Head of SME Office, European Medicines Agency, EMA
Melanie Carr is currently Head of the SME Office at the European Medicines Agency (EMA).
Melanie is a pharmacist and has been working at the Agency for 14 years. She joined the Pharmacovigilance department of the EMA in 1996 and transferred to the New Chemical Substances Sector of the Agency in 1998 as a Project Manager for Centralised Applications for Marketing Authorisation. In 1999, she became a member of the EMA task force responsible for implementing the EU legislation on Orphan Medicinal Products and setting up the Committee for Orphan Medicinal Products (COMP). Since 2005, she has been responsible for implementing the Agency's SME initiative, setting up and running the EMA's SME Office.
European Medicines Agency - the services and fee reductions available to SMEs ( 220Kb)
In December 2005, the European Medicines Agency (EMA) launched an "SME Office" to provide financial and administrative assistance to micro, small and medium-sized enterprises (SMEs), with the aim of promoting innovation and the development of new human and veterinary medicinal products by SMEs. Incentives available to SMEs, include: administrative and procedural assistance from a dedicated group of personnel within the Agency, fee incentives, organisation of workshops and training sessions for SMEs, and assistance with translation of product information required for the granting of an initial EU marketing authorisation.