Isabel Chicharo

Head of Regulatory Data Management Service at EMA

Speaker

I am responsible for the operational management of Regulatory Master Data Management Services, currently on Substances, Products, Organisations and Referential data (also known as SPOR) as well as xEVMPD/Art 57 data. I also coordinate the activities around implementation of ISO IDMP in EU.

I have a Pharmacy Masters degree, a post graduate degree in Pharmaceutical regulation and over 20 years of data management experience in the field of Medicines.

My past experience covers clinical pharmacy in a Hospital, a Software company producing medical dictionaries for Pharmacies and the Portuguese authority (INFARMED). Since 2008 I have worked for EMA where I have been involved in or coordinated many projects ( e.g. EUTCT, ECD, SIAMED II implementation, Data Integration/SPOR...). In addition to data management, I have also been responsible for areas such as standards and enterprise content management.