WORKSHOP 19

European Medicines Agency

Naam: Sonia Ribeiro

Loopbaan: Sonia Ribeiro started her career as a pharmacist at the Portuguese Medicines Competent Authority, INFARMED in 2000 where she was project manager for new applications for marketing authorisation via the national and mutual recognition procedure. She was also in charge of following and implementing the Commission Decisions further to referral procedures. Sonia Ribeiro was also the INFARMED representative at the Quality Review of Documents Group and at the Name Review Group at the EMEA (between November 2003 and April 2004).

In April 2004, she came to the Agency as a National Expert to support the Mutual Recognition Facilitation Group (MRFG), formalised in November 2005 in the CMD(h), for which she was responsible until July 2009. Then she moved to Regulatory Affairs and worked as Regulatory Affairs Adviser where she provided regulatory and procedural advice in relation to the development, evaluation and surveillance of medicinal products submitted through the centralised procedure. In addition, she was responsible for supporting the implementation of the Variations Regulation and participated regularly in the CMD(h) Sub-group on Variation Regulation.

Since July 2014, Sonia is working as Head of Regulatory Affairs Office in the Human Medicines Evaluation Division of the European Medicines Agency

Beroep: Head of Regulatory Affairs Office in the Human Medicines Evaluation Division of the European Medicines Agency