Pharmacovigilance teams are managing more complex development programs, expanding data sources, and growing volumes of safety information. They must also maintain compliant, inspection-ready systems and process safety information promptly. This webinar will explore how AI-enabled pharmacovigilance can help streamline these operations while maintaining quality, oversight, and human accountability.
Key topics will include how AI can improve the flow of safety information, increase visibility across pharmacovigilance processes, and support operational pharmacovigilance activities such as case intake, information extraction, case routing, distribution and workflow management.
Experts from Allucent and Nextrove will share practical experience from implementing AI-enabled pharmacovigilance solutions, discussing key considerations for adoption, integration into existing workflows, and lessons learned from real-world implementation. The session will also explore emerging AI applications beyond operational case processing, including capabilities that can support EU QPPVs and safety leaders through improved access to pharmacovigilance metrics and operational information.
The controls needed for successful AI implementation, including validation, performance monitoring, data privacy, human oversight, and governance, will also be addressed. These considerations are essential for maintaining patient safety, regulatory compliance, and human accountability.
Register for this webinar to learn how AI-enabled pharmacovigilance can be integrated into operational workflows, explore practical implementation considerations, and understand the principles needed to maintain patient safety, regulatory compliance, and human accountability.
Speakers
Ian Kovacs, PhD, Global Head of Pharmacovigilance, Allucent
Ian Kovacs has more than 25 years’ professional experience in all areas of pharmacovigilance (including EU QPPV) and medical information, gained within both pharmaceutical companies and CROs. In his current position as Global Head of Pharmacovigilance at Allucent, he is responsible for providing strategic leadership and oversight of global pharmacovigilance services provided by Allucent.
Ian is a highly motivated business leader with a proven record of accomplishment in establishing and maintaining profitable and compliant pharmacovigilance systems and leading operational teams. He is driven by the ability to develop and lead motivated and effective teams whilst supporting companies to develop and execute effective pharmacovigilance strategies in an era of AI and automation. Ian holds a Bachelor’s Degree in Pharmacology and a PhD in Hematopathology from the University of Southampton.
Georgia Kolangi, MSc, Associate Director, Pharmacovigilance, Allucent
Georgia Kolangi has more than 17 years of professional experience in pharmacovigilance and medical information, gained across global contract research organizations. Throughout her career, she has developed extensive expertise in all aspects of pharmacovigilance, spanning operational delivery, regulatory compliance, post-marketing & clinical safety, quality management and pharmacovigilance leadership.
Prior to joining Allucent, Georgia held several strategic leadership roles within global CROs, most recently serving as an EU/UK Qualified Person for Pharmacovigilance (QPPV). In her current position as Associate Director, Pharmacovigilance at Allucent, she oversees post-marketing pharmacovigilance activities, leads the development of Allucent’s Local Pharmacovigilance Network and serves as an EU QPPV.
Georgia has a particular interest in pharmacovigilance governance, global post-marketing operations and the application of innovative technologies to support the evolution of pharmacovigilance.
Rosanna Eccel, Head of Global Pharmacovigilance, Nextrove
Rosanna Eccel has over 30 years of experience in the pharmaceutical industry with the last 18 devoted to pharmacovigilance including working as Vice President, Head of Global Pharmacovigilance Office, at Pfizer.
She brings deep domain expertise of pharmacovigilance business, relevant operations, and interaction with technology. During her career she managed numerous pharmacovigilance system integrations and business process assessments, re-alignments, and implementations. During her tenure at Pfizer Rosanna was instrumental in shaping the pharmacovigilance system by leading the drug safety units across the world.
Who Should Attend?
This webinar will appeal to:
- Pharmacovigilance professionals, QPPV office
- Regulatory Affairs professionals
- Quality Assurance & Compliance professionals
- CMOs
- Medical Affairs professionals
- Clinical Operations professionals
- AI and Digital Innovation teams in life sciences
What You Will Learn
Attendees will:
- Learn how AI is being applied in operational pharmacovigilance today
- Explore practical considerations for implementing AI in pharmacovigilance
- Discover how AI-enabled capabilities can be integrated into pharmacovigilance operations
- Understand how AI can be implemented while maintaining patient safety, regulatory compliance and human accountability
Xtalks Partner
Allucent
Allucent is on a mission to help bring new therapies to light by solving the distinct challenges of small and mid-sized biotech companies. The company is purpose-built through the convergence of leading providers to address this unmet need. Today, Allucent is a global provider of comprehensive drug development solutions, including clinical trial operations, regulatory strategy, clinical pharmacology, pharmacovigilance, and biostatistical programming consulting. With more than 30 years of experience in over 70 countries, Allucent’s individualized partnership approach provides experience-driven insights and expertise to assist its clients in successfully navigating the complexities of delivering novel treatments to patients.
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