Real-World Pharmacovigilance with OXON and SafeMed: “Accelerating approval through real-time patient safety & drug monitoring”
Webinar Details
Date: 26 February 2026
Time: 5pm CET | 4pm UK | 11am EST | 8am PST
Duration: 90 minutes
Platform: GoToWebinar
On 26 February 2026, OXON Epidemiology, in collaboration with SafeMed, will host a live expert-led webinar focused on real-world pharmacovigilance and the role of validated, real-time systems in supporting regulatory and reimbursement decision-making.
As regulatory expectations continue to evolve, traditional routes to marketing authorisation are increasingly complemented by robust real-world evidence (RWE) capable of demonstrating long-term safety and effectiveness in routine clinical practice. This session will explore how continuous, real-time pharmacovigilance can strengthen benefit–risk evaluation beyond clinical trials.
Key topics include:
- Regulatory & reimbursement challenges
- Real-time RWE in approval pathways
- Hierarchical vs composite endpoints
- SafeMed system demonstration
Addressing Current Regulatory and Reimbursement Challenges
The webinar will examine key challenges faced by sponsors and regulators in the post-authorisation phase, including:
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The integration of real-world evidence into regulatory submissions
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Continuous safety monitoring in routine care
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The advantages of hierarchical versus conventional composite endpoints
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The role of real-time RWE in supporting reimbursement and market access decisions
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Practical implementation of validated pharmacovigilance systems
A live demonstration of the SafeMed platform will illustrate how structured digital workflows can support compliant, scalable safety monitoring while reducing operational burden for sponsors and sites.
Scientific and Methodological Leadership
The session will feature contributions from internationally recognised experts in pharmacovigilance, epidemiology and real-world research:
Professor Thomas MacDonald MBChB MD FRCP
Emeritus Professor of Clinical Pharmacology, University of Dundee. Professor MacDonald is a globally recognised authority in drug safety and pharmacovigilance, author of more than 530 publications (H-index 73), and advisor to EMA, MHRA and FDA on safety and post-authorisation evidence generation.
Dr Nawab Qizilbash MBChB MRCP MSc DPhil
Chief Medical Officer and Senior Clinical Epidemiologist at OXON, and Honorary Associate Professor at the London School of Hygiene & Tropical Medicine. Dr Qizilbash has extensive experience leading PASS, PMS and PAES studies across Europe and the United States.
Krists Zutis BSc (Hons)
Chief Technology Officer of SafeMed Ltd. With a background in regulated healthcare software and clinical research systems, he has led the development of validated digital platforms for real-time patient safety monitoring.
Strengthening Real-World Evidence Through Collaboration
The OXON–SafeMed collaboration combines methodological leadership in safety and post-authorisation studies with validated digital infrastructure designed for real-time pharmacovigilance.
This integrated approach supports:
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Continuous real-world safety and effectiveness monitoring
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Regulator-ready evidence generation aligned with EMA, MHRA and FDA expectations
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Scalable study architectures for innovative therapies
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Enhanced support for reimbursement and market access decisions
By bridging clinical research and routine care, real-time pharmacovigilance models contribute to more sustainable patient access and improved regulatory confidence throughout the product lifecycle.