Since their first regulatory definition issued on 2010, Post-Authorisation Safety Studies have been confirmed as one of the main tools required by regulatory agencies (EMA) to support the evidence of the drug safety. Discussing the regulatory evolution and the use of observational research methodology in this context, the workshop aims to highlight the key factors that may transform a regulatory need into a successful opportunity to fill significant data gaps.
Speaker: Sara Montanari, MediNeos Quality Assurance Manager
She has competencies in genetics, clinical epidemiology, GCP, Patients Reported Outcomes, computer system validation, pharmacovigilance, quality assurance and quality compliance processes, and in laws and regulations applicable to the conduction of clinical studies.
For more info and registration write to email@example.com
The workshop that will be held in Milan from 2pm to 5.30pm is free and reserved to MediNeos clients