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.
Speaker: Stefano Viaggi, MediNeos Director of Marketing and Real World Data Solutions
With a special talent for innovation and strategic thinking, he has been working in the pharmaceutical sector for over 25 years, providing statistical/epidemiological consultancy and project design for multinational pharmaceutical companies, Clinical Research Organizations and CME providers. He holds a university degree in Statistics, is co-author of several clinical research and epidemiological papers and has a special interests in forecasting and collective intelligence.
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