Ana Zanoletty

Ana Zanoletty has a diploma in Dietetics and Human Nutrition, followed by a BSc in Pharmacy. She worked in the area of clinical trials in Spain for seven years, and subsequently moved to London to join the EMA in 2006 where she spent her initial years coordinating the initial marketing authorisation procedures for endocrinology and pulmonary arterial hypertension products. At that time she also got heavily involved in the field of electronic submissions at EMA.  Ana later transitioned into the management of post-authorisation procedures, covering all types of procedures, with a particular focus on the periodic safety update reports (PSUR). Ana was one of the main contributors to the development of the PSUR single assessment (PSUSA) procedure in the EU, and key subject matter expert for the development and implementation of the PSUR Repository, a centralised repository of PSUR submissions and assessments.

In 2017 Ana joined the labelling office at EMA, wanting to specialise further in all aspects related to the quality of the product information and labelling. She is the process owner of the EMA Name Review Group (NRG), managing the coordination and daily running of the NRG, in collaboration with naming experts across the EU. She has led important naming activities in the EU such change of name of liposomal medicines at high risk of medication errors, and is currently engaged in the naming aspects of COVID-19 variants. Ana also works with the Quality Review of Documents (QRD) group, and is specialised in the product information of advanced therapy medicinal products where she actively collaborates with the Committee of Advanced Therapies and the European Commission in the development of product information templates for this specialised field.

Ana now lives in Amsterdam, and learns Dutch in her spare time.