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
Registration is now open. Click here to register.
Dear Colleagues,
The 6th International Workshop – GBHI 2024 will be held on April 16-17, 2024, in Rockville, Maryland, US, hosted by USP.
We are pleased to announce Product Quality Research Institute (PQRI) is joining 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 will be held in the US in 2024. Global regulatory, academia and industrial speakers will be 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
We welcome you to attend the 6th GBHI Workshop!
Workshop Details
DATES:
April 16-17, 2024
LOCATION:
Hosted by USP at USP Meetings Center **
12601 Twinbrook Pkwy, Rockville, MD 20852
HOTEL ACCOMMODATIONS:
A Room block has been arranged at the Hilton Washington DC/Rockville Hotel & Meeting Center (1750 Rockville Pike, Rockville, MD). Use this reservation link to book your hotel to get the room block rate ($209 + taxes). Be sure to book your hotel room before March 25, 2024.
** The meeting location has convenient access by public transportation to Washington, DC with its well-known monuments and sights, world-famous Smithsonian museums (including art, history, science, Air and Space and the National Zoo all offering free admission), theaters, sports venues, and Michelin-rated restaurants. Washington, DC is a must-see place to visit.
Registration
Registration is open. Click here to register.
Registration Fees
Workshop Registration Category | After March 1, 2024 | |||
---|---|---|---|---|
General
|
$1,500.00 | |||
Government/Regulatory Authorities/Academic Attendees
|
$450.00 | |||
FDA Speaker (1 Day)
|
$225.00 | |||
Speaker/Moderator (including FDA Speaker – 2 Day)
|
$0.00 |
Workshop Topics
The topics at GBHI 2024 may include but are not limited to the following:
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- Session 1: Moving the Needle Towards Convergence on ICH M13 Topics
- Part 1: Oral PBPK
- Part 2: Narrow Therapeutic Index (NTI) Drugs and Highly Variable Drugs (HVDs)
- Session 2: Bioequivalence Considerations for Modified Release (MR) Drug Products: Single Dose vs Multiple Dose Studies and Strength Waivers
- Part 1: Single Dose vs Multiple Dose for BE demonstration of MR products
- Studies needed for BE demonstration of additional strengths in solid oral MR products
- Session 3: Partial AUC (pAUC) for Bioequivalence Demonstration
- Part 1: Regulatory Overview
- Part 2: Academic Overview
- Part 3: Industry Viewpoint
- Bioequivalence Study Consideration for orally inhaled drug products (OIDPs)
- Part 1: Regulatory Session
- Part 2: Scientific Session
- Session 1: Moving the Needle Towards Convergence on ICH M13 Topics
Networking Reception
PQRI will host 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. See address and information above.
Pearls of Bioequivalence Award
At the networking reception, The Frankfurt Foundation Quality of Medicines and the EUFEPS Network Bioavailability and Biopharmaceutics will present the 2024 Pearls of Bioequivalence Award. This award recognizes senior scientists, who contribute significantly to the development of advanced concepts for bioequivalence assessment.
Workshop Materials
The draft program is available to download here. (As of 3/21/24)
Workshop Logistics are available here.
A GBHI 2024 flyer is available to download and share with your interested colleagues.
Another FDA/PQRI Workshop of Interest
PQRI and FDA are organizing the FDA/PQRI Workshop: Challenges and Opportunities for Modified Release (MR) Oral Drug Product Development – A Forum for Stakeholder Engagement to be held on Thursday, April 18, 2024 following GBHI 2024. This FDA/PQRI workshop (also to be held at USP) will further explore discussions on MR products that will not be covered at GBHI 2024. Visit the Workshop webpage for more details. (NOTE: Separate registration is required for each event.)
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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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