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 15-year experience in European regulatory affairs applied to the development, registration and maintenance of both pharmaceutical and biotechnology medicinal products, especially recombinant DNA proteins.
He is actively involved in the design, preparation and management of registration applications, orphan drug designation applications, protocol assistance and scientific advice procedures. In this context he frequently participates in meetings with Regulatory Agencies (both European Medicines Agency and National Agencies).
More recently, David developed a particular interest in the regulatory issues related to the implementation of the Pediatric Regulation in Europe and the preparation of Pediatric Investigation Plans.
Prior to joining Voisin Consulting, he served as Senior Consultant at MDS Pharma Services and worked in the European Regulatory Affairs department of Baxter in France for 5 years. David acquired international experience while working for Eli Lilly in the UK and by doing clinical pharmacy at Roger Williams General Hospital in Providence, USA.
After completing his pharmacy studies at the University of Rennes, France, he earned a post-graduate diploma in International Drug Development and Registration at the University of Paris XI. David is currently a Registered Member of TOPRA.
