We organised the Webinar “Signal Detection: how innovation drives efficiency and effectiveness in PV processes”, with the participation of Gian Nicola Castiglione, our Senior Pharmacovigilance Consultant and Filippo Magnaguagno, Senior Consultant, System Integration Services at Arithmos. With special guest speakers Scott Haughie, Senior Director, Statistics Team Lead at Viatris, Ottavio D’Annibali, Head of Centre of Excellence, R&D Global Pharmacovigilance at Chiesi Farmaceutici and Alberto Romanelli, Business Developer Pharma at SAS.
The Webinar was full of insights. We are pleased to share the recording of the Webinar:
About the Webinar
Our new webinar focuses on revolutionising signal detection practices in pharmacovigilance, a crucial process for patient safety and regulation compliance. Traditional methods face challenges due to complex data management and resource-intensive manual processes.
The webinar will showcase how companies like Viatris leverage Bayesian methodologies to address regulatory complexities in signal detection. Chiesi Farmaceutici will present a case study on utilising SAS technology and demonstrate how innovation can improve efficiency and effectiveness. This collaboration between Arithmos and SAS creates an ecosystem that integrates business intelligence, technology and expertise, pushing the boundaries of pharmacovigilance and propelling the industry towards a new generation of safety monitoring and regulatory compliance.
What will you learn during the Webinar?
This webinar provides a comprehensive overview of the benefits of integrating technology into pharmacovigilance operations.
Through a combination of industry expertise and technological innovation, you will gain valuable insights into optimising business operations while fostering a culture of cost efficiency and digitalisation within your organisation.
Why should you join the Webinar?
Join us for an enlightening session that promises to unveil the potential of technology in reshaping the future of pharmacovigilance, empowering organisations to navigate complexities with confidence and drive sustainable growth.
Who is the Webinar for?
QPPVs, Responsible and Specialists of Safety Departments, Medical Directors, and CIOs.
Q&A session
Sign up and leave your question in the dedicated registration form. Our experts will answer you during the Q&A session, at the end of the webinar.
Speakers
Gian Nicola Castiglione, Senior Pharmacovigilance Consultant
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.
Ottavio D’Annibali, Head of Centre of Excellence, R&D Global Pharmacovigilance at Chiesi Farmaceutici
Ottavio D’Annibali is the Head of the Pharmacovigilance Centre of Excellence at Chiesi Farmaceutici, leading a team of professionals in signal and risk management, periodic reporting and medical device vigilance. With a robust background in pharmacovigilance and extensive experience in signal detection and analysis, he drives the translation of company objectives into actionable strategies, with a special focus on study design and evidence generation. My expertise lies in safety signal management, global safety governance committees, RMPs, PSUR/DSUR, ACO/Renewal, labelling updates, and responses to regulatory authorities. Committed to fostering data-driven decision-making, project management, risk communication, and aligning our efforts with the company’s vision.
Scott Haughie, Senior Director, Statistics Team Lead at Viatris
Scott Haughie is currently Statistics Team Lead at Viatris (formerly Mylan) based in the United Kingdom. He has been at Mylan/Viatris for over 12 years and was with Pfizer for 21 years. In that time, Scott has worked as a statistician on many different therapeutic areas and all phases of drug development, and now leads a small global team of statisticians. His interest in signal detection methods arose when the safety group at Viatris needed support in responding to an FDA request, and they reached out to the Statistics group. Scott describes it as a steep, but very rewarding learning curve.
Alberto Romanelli, Business Developer Pharma at SAS
Alberto Romanelli, after graduating in Electronic Engineering with a specialisation in the biomedical field, worked at the French company Umanis as a project manager, handling Business Intelligence projects. He has been with SAS since 2001.
Initially, at SAS, he was in the sales support role for the Finance market until 2012, when he became a Domain Expert for the Commercial market.
Since 2020, he has been focused on promoting SAS technologies for the Pharma market, maintaining constant contact with SAS’s Global Practice Life Science, and bringing both Italian and international value experiences to the attention of clients.
Filippo Magnaguagno, Senior Consultant, System Integration Services at Arithmos
Theoretical Chemist by education from the University of Padova, Filippo spent over 22 years in the Life Sciences sector drifting through and specialising in Computerized Systems from R&D and Analytical to complex Databasing systems devoted to Pharma GxP, both in Analytical and Documental environments.
Senior consultant in complex projects, where Pharmacovigilance software data analysis is required. Ex-ante analysis of both statistical and technical topics to be covered.
Clinical and Omic’s data long-term archiving management for data warehouse implementation consultant in both Pharma and Medical devices areas, with CDISC approach.
About the Webinar: more details
In the ever-evolving pharmacovigilance landscape, the signal detection process remains a critical aspect for ensuring patient safety and regulatory compliance. However, numerous challenges persist, ranging from data management complexities to resource-intensive manual processes.
This webinar delves into these challenges, offering insights into how technology-enhanced solutions can revolutionize signal detection practices.
The complexity of the regulatory environment plays often a major role in identifying challenges related to reporting methodologies in signal detection. On this subject, Viatris will share their experience and resolutions of pain points in signal detection with the introduction of Bayesian Methodologies to their signal detection approach, and how the resolution of regulatory needs could have raised additional questions.
Following, the presentation of a compelling case study from Chiesi Farmaceutici , showcasing the transformative power of leveraging existing technologies to develop customized solutions. By utilising SAS technology as a foundational asset, the development of the Arithmos signal detection solution exemplifies how innovation can drive efficiency and effectiveness in pharmacovigilance processes. Furthermore, webinar attendees will have the opportunity to explore the ecosystem cultivated by Arithmos and SAS Analytics Software, which seamlessly integrates business intelligence, technological advancements, and domain expertise. This collaborative effort not only pushes the boundaries of traditional pharmacovigilance practices but also propels the pharmaceutical industry towards the next generation of safety monitoring and regulatory compliance through the Arithmos + SAS solutions for Pharmacovigilance.
About Arithmos
With deep expertise in the Life Science Industry, Arithmos supports companies in their digital transformation journey to achieve the best value from technology-enabled solutions and excellence in business operations.
Arithmos team share extensive knowledge of the full GxP regulated environment for both deliveries of services and technologies, and our domains range from Clinical R&D, Quality Assurance, Drug Safety & Pharmacovigilance, Regulatory and Medical Affairs.
