PQRI/EUFEPS Global Bioequivalence Harmonisation Initiative (GBHI): 6th International Workshop – GBHI 2024
An In-Person Event; April 16-17, 2024 • Rockville, Maryland, US
www.pqri.org • www.eufeps.org • www.fda.gov
Dear Colleagues,
The 6th International Workshop – GBHI 2024 was held on April 16-17, 2024, in Rockville, Maryland, US, hosted by USP.
Product Quality Research Institute (PQRI) joined the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) and the European Federation for Pharmaceutical Sciences (EUFEPS) in co-sponsoring the “6th International Workshop on Global Bioequivalence Harmonization Initiative”.
The Global Bioequivalence Harmonisation Initiative (GBHI) is intended to support the process of global harmonization via scientific discussion among international stakeholders. The first GBHI Conference, held in March 2015, and all subsequent conferences have been successful due to the active participation and presentation by speakers and participants from global academia, industry, and regulatory agencies. The GBHI workshop should be an ideal platform for scientists from the pharmaceutical industry and academia to exchange their experiences and views with the regulators and engage in active scientific discussions. The GBHI Workshop location alternates between Amsterdam, the Netherlands, and the US. The 6th GBHI Workshop was held in the US in 2024. Global regulatory, academia and industrial speakers were invited to the discussions.
The conference report of the last GBHI conference in Amsterdam 2022 was recently published at the European Journal of Pharmaceutical Sciences (Eur J Pharm Sci) in November 2023. Click to download the article: DOWNLOAD
The GBHI 2024 Organizing Committee will prepare a conference report, which we will post on this site when it is available.
Networking Reception
PQRI hosted a Networking Reception on Tuesday, April 17, 2024 at 5:30 – 7:00 PM at the Hilton Washington DC/Rockville Hotel and Executive Meeting Center.
Pearls of Bioequivalence Award
At the networking reception, The Frankfurt Foundation Quality of Medicines and the EUFEPS Network Bioavailability and Biopharmaceutics presented the 2024 Pearls of Bioequivalence Award to Dr. James Polli, University of Maryland. This award recognizes senior scientists, who contribute significantly to the development of advanced concepts for bioequivalence assessment.
Workshop Materials
The final program is available to download here. (As of 4/10/24)
Workshop Logistics are available here.
The Workshop speaker/moderator/panelist bios are available here.
Another FDA/PQRI Workshop of Interest
PQRI and FDA organized the FDA/PQRI Workshop: Challenges and Opportunities for Modified Release (MR) Oral Drug Product Development – A Forum for Stakeholder Engagement held on Thursday, April 18, 2024 following GBHI 2024. This FDA/PQRI workshop (also to be held at USP) further explored discussions on MR products that were not covered at GBHI 2024. Visit the Workshop webpage for more details.
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Workshop Planning Committee:
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- Wenlei Jiang, PhD, Food and Drug Administration (FDA), US (co-chair)
- Barbara S. Schug, PhD, SocraTec R&D GmbH, Germany (co-chair)
- Susana Almeida, PhD, Medicines for Europe, AISBL, Belgium
- Gerald Beuerle, PhD, Teva, Germany
- Erem Bilensoy, PhD, Hacettepe University, Turkey
- David Brown, PhD, Medicines and Healthcare products Regulatory Agency, UK
- Jack Cook, PhD, A2-Ai, US
- Eduardo Agostinho Freitas Fernandes, MSc, Agência Nacional de Vigilância Sanitária (ANVISA), Brazil
- John Gordon, PhD, Health Canada, Canada
- Sebastian Haertter, PhD, Boehringer Ingelheim, Germany
- Georg Hempel, PhD, University of Münster, Germany
- Evangelos Kotzagiorgis, PhD, European Medicines Agency (EMA), Netherlands
- Ryosuke Kuribayashi, PhD, Pharmaceuticals and Medical Devices Agency, Japan
- Mehul Mehta, PhD, Food and Drug Administration (FDA), US
- Andreas Kovar, PhD, Sanofi, Germany
- Katalina Mettke, PhD, Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Germany
- Paulo Paixão, PhD, Lisbon University, Member of the Medicines Evaluation Board at INFARMED, Portugal
- Anne Seidlitz, PhD, Heinrich Heine University Düsseldorf
- Nilufer Tampal, PhD, Food and Drug Administration (FDA), US
- Yu-Chung Tsang, PhD, Apotex, Canada
- Ralph-Steven Wedemeyer, PhD, SocraMetrics GmbH, Germany
- Jan Welink, PhD, Medicines Evaluation Board (MEB), Netherlands
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