Welcome to the Frankfurt Foundation Quality of Medicines

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Every day, medicinal products make a decisive contribution to prevent diseases – especially serious ones – or alleviating ailments, extending the life expectancy of patients and improving their quality of life. In addition to our high expectations of the efficacy and safety of medicines, the pharmaceutical quality of the products is also particularly important with regard to patient care.

The Frankfurt Foundation Quality of Medicines (FFQM) is committed to promoting research activities that are designated to optimally assure the quality of medicinal products in Germany and Europe or, if necessary, further improving them, especially if they are manufactured outside the country. Main concern is the development of advanced processes, the implementation of innovative technologies and their standardization as well as a critical verification of quality assurance concepts.

Download the FFQM flyer here (PDF-File, ~200kB)

Recent news

September 6, 2025 · News

Pearls of Bioequivalence Award 2026 - Call for Submissions

Pearls of Bioequivalence & Biopharmaceutics Award 2026 presented by European Federation Pharmaceutical Scientists (EUFEPS) on initiative and funding by the Frankfurt Foundation Quality of Medicines (FFQM)

The EUFEPS/FFQM Pearls of Bioequivalence & Biopharmaceutics Award is aimed at recognizing outstanding research projects in the fields of biopharmaceutics and bioequivalence as well as the development of innovative delivery systems improving the in-vivo performance of their active ingredients and, thereby, extend the existing treatment options.

This award was originally established by the Frankfurt Foundation Quality of Medicines to support the Global Bioequivalence Harmonization Initiative (GBHI). In the future the prize, endowed with 2,000.00 €, will be awarded every second year jointly by the FFQM and the EUFEPS.

Pharmaceutical scientists are invited to apply for the award by submitting their own applications. Moreover, it is also possible to nominate research projects from other scientists/groups for this award.

Submission Guidelines:

Eligibility: Applications must be based on publications in peer reviewed scientific journal or meaningful summaries of research projects related to bioequivalence, biopharmaceutics or the development of innovative drug delivery systems and should not be older than three years at the time of submission.

Content Requirements: The submissions should demonstrate a significant scientific contribution and show originality and relevance to the field. They should provide insights into methodologies, findings, or applications that contribute in a relevant way to the state of knowledge in bioequivalence and biopharmaceutics.

Submission Format: All entries must be submitted in a clear and concise format and include the following:

Title of the publication or project

Author(s) and their contribution(s) to the project

Synopsis of the research project or copy of the publication

Deadline for Submission: November 30, 2025

Submission Procedure: Applications should be submitted by email to info@frankfurt-foundation.org with the subject line „Pearls of Bioequivalence & Biopharmaceutics Award Submission.“

Evaluation Criteria: Submissions will be evaluated based on the following criteria:

Scientific novelty and significance

Clarity and quality of presentation

Impact on the field of bioequivalence and biopharmaceutics

Award Announcement: The winner will be announced on the websites of the FFQM (https://frankfurt-foundation.org) and EUFEPS (https://eufeps.org). The award will be presented at the EUFEPS Annual Conference 2026 in Naples/Italy (27-29 May 2026).

We look forward to receiving your submission(s) and celebrating the advancements in bioequivalence & biopharmaceutical research.

August 25, 2025 · Prices and Awards

Frankfurt Foundation sponsors first “RMU Award for Pharmaceutical Research & Innovative Medical Therapies”

The Frankfurt Foundation Quality of Medicines is pleased to be able to recognize outstanding scientific concepts with the “RMU Award for Pharmaceutical Research and Innovative Medical Therapies,” thereby helping committed young scientists gain the visibility they deserve.

The Rhine-Main Universities (RMU), the strategic alliance of Goethe University Frankfurt, Johannes Gutenberg University Mainz, and Technical University of Darmstadt, will award this prize, donated by the Frankfurt Foundation, for the first time in 2025.

The award is intended to recognize outstanding scientific achievements and innovative research ideas by postdocs at the RMU. It will be awarded for scientifically sound and creative research ideas. The selection of award winners will focus on the presentation of innovative and forward-looking approaches in research. The aim is to support the transition to the next qualification or career phase and to highlight innovative ideas at an early stage

The nomination deadline is September 30, 2025.

The RMU Award for Pharmaceutical Research & Innovative Medical Therapies is endowed with 10,000 euros. The prize money is to be used at the recipient’s discretion.

 

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August 22, 2025 · Funding Projekts

Thousands of deaths each year due to antibiotic resistance – the FFQM promotes the clinical application of personalized phage therapy

As can currently be read in pharmaceutical journals, for example, according to estimates by the Robert Koch Institute and the Institute for Health Metrics and Evaluation at the University of Washington, resistant pathogens are directly responsible for thousands of deaths. The evaluation refers to the year 2019.

Against the background of the increasing spread of multi-resistant bacterial pathogens, alternative anti-infective therapy approaches such as bacteriophage therapy (phage therapy) are becoming increasingly relevant.

The Frankfurt Foundation Quality of Medicines is therefore pleased to support the PerPhage project, which aims to further develop a quality assurance concept for personalized phage preparations for anti-infective therapy.

Standardized, quality-assured manufacturing processes are required in order to use bacteriophages in a targeted and safe manner. Once these processes have been established, the clinical application of a tailored, safe, and effective complementary phage therapy can be developed for patients in whom antibiotic therapy has failed

The project is led by PD Dr. Silvia Würstle, MBA, Infectious Diseases Section of the II. Medical Clinic at Goethe University Frankfurt Medical Center.

 

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July 12, 2025 · Prices and Awards

Lifetime Achievement Award presented to Professor Amidon.

With this award, the Frankfurt Foundation Quality of Medicines (FFQM) recognizes the extraordinary achievements of Professor Gordon L. Amidon (University of Michigan, Ann Arbor, USA) in the field of pharmaceutical sciences and his outstanding contributions to improving the quality and efficacy of medicinal drugs.

The award ceremony took place during the symposium “Advances in Predictive Biopharmaceutics, Drug Product Quality and Patient Benefit” on July 11, 2025, in Mainz, a joint event organized by Johannes Gutenberg University (JGU) and the FFQM.

In his laudatory speech, Prof. Peter Langguth, pharmaceutical technologist at JGU, highlighted Dr. Gordon Amidon’s scientific contributions, which have improved the understanding of drug absorption and significantly influenced the assessment of the equivalence of generic drugs through in vitro studies. He played a decisive role in the development of the Biopharmaceutical Classification System (BCS) and its regulatory implementation as the BCS-based biowaiver concept.

Professor Langguth, his students, and the FFQM congratulate the award winner on this well-deserved honor.

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July 8, 2025 · News

FFQM commented ICH M13B Draft Guideline

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Together with experts of the EUFEPS (European Federation for Pharmaceutical Sciences) Network on Bioavailability and Biopharmaceutics, the German Pharmaceutical Society (DPhG) and the House of Pharma and Healthcare, Frankfurt, the Frankfurt Foundation Quality of Medicines prepared comments on the draft ICH M13B guideline. These comments and proposed amendments have been submitted to the European Medicines Agency (EMA).

The new guideline regulates options for justifying the waiver of additional bioequivalence studies in the development of medicinal products with multiple strengths. It thus represents a first supplement to the general ICH Bioequivalence Guideline M13A (https://www.ema.europa.eu/en/ich-guideline-m13a-bioequivalence-immediate-release-solid-oral-dosage-forms-scientific-guideline).

The experts recommended clarifications to certain regulations, e.g., the need to conduct in vitro comparative studies using multiple batches and regarding the rounding of mean results. Specific proposals for changes were submitted on the following topics:

  • Ignoring certain excipients (e.g., odorants or flavorings) that are not expected to affect BA/BE when determining a dose-proportional composition of strengths
  • Definition of “high-potency” drug products in the case of fixed-dose combinations
  • Biowaivers in the case of later extensions of a product line with additional dose strengths
  • Comparison of dissolution profiles between dose strengths and verification of their “comparability”
  • Methods for bootstrapping

All comments and proposed amendments submitted to EMA will be published on the EMA website in due course. The revised final guideline is expected to be available in a few months.

May 19, 2025 · Prices and Awards

Alzahra Hamdan received the Hans-Günter Schäfer Science Award 2025

The Hans-Günter Schäfer Science Award 2025 goes to Alzahra Hamdan. She is PhD student in her third year of studies in Pharmacometrics at the Uppsala University/Sweden and was awarded for the publication „Longitudinal Analysis of Natural History Progression of Rare and Ultra-Rare Cerebellar Ataxias Using Item Response Theory”. This paper (Clin. Pharm. Ther., doi:10.1002/cpt.3466) highlights the role of natural history studies and innovative methodologies in enhancing trial-readiness for rare diseases.

This award is sponsored by the Frankfurt Foundation Quality of Medicines (FFQM) and endowed with 1,000 €. Alzahra Hamdan received this award on May 16 at the PKPD expert meeting in Bad Dürkheim/Germany, an annual conference organized by the Arbeitsgemeinschaft für angewandte Humanpharmakologie (AGAH).

The certificate was handed over to the awardee by the AGAH president, Dr. Joachim Höchel (Bayer AG/Berlin), the meeting chair Dr. Nele Müller-Plock (Certara/Berlin) and Prof. Henning Blume, chairman of FFQM’s board.

The Foundation congratulates Alzahra Hamdan for impressive research findings and wishes her continued success in further scientific activities.

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