CHANGE IN REGULATORY SCIENCES IN THE EU – HOW TO MOVE FROM A REACTIVE TO A MULTI-STAKEHOLDERS PROACTIVE ATTITUDE
25 – 27 October, 2018
Istituti Clinici Scientifici Maugeri – Pavia (Italy)
The XI Foresight Training Course was organized by the Fondazione per la Ricerca Farmacologica Gianni Benzi and the Master in Regulatory Science “Gianni Benzi” at the University of Pavia, in collaboration with Istituti Clinici Scientifici Maugeri and SIAR, the course addressed the evolving landscape of regulatory science in Europe.
Over three days, key opinion leaders and experts from across Europe examined how to better align scientific innovation and patient needs with evolving regulatory frameworks throughout the development of health products. The program focused on three key themes:
- Medical Devices: The course opened with discussions on the implications of the EU Regulations 2017/745 and 2017/746 on medical and in vitro diagnostic devices. These regulations, directly applicable across member states, aim to enhance legal clarity and patient safety through a more robust and harmonized legislative framework.
- Health Data and GDPR: The second day explored the role of health data in supporting innovation in medicines and healthcare. Emphasis was placed on the opportunities and responsibilities arising from increased digitalization, particularly under the General Data Protection Regulation (GDPR), which significantly influences data quality, sharing practices, and ethical standards in clinical research.
- Orphan Medicines and Rare Diseases: The final session highlighted the progress and remaining challenges under the Orphan Medicinal Products Regulation. While the regulation has led to significant advancements, many rare diseases still lack treatments. An upcoming revision of Regulation (EC) 141/2000 is anticipated to enhance research incentives and harmonize evaluation procedures across the EU.
The event served as a vital platform for dialogue among companies, regulators, academics, patients, and students, fostering collaboration and proactive engagement to support the development and timely availability of health products in the EU.
Download the agenda of the course.
The news related to the XI Foresight Training Course “Change in Regulatory Sciences in the EU – How to move from a reactive to a multi-stakeholders proactive attitude”, held last October 25-27 in Pavia appeared on the following media:
Pazienti, scienziati e regolatori: come cambia il paradigma delle scienze regolatorie in Europa
Pazienti, scienziati e regolatori: come cambia il paradigma delle scienze regolatorie in Europa
