Dr Detela is a customer-focused, global Regulatory Affairs Lead within PPD Regulatory Science. Her experience in regulatory management of multinational clinical trials covers start-up, maintenance and end stages for phase I, II and III clinical trials across Europe, Canada, Asia-Pacific and Latin America. Dr Detela supports Clients developing cell and gene therapy products to interact with EU national Competent Authorities, the European Medicines Agency and with EU pre-authorisation procedures. Dr Detela holds a BSc in Biological Sciences, a MSc in Functional Genomics from the University of Trieste, Italy and a PhD in Biochemical Engineering from University College London in the United Kingdom.
The implementation of the Clinical Trial Information System (CTIS), from 31 January 2022, will facilitate the day-to-day business of sponsors of clinical trials by harmonising submission and maintenance of trial applications, assessment and supervision of trials, while promoting patient safety and transparency…