Dr. Yvonne Nanciu
Bayer
PV Country Head, Graduated Plan Officer Germany, Deputy EU QPPV
Patient-centric Pharmacovigilance - making it a reality
- Patient centricity continues to be a buzzword, but what is the reality?
- What can we do to promote a patient-centric approach in Pharmacovigilance
- Practical examples
- Challenges
- Future opportunities
Giovanni Furlan
Pfizer
Worldwide Safety Site Lead, Director
The Importance of Pharmacogenomics in Pharmacovigilance
- Genetic factors account for 15% to 95% of inter-individual differences in drug metabolism and response.
- The extent to which a single gene contributes to an adverse reaction depends upon how many other genes affect the biological pathways that are involved in the adverse reaction.
- Genetic testing can be used to identify patients at risk of experiencing a certain reaction.
- Clinical utility should be the guiding principle to decide when to require genetic testing prior to taking a drug.
Dr. Dnyaneshwar Sanap
Glenmark Arzneimittel GmbH
EU/UK QPPV, Head regional pharmacovigilance
Signal Management in Pharmacovigilance: Unveiling Drug Risks Together
- Signal detection sources and methodologies qualitative vs quantitative SD
- SD in special situations
- GvP signal management process
- Signal communication
- What Auditors/inspectors are looking at?
Gurpreet Singh
IQVIA
Vice President, Managing Director Integrated Safety
Pharmacovigilance – Trends, Challenges and Opportunities
- Safety Databases
- Electronic Health Records (EHRs) & Electronic
- Medical Records (EMRs)
- Data Mining and Text Analytics
- Signal Detection Tools
- Machine Learning and AI
- Mobile Applications and Wearable Devices
- Data Sharing and Collaboration Platforms
- Blockchain Technology
- Automated Reporting Systems
- Data Visualization Tools
Luvanka Hanxhari
Novartis
Global RMP Lead & Deputy to Head of RMP Office
Digital solutions on RMP Educational Materials
- GVP Modules' expectations on the usage of digital tools on the provision of RMP Ems
- Internal and external tools available
- How to choose among available options
- Challenges and Opportunities on the digital usage of RMP EMs
Nikolina Nuic
Philip Morris International
Manager Safety Database
Is your AI under control?
- How PMI has implemented automated system
- High level automation we have been using
- Lessons learned
- system performance metrics is key
- constantly learning about the system
- controls we have put in place
As with any drug, there are risks associated with its use, including the possibility of adverse reactions, interactions with other medications, and the risk that the product may not function as effectively as anticipated. Pronovea is bringing together pharmacovigilance pioneers and healthcare innovators to collaborate to enhance drug safety and risk management. From the profound impact of Advanced Therapy Medicinal Products (ATMPs) to harnessing the power of AI and intelligent automation, from the global harmonization of safety approaches to the strategic insights of smart PV outsourcing, we leave no stone unturned. Join us as we explore transformative trends, embrace real-world evidence, and navigate the latest updates in pharmacovigilance. Together, let's forge a path to a safer, more informed healthcare landscape where patients can trust the medications they receive.