Carla Gomes has over 25 years of experience in Regulatory Affairs and currently serves as the Head of the Regulatory Sciences Department at PPD, Thermo Fisher. Her extensive experience spans various sectors, including pharmaceutical companies (Galenic Institute, Iberfar Group, OM Pharma), competent authorities (EMA, INFARMED, Pharmaceutical Society), distribution and logistics (Movianto, Celesio Group), and CRO (PPD, Thermo Fisher). Carla oversees approximately 170 Regulatory Affairs Leaders across 40 countries, providing regulatory strategy and intelligence throughout the entire life cycle of medicines. She is the Regulatory Affairs Oversight Senior Director responsible for the EU CTR implementation at PPD, ensuring cross-departmental communication, updating all SOPs, guidance, tools, and systems, and leading the Liaison team responsible for CTIS submissions.
Carla holds a degree in Pharmaceutical Sciences and a Master’s in Pharmaceutical Technology from the Pharmacy University of Oporto. She earned her MBA from the Catholic University of Oporto and a Master’s in Regulation and Evaluation of Medicines and Health Products from the Pharmacy University of Lisbon. Carla is certified by ELMO on Lifestyle Medicine. Carla is a recognized expert in Regulatory Affairs, a title conferred by the Pharmaceutical Society.