The object of the day was to outline the national and European regulations and basic legal requirements that affect the development and production of such therapies, as well as their transfer, distribution and use in the public realm. After an introduction by IBEC’s director Josep A. Planell, speakers from the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) and from CIBER-BBN research groups addressed a range of topics and questions including “Will advanced therapies take the place of transplants?” and “The regulatory aspects of research into pluripotent stem cells: legislation and ethics”.
“It was really useful to meet the people from the regulatory bodies,” commented IBEC group leader Ángel Raya, who’s head of the Control of stem cell potency lab. “They can be helpful with setting up clinical trials and advising on protection and commercialisation, so it was good to be able to get to know them face-to-face. I also found out that there are hotlines devoted to helping researchers with the process, which I didn’t realise before.”