Cell therapy consists of the prevention or treatment of human diseases by the administration of viable cells which have been selected, cultured, often multiplied, and possibly pharmacologically treated or altered outside the body (ex-vivo). This article will present the wide array of different approaches present today in Europe for the regulation of cell therapy products and envision how cell therapy products could be regulated in the near future.
2003 - DIA
Cell Therapy - Current Regulatory Framework, Forum article for April 2003
Emmanuelle M. Voisin, Founder and CEO
Emmanuelle Voisin founded Voisin Consulting Life Sciences (VCLS) in 1997. The firm has become a leading advisor to Biotech, Pharma and Medtech manufacturers for the development, registration and launch of innovative medical technologies across international markets. Emmanuelle Voisin has 30 years’ experience in drug development. Her expertise lies in non-conventional development strategies, maximizing the use of regulatory mechanisms and innovative approaches to drug development, to bring innovative technologies to patients.