Carla Gomes has been working in Regulatory Affairs for more than 20 years and presently, is the Head of the Regulatory Sciences Department at PPD, Thermo Fisher; her experience includes Pharmaceutical Companies (Galenic Institute, Iberfar Group, OM Pharma), Competent Authorities (EMA, INFARMED, Pharmaceutical Society), Distribution and Logistics (Movianto, Celesio Group) and CRO (PPD). Carla Gomes oversees about 150 Regulatory Affairs Leaders across 40 countries, who provide Regulatory strategy and intelligence over the whole life cycle of the medicine, handling several complex studies. Carla Gomes is the Regulatory Affairs Oversight Senior Director responsible for the EU CTR implementation at PPD, assuring cross departmental communication, determining that all SOPs, guidance’s, tools and systems are updated, and being responsible for the Liaison team (team responsible for the CTIS submissions).
Carla Gomes holds a graduation in Pharmaceutical Sciences and has a Master in Pharmaceutical Technology by the Pharmacy University of Oporto, earned her MBA by the Catholic University, Economics, of Oporto and has a Master in Regulation and Evaluation of Medicines and Health Products, by the Pharmacy University of Lisbon. Carla is expert in Regulatory Affairs, title provided by the Pharmaceutical Society.