Avril Mankel

Company: Santen GmbH

Dr. Avril Mankel has a PhD in Cell and Developmental Biology and is currently working at Santen GmbH. She was Senior Manager Regulatory Affairs at NDA Regulatory Service GmbH in Munich, Germany. After having worked for several years as post-doc at the University of Würzburg, the University Hospital and the Max-Planck-Institute for Molecular Genetics in Berlin she has been working for 14-years in the pharmaceutical industry now. She is an expert in the area of regulatory strategic advice for the development of medicinal products in Europe, submission and follow-up of MAA, full management for Scientific Advice and Protocol Assistance procedures, preparation of and advice on Briefing Books including questions and company positions for Scientific Advice and Protocol Assistance procedures, full management of Paediatric Investigation Plans (PIP) / Waiver / Deferral applications at EMA, preparation of documents required for the application of Paediatric Investigation Plans (PIP) / Waivers / Deferrals, preparation of documents for the application for Orphan Designations, preparation of documents for re-examination procedures after negative CHMP opinions, maintenance of approved licenses (follow-up measures, renewals, variations, implementation of regulations as required by EMA and national Agencies), preparation of IMPDs and IBs for Clinical Trial Applications. She acted as representative for companies at meetings with EMA and national agencies.