EURORDIS response to European Ombudsman strategic inquiry into pre-submission activities organised by the European Medicines Agency

Comments Ombudsman Inquiry on EMA pre-submission activitiesThe European Ombudsman has requested the opinion of interested parties on how the European Medicines Agency conducts pre-authorisation activities on medicines. This document is the EURORDIS response to that inquiry, setting out why the current system is robust and vital to ensure that clinical development is well designed and with input of patients.

(January 2019)

The voice of rare disease patients in EuropeEURORDIS The international voice of people living with rare diseasesRare Disease International Bringing together patients, families and experts to share experiences in a moderated multi-language forum. RareConnect The Rare Barometer Programme is a EURORDIS initiative that carries out surveys to transform rare disease patients' experiences into figures and facts that can be shared with decision-makers.Rare Barometer An international awareness raising campaign taking place on the last day of February each year, Rare Disease Day is a EURORDIS initiativeRare Disease Day Join the largest gathering of rare disease stakeholders across Europe, at the biennial European Conference on Rare Diseases and Orphan Products. ECRD is a EURORDIS initiativeEuropean Conference on Rare Diseases