Accelerating development, registration and access to medicines for rare diseases in the European Union through adaptive approaches: features and perspectives
There is growing recognition that the current research-and-development (R&D) and innovation-regulation ecosystem could be made more efficient to stimulate and support access to innovative therapies for those patients with rare, life-threatening diseases for which there are no adequate licensed therapies.
Emmanuelle Voisin, David Uguen
2014 - Orphanet Journal of Rare Diseases
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.
David Uguen, Executive Director Drugs and Biologics
David Uguen is responsible for the management of projects involving the design and implementation of regulatory strategies for the development of drugs and biologics. David gained a 18-year experience in European regulatory affairs applied to the development, registration and maintenance of both pharmaceutical and biotechnology medicinal products.