With the exponential growth in biotechnology product development, it follows that there is a corresponding increase in biotech clinical trial experience. However, despite this increase in experience, biotech clinical development continues to be a challenging exercise, particularly anticipating the regulatory requirements for gaining approval to conduct a trial and later the clinical requirements for marketing approval.
Stuart Mudge, Emmanuelle Voisin
2003 - Applied Clinical trials
Biotech Clinical Development in European Union : Anticipating the regulatory hurdles
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.
Stuart Mudge, Senior Consultant Product Development
Stuart's focus was providing regulatory and project management services to a range of clients, typically emerging life science companies seeking to develop their products in the European and USA markets. At all times the goal was to deliver and implement development plans that were compatible with both Europe and the USA.