23rd EUFEPS Talks

We want to invite you to the 23rd EUFEPS Talks on June 25, 2025 at 4 pm CEST.

Robert Porszasz will give a talk with the title: "Scientific Decision-Making in Action: The Role of the EMA’s CHMP in a Complex Regulatory Landscape".

Abstract:

The European Medicines Agency (EMA) and its Committee for Medicinal Products for Human Use (CHMP) play a pivotal role in the evaluation and authorisation of human medicines across the European Union. This presentation provides a comprehensive overview of the CHMP’s regulatory activities, with a focus on how scientific evidence, public health imperatives, and evolving therapeutic innovation intersect within the framework of the centralised authorisation procedure.

The CHMP is tasked with delivering robust, science-based opinions on the quality, safety, and efficacy of medicinal products, serving as the cornerstone of the EU-wide benefit-risk assessment. As the demand for timely patient access to novel therapies intensifies — particularly in areas of high unmet medical need such as rare diseases, oncology, and advanced therapy medicinal products (ATMPs) — the Committee must balance scientific rigour with regulatory agility.

This session will explore key procedural and scientific aspects of the centralised marketing authorisation process, including the role of rapporteurs and co-rapporteurs, integrated assessment timelines, and the importance of multidisciplinary scientific dialogue. Special emphasis will be placed on current benefit-risk dilemmas, such as the increasing reliance on surrogate endpoints, limited comparative data, and challenges posed by conditional and exceptional circumstances marketing authorisations.

The discussion will also highlight the CHMP’s strategic focus areas, including the regulatory pathways for orphan medicinal products and ATMPs, where traditional evidence hierarchies are often inadequate, necessitating nuanced assessments and strengthened post-authorisation obligations. The dynamic between regulatory flexibility and scientific robustness will be critically examined, particularly in light of evolving tools such as patient preference studies, real-world evidence, and modelling-based extrapolations.

Finally, the presentation will reflect on recent procedural innovations aimed at enhancing regulatory efficiency and sustainability, including the use of sprint assessments, rolling reviews, and cross-committee collaboration. Through real-world examples and anonymised case reflections, participants will gain insight into the CHMP’s core mission: to ensure that the right treatments reach the right patients at the right time — without compromising the scientific integrity that underpins public trust.

Registration:

A registration is needed for this event. Please use the following link: https://us06web.zoom.us/meeting/register/Rw0UgyMBTDej7A8OlzNsbA. After the registration you will receive an E-Mail with the log-in details.