TEDDY Participates in 'Innovation in Ethics' Session at ACT EU Multi-stakeholder platform annual meeting
On October 29, 2025, from 09:30 to 17:00 (CET), the Multi-stakeholder platform (MSP) will hold its annual meeting, established as part of the Accelerating Clinical Trials in the European Union (ACT EU) initiative. The meeting, streamed live from the European Medicines Agency (EMA) in Amsterdam, will bring together experts, researchers, policymakers, and patient advocates to discuss the latest innovations reshaping clinical trials in Europe. Please, find the ACT EU Multi-stakeholder platform annual meeting agenda at the following LINK. For more information and for the live broadcast visit the ACT EU Multi-stakeholder platform annual meeting webpage at the following LINK.
Overview of the Sessions: Key Themes
Throughout the day, the meeting will focus on four key themes: patient-oriented research, methodology and biotechnology, AI and digitalisation, and ethics in clinical trials. The goal is to explore how these innovations can align with the European Medicines Agencies Network Strategy (EMANS) 2028 and improve trial outcomes and patient impact. The Session 1: Innovation in patient-oriented research will explore the importance of collecting and utilizing patient experience data, emphasizing the active involvement of patients in trial design to make studies more relevant and centred on their real needs. In the Session 2: The convergence of innovative methodology and evolving biotechnology, Professor Oscar Della Pasqua, Chair of Clinical Pharmacology and Therapeutics at University College London (UCL) and a member of TEDDY Board of Directors, will present concrete examples of clinical trials approved with innovative designs. Session 2 also delving into the challenges and opportunities surrounding Advanced Therapy Medicinal Products (ATMPs) in the current EU landscape. The Session 3: Innovation in AI and digitalisation will examine the potential of digital innovation in healthcare, with a focus on the European Health Data Space and how it could transform patient recruitment for clinical trials. Finally, the Session 4: Innovation in Ethics will address ethical aspects of research, exploring how to ensure participant protection while fostering innovation, with particular attention to informed consent in complex trials.
TEDDY’s contribution in Session 4: Innovation in Ethics
On behalf of TEDDY, Dr. Donato Bonifazi is a permanent member of the ACT EU Multi-stakeholder platform Advisory Group (MSP AG) together with his alternate Dr. Mariagrazia Felisi. Dr. Donato Bonifazi has contributed to the meeting set up as a member of the program committee. Dr. Donato Bonifazi will serve as a panelist in Session 4: Innovation in Ethics to address the challenges of adopting AI and eConsent/eAssent in clinical trials, focusing on the gap between innovation and existing legal/ethical regulations, while exploring potential solutions, strategies, and benefits within a continuously evolving context. Donato will share TEDDY’s experience in creating age-appropriate, easily understandable consent/assent forms and informative materials, ensuring that paediatric patients fully understand their rights and the impact of the trial.