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Registration & Expo Hall Opens
Sponsored by EVERSANA.
In an increasingly dynamic global healthcare landscape, the need for agile, forward-thinking pharmacovigilance systems has never been more urgent. This panel will explore how real-time technologies, predictive analytics, AI/ML tools, and collaborative data ecosystems are revolutionizing the way safety signals are detected, assessed, and acted upon.
Sponsored by Oracle Health and Life Sciences.
Networking, Posters, & Expo Hall Break
Attendees will gain a deep understanding of how AI, machine learning, and automation are revolutionizing pharmacovigilance by streamlining case processing, enhancing signal detection, and driving operational efficiency. They will explore real-world applications, innovative tools, and forward-looking strategies to build trust in AI and future-proof safety operations across the drug development lifecycle.
Attendees will gain insights into evolving global pharmacovigilance regulations, harmonization efforts, and compliance strategies across diverse markets. Through expert perspectives and case studies, they will explore how to navigate complex regulatory frameworks, align with international guidance, and implement best practices to ensure safety and compliance on a global scale.
Attendees will gain practical strategies for identifying, assessing, and mitigating safety risks throughout the product lifecycle. They will explore evolving approaches to benefit-risk management, REMS, and post-market surveillance, with insights into regulatory expectations and innovative tools to enhance patient safety and product oversight.
Attendees will gain a forward-looking view of how emerging technologies and advanced data analytics are shaping the future of pharmacovigilance. They will explore innovations in real-world evidence, signal detection, and data integration to enhance decision-making, optimize safety monitoring, and support more proactive risk management.
To be announced.
To be announced.
To be announced.
Automation is already reshaping pharmacovigilance — quietly, compliantly, and effectively. This session explores why automation, not AI, is the real innovation in safety-critical workflows. We’ll discuss regulatory expectations, current use cases, and how rule-based systems deliver reliable, auditable results. Whilst AI remains aspirational, automation is operational — and inspection-ready!
Objectives include:
Sponsored by PharSafer.
To be announced.
Sponsored by COD Research.
Sponsored by Veeva.
This session coverskey safety updatesfor cellular therapies currently under development or approved for use. When cellular therapies are ready for clinical evaluation, there are significant challenges in managing product safety.
Key Topics Covered:
Sponsored by APCER Life Sciences
Reserved for sponsor.
This presentation describes a novel AI-driven system designed to support the authoring of Periodic Benefit-Risk Evaluation Reports (PBRERs), a critical component of pharmacovigilance. The system leverages generative AI, natural language processing, and machine learning to analyze safety data, generate draft content, and ensure alignment with regulatory expectations. Early prototypes have shown promising results in reducing manual workload and improving quality, consistency, and traceability in reporting. The presentation will share key technical insights, challenges encountered, and the potential impact on drug safety operations.
This session introduces an efficiency-focused approach to affiliate auditing. We will explore streamlined tactics, enabling tools, and transformation strategies that shift audits from routine assessments to high-impact, risk-based evaluations. The session will involve a discussion on how to enhance audit planning and enable data-driven decision-making - ensuring your audits deliver real value in today’s complex environment.
To be announced.
Sponsored by IQVIA.
Patient safety remains the foundation of our work as pharmacovigilance professionals. Tailoring safety monitoring strategies to align with the unique characteristics of treatment types, disease areas, and patient populations is paramount. This session delves into key pharmacovigilance practices in gene therapy, highlighting specific considerations for safety monitoring during clinical trials and their role in shaping product labels. We’ll also briefly explore the nuances of pharmacovigilance in the commercial landscape for gene therapies. Join us for this engaging discussion and share your valuable insights and experiences.
Sponsored by Soterius.
To be announced
Sponsored by Pinnaxis.
To be announced.
Reserved for sponsor.
Join experienced Pharmacovigilance Systems Leaders to discuss what it really takes to successfully implement reality vs. hype and what's changed with AI. We'll cover navigating overselling during the sales cycle, expectation setting, culture and commitment to change - with plenty of lessons learnt along the way. Not one to be missed for PV systems or business leaders looking for actionable insight from industry veterans representing a diverseset of organizations.
As outsourcing in pharmacovigilance accelerates, how do we ensure patient safety isn’t compromised by cost-driven decisions? This panel explores the role of QA and QMS in the vendor selection process, making the case for pre-qualification audits and robust quality metrics before contracts are signed.
Join our thought leaders to debate how we can embed quality from the outset — and why PV QA voices must be central to outsourcing strategy.
The objectives of this panel discussion will:
Sponsored by PharSafer.
Sponsored by Clinigen.
To be announced
Sponsored by Ultragenic Research & Technologies LLC.
Sponsored by Oracle Health.
Networking, Poster, & Expo Break
Attendees will gain a deep understanding of how AI, machine learning, and automation are revolutionizing pharmacovigilance by streamlining case processing, enhancing signal detection, and driving operational efficiency. They will explore real-world applications, innovative tools, and forward-looking strategies to build trust in AI and future-proof safety operations across the drug development lifecycle.
Attendees will gain insights into evolving global pharmacovigilance regulations, harmonization efforts, and compliance strategies across diverse markets. Through expert perspectives and case studies, they will explore how to navigate complex regulatory frameworks, align with international guidance, and implement best practices to ensure safety and compliance on a global scale.
Attendees will gain a forward-looking view of how emerging technologies and advanced data analytics are shaping the future of pharmacovigilance. They will explore innovations in real-world evidence, signal detection, and data integration to enhance decision-making, optimize safety monitoring, and support more proactive risk management.
To be announced.
To be announced.
To be announced.
Sponsored by Syneos Health.
Panelists to be announced.
Sponsred by Orbit by Feith Systems.
Sponsored by ThermoFisher Scientific.
Sponsored by Parexel.
The pharmacovigilance landscape is increasingly regulated, necessitating efficient and compliant data migration strategies for medium and small enterprises. This presentation delves into the core aspects of data migration, focusing on practical methods, ensuring data integrity, and developing robust migration plans.
We begin by exploring various data migration methods, including manual, E2B, and programmatic approaches, assessing their suitability based on dataset complexity and resource availability. Ensuring data integrity is paramount; thus, we outline best practices for validation and quality assurance, emphasizing compliance with regulatory standards.
Developing a comprehensive data migration plan is crucial, and this presentation provides strategic insights into planning, risk management, and resource allocation to optimize migration processes. We address common technical challenges, such as system compatibility and data cleaning, offering solutions to streamline migration efforts.
Cost and resource management are key considerations, particularly for smaller enterprises. We discuss efficient management strategies to minimize expenses while maximizing outcomes. Lastly, we touch on emerging trends, including AI-driven solutions, that promise to enhance migration efficiency and compliance.
This presentation aims to equip medium and small enterprises with the knowledge and tools needed to successfully navigate the complexities of pharmacovigilance data migration, ensuring seamless transitions while maintaining regulatory compliance.
Medical doctors play a critical, yet often underappreciated, role in the risk management lifecycle of medical devices. Their clinical insight is essential for identifying potential hazards, assessing real-world risks, and shaping safer, more effective products. This presentation explores how physicians contribute across key phases of medical device development and post-market surveillance, including clinical risk identification, usability assessment, adverse event analysis, and patient safety advocacy.
Reserved for sponsor.
Reserved for sponsor.
Sponsored by Techsol Life Sciences.
As emerging biotech companies bring novel therapies to market at record pace, patient safety must remain a core pillar of success. Yet smaller organizations often face unique challenges, including limited resources, evolving infrastructure, and the need to navigate complex global regulatory landscapes. This session will outline practical, scalable strategies to build a robust patient safety framework from early development through commercialization. Topics will include embedding safety considerations into clinical development, leveraging technology and partnerships for efficient pharmacovigilance, aligning safety strategy with evolving regulations, and fostering a proactive safety culture across small teams. Attendees will gain a blueprint for prioritizing patient protection while maintaining innovation and agility, ensuring safety becomes a catalyst—not a barrier—to growth.
Reserved for Transcelerate.
As the ACNU framework continues to take shape, its implications across the pharmacovigilance (PV) ecosystem are becoming increasingly significant. Takeaways from this panel include:
Panelists to be announced.
Sponsored by Syneos Health.
Reserved for sponsor
Reserved for sponsor.
Reserved for sponsor.
Reserved for sponsor.
When building or supporting country-specific PV, there are legislative, cultural, commercial, as well as strategic variables that need to be considered. Here we discuss the framework and tools we use, as well as the challenges and successes from a collective 2 decades of experience.
The Renal Explorer is the latestopen-source tool from the Interactive Safety Graphics taskforce of the American Statistical Association's Biopharmaceutical Safety Working Group. This session will illustrate how instances of acute renal injury arising in clinical trials can be identified and evaluated by this interactive graphical tool.In addition, the accompanying clinical workflow will be introduced, which guides the safety scientist through a series of evaluations, explains how to interpret the results, all referenced back to the primary medical literature
To be announced.
To be announced.
To be announced.
For many years, real-world data — e.g., administrative claims and electronic health records — have played a critical role in medical product safety through traditional Post-Approval Safety Studies. With advances in real-world data availability, methods, and tools, real-world evidence is increasingly being used as part of routine pharmacovigilance activities in the signal management process. While less well established, there is growing interest in using secondary real-world data for signal detection to identify new safety observations. Covering multiple stakeholder perspectives, this panel will discuss the current state and future potential of real-world data in signal detection
In today’s hyper-connected world, pharmacovigilance professionals are faced with an overwhelming abundance of data—ranging from peer-reviewed literature and clinical reports to social media signals and real-world evidence. While this information explosion holds immense potential for improving drug safety, it also presents significant challenges: fragmentation, duplication, and inequitable access, particularly in low- and middle-income countries (LMICs).
This session will explore how global stakeholders are working to streamline, standardize, and integrate diverse data sources to create more cohesive, actionable pharmacovigilance systems. Speakers will highlight innovative technologies, policy frameworks, and collaborative models that are helping to cut through the noise, prioritize meaningful signals, and democratize access to critical safety information.
A panel on"Navigating Patient Safety: A Comparative Look Across Pharma, Devices, Cosmetics, and Combination Products"would explore the unique and overlapping safety challenges within each sector. Experts would discuss regulatory frameworks, risk management strategies, and post-market surveillance practices tailored to the specific nature of each product type. The conversation would highlight how innovation, globalization, and evolving consumer expectations are reshaping safety protocols. Ultimately, the session would aim to foster a more integrated approach to patient safety across the life sciences spectrum.
Sponsored by Indegene.
To be announced.
To be announced.
Please join us in Hall C for our afternoon keynotes.
Other speakers to be announced.
To be announced.
Other panelists to be announced.
Join us on the expo floor in Hall C for happy hour!
Create your personal agenda –check the favourite icon
Registration & Expo Hall Opens
Sponsored by Parexel.
Sponsored by ArisGlobal.
Pharmacovigilance (PV) is evolving to optimize therapeutic outcomes through personalized safety strategies.Emerging data sources, such as social media and wearable technologies, offer opportunities to gather real-world, patient-generated data, but challenges like data quality, regulatory compliance, and cost pressures necessitate advanced solutions.Automation, AI, and advanced analytics are transforming PV processes, enabling faster, more accurate data processing, signal detection, and risk management.AI-driven approaches unlock insights from unstructured healthcare data, enhance efficiency, and enable novel capabilities, though risks like bias, explainability, and regulatory compliance must be managed.
Personalized safety focuses on understanding patient-specific factors driving adverse events, such as immune-related toxicities in cancer immunotherapy.Research on genetic markers, organoid models, and patient-derived tissues is advancing predictive tools for adverse events like liver injury, myocarditis, and skin toxicity.
Collaborations with health authorities, industry experts, and global research teams are key to fostering transparency and innovation.Personalized medicine supports informed consent and shared decision-making, empowering patients to understand how their genetic and personal data influence treatment.
Networking, Poster, and Expo Hall Break
Attendees will gain a deep understanding of how AI, machine learning, and automation are revolutionizing pharmacovigilance by streamlining case processing, enhancing signal detection, and driving operational efficiency. They will explore real-world applications, innovative tools, and forward-looking strategies to build trust in AI and future-proof safety operations across the drug development lifecycle.
To be announced.
Attendees will gain practical strategies for identifying, assessing, and mitigating safety risks throughout the product lifecycle. They will explore evolving approaches to benefit-risk management, REMS, and post-market surveillance, with insights into regulatory expectations and innovative tools to enhance patient safety and product oversight.
To be announced.
To be announced
To be announced.
To be announced.
Sponsored by UBC.
In this session, you will explore the compelling benefits for pharmaceutical companies in combining human expertise with advanced technology to optimize pharmacovigilance operations. Learn how integrating human insights with cutting-edge tools, including AI and machine learning, pharma companies can achieve greater efficiency, accuracy, and compliance in their safety monitoring processes. Explore real-world examples and industry research to demonstrate the practical applications and benefits of these integrated solutions in enhancing pharmacovigilance operations.
Sponsoredd by IQVIA.
Sponsored by Quartica.
To be announced.
Sponsored by BioPoint.
Sponsored by Alwis Solutions.
To be announced.
Sponsored by Soterius.
Sponsored by ClinChoice.
Reserved for sponsor.
Reserved for sponsor.
Reserved for sponsor.
As the regulatory landscape evolves, the implementation of Reference Safety Information (RSI) has become a cornerstone of effective pharmacovigilance. This panel will explore how companies navigate the complexities of RSI implementation, from aligning with global standards to addressing region-specific regulatory expectations and operational challenges. Experts will discuss strategies for maintaining consistency across regions, integrating updates into safety systems, and ensuring clear communication with investigators and regulators. Attendees will gain practical insights on best practices, common pitfalls, and the future of RSI management in an increasingly connected global environment.
Outsourcing safety activities offers several strategic and operational benefits to sponsors. It spans from Global footprint to cost efficiency encompassing access to specialized knowledge, and scalability, among others. However, there are several challenges that need to be taken into consideration. For example, oversight, differences in time zones, quality issues and non-compliance, vendor dependency, costs, and others. Recognizing those factors is the recipe for a successful outsourcing partnership which will be explored in this panel discussion.
Sponsored by ThermoFisher Scientific.
Reserved for sponsor.
Sponsored by Propharma.
Reserved for sponsor.
Reserved for sponsor.
Networking, Poster, & Expo Break in Expo Hall C
To be announced.
Attendees will gain a deep understanding of how AI, machine learning, and automation are revolutionizing pharmacovigilance by streamlining case processing, enhancing signal detection, and driving operational efficiency. They will explore real-world applications, innovative tools, and forward-looking strategies to build trust in AI and future-proof safety operations across the drug development lifecycle.
To be announced.
Attendees will gain practical strategies for identifying, assessing, and mitigating safety risks throughout the product lifecycle. They will explore evolving approaches to benefit-risk management, REMS, and post-market surveillance, with insights into regulatory expectations and innovative tools to enhance patient safety and product oversight.
To be announced.
To be announced.
In an era of increasing complexity in drug development and real-world use, patient safety must be re-centered as a multidisciplinary, patient-facing function - not just a regulatory requirement. This panel,Rebuilding Safety Around the Patient: Moving Medical Safety Beyond the Silo and Back to the Bedside, explores how safety science can evolve beyond traditional silos to actively engage with patients, clinicians, and data at the point of care. Panelists will share practical strategies for bridging the gap between pharmacovigilance and patient experience through cross-functional collaboration, patient-reported outcomes, and ethical transparency. Join us for a thought-provoking discussion on reimagining medical safety as a bedside ally rather than a back-office function.
To be announced.
Reserved for sponsor.
Reserved for sponsor.
Reserved for sponsor.
Reserved for sponsor.
Reserved for sponsor.
To be announced.
To be announced.
To be announced.
To be announced.
To be announced.
To be announced.