Arna Hrund Arnardóttir

Arna is a pharmacist by training who in 2013 defended her thesis on benefit-risk assessment of pharmaceuticals, including post marketing safety and different views of stakeholders regarding acceptance of new drugs to the market. Before she started her PhD, she had been working in the RA department of an Icelandic pharmaceutical company. Arna has experience with the overall European CTD dossier, having written and maintained sections from Modules 1 through 5, building on her knowledge in CMC, RA and clinical requirements. Arna joined DADA in 2012 and, as a Senior Consultant, has been responsible for developing DADA’s Pharmaceutical Safety and Efficacy services. She has an expertise in Good Clinical Practice and is qualified to perform GCP audits. Arna is DADA’s subject matter expert on clinical strategy and pre-submission regulatory dialogue. She has assisted DADA clients with Scientific Advice applications, Paediatric Investigation Plan submissions, Orphan Designation requests and multiple other aspects of the Pharmaceutical Safety and Efficacy services.