PQRI/EUFEPS Global Bioequivalence Harmonisation Initiative (GBHI): 7th International Workshop – GBHI 2027

April 27 - 29 • 2027 • Lisbon, Portugal

www.eufeps.org  www.pqri.org  https://www.fda.gov/ 

Dear Colleagues,

The 7th Global Bioequivalence Harmonization Initiative Conference (GBHI 2027) will be held on April 27–29, 2027, in Lisbon, Portugal.

We are pleased to announce that Product Quality Research Institute (PQRI), the U.S. Food and Drug Administration (FDA), the European Federation for Pharmaceutical Sciences (EUFEPS), and the University of Lisbon will bring together international experts for the 7th GBHI Conference.

The Global Bioequivalence Harmonisation Initiative (GBHI) aims to support the process of global harmonization through scientific discussion and exchange among international stakeholders. Since the first GBHI Conference in 2015, the meetings have provided a forum for scientists from regulatory agencies, academia, and industry to exchange scientific perspectives, discuss current challenges in bioequivalence, and explore opportunities for greater international alignment. The interactive format enables pharmaceutical scientists to share their experience and data with regulatory experts and to engage in constructive scientific discussions on issues relevant to the development and assessment of bioequivalent medicines.

The 7th GBHI Conference will continue this tradition by bringing together leading experts from regulatory agencies, academia, and the pharmaceutical industry. The program will address current and emerging topics in bioequivalence, including ICH M13A, B, and C for solid oral immediate-release products; Model-Informed Drug Development (MIDD); bioequivalence of topical drug products; and bioequivalence for orally inhaled and nasal drug products (OIDPs). TEST - 6th International Worksh… TEST - 6th International Worksh…

The GBHI conference series has also generated published scientific reports documenting the discussions and conclusions of previous meetings. The report of the 6th GBHI Conference, held in 2024, was published in the European Journal of Pharmaceutical Sciences in 2025. ScienceDirect

We warmly welcome you to Lisbon for the 7th GBHI Conference and look forward to an engaging exchange of scientific and regulatory perspectives in support of global bioequivalence harmonization.

We look forward to welcoming you to the 7th GBHI Conference!

Session topics

A draft Program will be available in Fall 2026.

The topics at the 2027 GBHI will include the following:

• ICH M13A, B, and C
  
  • Solid oral immediate release products; industry and agency experience with M13A/B and
    progress on M13C.
• Model-Informed Drug Development (MIDD)
  
  • Modelling approaches for special populations, long-acting injectables, ophthalmologic
    products, and others.
• Bioequivalence of Topical Drug Products
  
  • Alternative PK-based methods, in vitro release testing (IVRT), and in vivo permeation
    testing (IVPT).
• Bioequivalence for OIDPs
  
  • Orally inhaled & nasal drug products; harmonization of EMA and FDA approaches,
    including in vitro impactor data and waiver options.