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. Some example from MediNeos expirience in conducting these type of studies.
Speaker: Christian Amici, MediNeos Clinical Project Portfolio Manager
After graduating in Pharmaceutical Biotechnology, he obtained a master’s degree in International Health Care Management, Economics and Policy at Bocconi University (Milan). He began his work experience in MediNeos in 2009 as Clinical Research Associate and later as a Study Designer. Since 2014 he has covered the role of Clinical Project Portfolio. Christian has a consolidated experience in: observational research, international and local project management and account, public speech and epidemiology
The webinar is free and reserved to MediNeos clients