On the 30th of November, we conducted the webinar “Key Success Factors for Setting Up an Effective Pharmacovigilance System”, with Stefania De Santis, Director of Pharmacovigilance of seQure, the business unit of Arithmos.
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About the Webinar
According to the WHO, Pharmacovigilance is the science and activities relating to detecting, assessing, understanding, and preventing adverse effects or any other possible drug-related problems.
The main responsibilities of Pharmacovigilance are the collection of safety data and information on “special situations”, their medical assessment, and the detection of new signals of risk: these tasks are all aimed to know the risks possibly related to the Marketing Authorisation Holder’s medicinal products and to manage such risks with the aim to minimise them.
The number and complexity of the activities involved in the above processes require a comprehensive strategic planning, design and execution phases to fulfil in order to achieve a robust PV system and process.
During the webinar, we explored the key success factors and critical activities that enable setting up and maintaining an effective PV system, in accordance with the quality standards that are detailed in Good Pharmacovigilance Practices.
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What will you learn watching the webinar?
You will get insight into the minimum requirements and how to overcome the challenges for setting up and maintaining an effective Pharmacovigilance system.
Language
English
Speaker
Stefania De Santis
Director of Pharmacovigilance of seQure, a business unit of Arithmos
Stefania De Santis is a qualified EU QPPV and is seQure’s Director of Pharmacovigilance; as such she is responsible for strategic planning and workflow development as well as guaranteeing the quality of our pharmacovigilance services.
Stefania 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 seQure, 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).
Stefania De Santis on Linkedin
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About Arithmos
We are Business and Technology experts in the Life Science industry.
We help pharmaceutical, biotechnology, nutraceutical, medical device, universities, hospitals and non-profit organisations to gain the best business value through technology-enabled solutions. With our business units seQure and The CQA Company, we provide Quality Compliance and Consulting services.
We deliver solutions and services for:
- Pharmacovigilance and Safety
- Regulated Document Management
- Reporting & Analytics
- eClinical
- Quality Management
- Computer System Validation
- Regulatory Affairs
- Cloud Services
- IT Services
Our industry-leading experts combine the knowledge of processes and technologies to implement your digital strategy, enable rapidly scale-up along with fulfilling oversight, governance, and compliance requirements.
We support your:
- Digital Transformation
- Business Process Re-engineering
- System Integration
- Data-Driven Management
