the mutual understanding of scientific background for bioequivalence evaluation and further facilitate harmonization of regulatory approaches for establishing bioequivalence of multisource drug products.  By the end of the program, the attendee will develop an appreciation and in-depth understanding of the on-going scientific and regulatory efforts to improve the quality of pharmaceutical products and their impact on pharmaceutical care.

The topics of this Workshop were selected by the Scientific Planning Committee (SPC) from FDA, AAPS and EUFEPS with the intention of providing a forum for open discussion, identifying differences with realistic chances for harmonization based on the scientific state of the art, and accelerating drug development by obtaining input from multi stake holder perspective.

Who Should Attend

This conference is intended for leaders in Academia, the Pharmaceutical and Biotechnology Industry (PhRMA, BIO, GPhA), contract research organizations, API manufacturers, and domestic and international regulatory agencies in positions to affect the science and regulation of drug discovery and development, who wish to stay abreast of the national and international initiatives affecting the development of safe and effective pharmaceutical drug products.

Contact:

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

For registration details contact AAPS at
AAPS/EUFEPS Global Bioequivalence Harmonization Initiative: 4th International Workshop