About me
Ana is a Senior Scientific Specialist who works as a Product Lead in the Oncology and Haematology Office at EMA. Responsible for clinical and regulatory science input for a portfolio of products from pre-submission of initial marketing authorisation through post-authorisation. Further to this, she worked on the implementation of the IVDR and is currently one of the main points of reference for regulatory guidance on companion diagnostics at the Agency. Previously 2003-2014 Ana worked as Product Team Leader in the area of Quality of Medicines at EMA. Prior to joining the Agency, Ana was a pharmaceutical assessor in the Chemical and Pharmaceutical Technology Division at the AEMPs. Ana has over 20 y. of experience within the Pharma. framework.