Innovative therapies pose special problems for drug developers and regulators alike. By definition, such therapies tend to leap forward into unregulated or incompletely regulated territory. Orphan drugs often fall into the category of “innovative therapies” and certainly stretch and challenge established regulatory guidelines.
2002 - DIA
Progress in the development of Regulations for Orphan Drugs in Europe, Forum article for December 2002
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.