About the event
Arithmos is pleased to present the hosting of the exclusive Roundtable event at MIND Milan on the 9th of April 2024. The event will focus on the challenges in drug safety and latest technology solutions to help the automation and optimisation of pharmacovigilance processes.
Three main topics will be discussed and developed along with the round table guests:
- Advanced Analytics and Reporting
- Connected Data
- Process Automation
The topics will be discussed and developed with the audience in three different workshop groups to facilitate the discussions and sharing of thoughts and ideas. For each topic and group will be assigned a Moderator that will support and chair the workshops.
As guest speaker and representative of industry technology provider, Celine Ghafari, Senior Manager Safety Vault at Veeva System, will co-moderate the event and support the discussion, sharing her expertise and knowledge of Veeva Safety Vault system.
Event Details
Location: MIND Milan Innovation District
Date: 9th April
Time: from 10.00 am to 13.00 am + Networking Lunch
Event Agenda
10.00 am – Welcome Coffee
10.30 am – Opening Session and Introduction to Roundtable Topics
11.00 am – Round Table Workshops
12.30 pm – Groups Findings and Closing Remarks
13.00 pm – Lunch and Networking
Moderators
Gian Nicola Castiglione, Pharmacovigilance Senior Consultant, Lecturer, and former EU QPPV at Chiesi Farmaceutici
Gian Nicola Castiglione has more than 30 years’ experience in the pharmaceutical industry, mostly pharmacovigilance (since 1997). He has experience with European and extra-EU companies and in all functional levels including medical adviser.
Additional skills include clinical development, medical devices vigilance, quality assurance, due diligences, risk management, pharmacovigilance audit and inspections, resources’ management.
Stefania De Santis, Pharmacovigilance Senior Consultant
Stefania De Santis is a qualified EU QPPV and has more than 30 years of experience in the pharmaceutical sector where she has been involved in various departments, but mainly in Pharmacovigilance, throughout her career. Before joining Arithmos as Pharmacovigilance Senior Consultant, she was dedicated to the field of pharmacovigilance as Head of Corporate Drug Safety and qualified Deputy EU QPPV for a major pharmaceutical company since 1992.
Stefania has extensive experience in all pharmacovigilance operations, in both pre-registration and post-marketing settings, case processing, PSUR and DSUR preparation, ICSR/SUSAR management and electronic transmission to the EMA, signal detection and management, safety database validation, safety variations, RMPs development, SDEA/Safety Management Plans and liaising with regulatory authorities.
She is certified by the EMA for the use of Eudravigilance and EXVMPD (Medicinal Product Dictionary).
Raffaele Di Marzo, Head of Pharmacovigilance at Arithmos
Graduated in Medicine and Surgery, Raffaele is a Pharmaceutical physician with more than 30 years of experience. He has acquired, in national and multinational pharmaceutical companies, a robust knowledge of Pharmaceutical Medicine in its different fields of application (Clinical and Epidemiology, Medical Affairs, Pharmacovigilance) as well as supporting the strategic company functions for the maintenance of the business (Regulatory Affairs, Marketing, Market Access and Commercial).
Alessandro Longoni, Senior Consultant Pharmacovigilance Partner at Arithmos
Management consulting professional with 15 years’ experience with extensive knowledge of Life Science trends and needs, Alessandro Longoni manages the development of Digital Transformation in the Life Sciences field with technology solutions and consultancy services for the Italian and International market with focus on Pharmacovigilance domain.
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About Arithmos
We are experts in the Life Sciences industry & Technology.
We are a long-standing Partner and Service Provider across Clinical Development, Regulatory and Compliance, Quality Management, Pharmacovigilance, and Medical Affairs domains.
We help pharmaceutical, biotechnology, nutraceutical, medical device, universities, hospitals and non-profit organisations to gain the best business value through technology-enabled solutions and achieve excellence in business operations.
