Lorenzo Montrasio | Independent Advisor
European commission
Since 2024, Lorenzo has worked as an independent advisor, collaborating with national governments and international organizations to promote partnerships for medicine development and strengthen regulatory systems. Previously, he led the work on access to innovative treatments and technologies at the Council of Europe (2020-2023) and supported the development of international healthcare collaborations at the European Pharmacopeia (2018-2020). At the Italian Medicines Agency (AIFA), he was Head of the Biological Medicines Office (2011-2018) and Senior GMP inspector (2003-2010). Lorenzo studied Pharmacy (1990-1995), Clinical Pharmacy (1998-2001), and Regulatory Affairs (2001-2005). During his career, he has been chair and member of working groups and steering committees at EMA, WHO and the EC. He has collaborated with universities, NGOs, and professional and patient organizations to facilitate dialogue and support transformative projects for a more equitable access to health care.
Appearances:
Festival of Biologics Day 1 @ 12:30
Protecting healthy volunteers in clinical trial - The VolREthics initiative.
Healthy volunteers play a vital role in advancing science and medicine through their participation in research studies. Their contribution is especially well recognized in the early stages of medicinal product development and pharmacokinetic studies. However, their motivations, the risks they face, and the ethical issues involved can vary significantly depending on the context. The Global Charter developed by the VOLRETHICS initiative seeks to strengthen the protection of healthy volunteers, particularly in relation to the risks of harm, exploitation, and compromised well-being.
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