17^th Global Pharmacovigilance & Clinical Trials Summit

Artificial Intelligence (AI) and automation are revolutionizing signal detection by accelerating data analysis, reducing manual workload, and improving accuracy. This session discusses how machine learning algorithms and natural language processing are being applied to vast datasets from spontaneous reports, EHRs, and literature sources to identify potential safety signals earlier and more reliably. Automation of routine pharmacovigilance processes, such as case triage and duplicate detection, is also examined. Experts will highlight the importance of data validation, model transparency, and regulatory acceptability of AI-driven tools. Practical examples of successful implementation in industry settings will demonstrate how AI augments pharmacovigilance efficiency while maintaining scientific and ethical standards.

Modern clinical trials are increasingly prioritizing the patient experience to enhance trial participation, retention, and data relevance. This session delves into strategies for embedding patient-centric principles across trial design, conduct, and follow-up. Topics include the use of decentralized and hybrid trial models, integration of patient-reported outcomes (PROs), and adaptive designs that respond to patient needs. The value of involving patients in protocol development and informed consent processes is emphasized to ensure clarity and inclusivity. By leveraging digital health technologies, real-time feedback loops, and personalized engagement tactics, sponsors can align clinical trial goals with patient expectations. Attendees will explore successful examples of how patient-centric trials improve study efficiency, data quality, and long-term healthcare outcomes.

Post-marketing surveillance plays a critical role in monitoring drug safety and efficacy in real-world settings. This session explores how Real-World Data (RWD) from electronic health records, insurance claims, registries, and digital platforms are transforming post-authorization safety studies (PASS). Key discussions include methodologies for capturing and analyzing RWD, maintaining data integrity, and integrating findings into pharmacovigilance systems. Regulatory perspectives on the acceptability and standardization of RWD for decision-making are also addressed. Case studies will demonstrate how real-world evidence contributes to early detection of adverse drug reactions, supports label updates, and guides risk mitigation strategies. Attendees will leave with practical insights into leveraging RWD to enhance drug safety oversight and patient care.

Staying abreast of global regulatory developments is essential for maintaining pharmacovigilance compliance and ensuring smooth clinical operations. This session provides an in-depth overview of evolving requirements from major regulatory bodies such as the FDA, EMA, MHRA, PMDA, and Health Canada. Discussions will highlight recent updates on ICH guidelines, EudraVigilance standards, periodic safety reporting, and Good Pharmacovigilance Practices (GVP). Focus is also placed on harmonizing compliance efforts across multinational trials and addressing challenges in regions with emerging regulatory infrastructures. Expert insights into regulatory inspections, common deficiencies, and best practices for documentation and communication will be provided. The session equips attendees with the knowledge to proactively adapt to regulatory changes and maintain high-quality safety systems.

Ensuring data integrity is foundational to the credibility of clinical trial outcomes and pharmacovigilance processes. This session focuses on maintaining the reliability, accuracy, and traceability of clinical and safety data, particularly in the context of electronic systems such as the electronic Trial Master File (eTMF). Participants will explore current best practices for implementing ALCOA+ principles, managing audit trails, and securing electronic records. Emphasis is placed on system validation, user access controls, and data lifecycle management. Real-world scenarios will demonstrate how lapses in data integrity can compromise trial results and lead to regulatory actions. Guidance on audit readiness, compliance with 21 CFR Part 11, and integration of eTMF with other digital platforms will be discussed.

Benefit-risk assessment is a continuous process that informs key decisions across drug development stages. This session presents frameworks and methodologies for evaluating the therapeutic value of investigational products in relation to their potential risks. Quantitative and qualitative tools such as MCDA (Multi-Criteria Decision Analysis) and BRAT (Benefit-Risk Action Team) models are explored. Regulatory expectations for structured benefit-risk evaluations in clinical trial submissions and safety updates are discussed. Practical examples will highlight how sponsors use benefit-risk profiles to guide go/no-go decisions, optimize trial designs, and support regulatory approvals. Emphasis is also placed on communicating benefit-risk findings transparently to stakeholders, including patients and health authorities.

Rare and orphan drug development presents unique pharmacovigilance challenges due to limited patient populations, heterogeneous data, and accelerated approval pathways. This session examines strategies to ensure effective safety monitoring in these contexts. Topics include leveraging patient registries, using surrogate endpoints, and applying innovative methodologies to detect and assess adverse events. Collaborative approaches involving regulators, patient advocacy groups, and academia are emphasized to enhance data quality and interpretation. The role of real-world evidence and adaptive safety surveillance plans will be discussed. Attendees will learn how tailored pharmacovigilance frameworks can ensure the safe and ethical use of therapies for rare diseases while addressing unmet medical needs.

Digital therapeutics (DTx) represent a new frontier in healthcare, offering software-driven interventions for various medical conditions. This session explores the pharmacovigilance implications of DTx, including the identification, assessment, and management of software-related adverse events. Attendees will learn about regulatory expectations for safety monitoring of DTx products and how to adapt traditional pharmacovigilance systems for digital contexts. Topics include user data protection, interoperability with health records, and tracking efficacy in real-world usage. The importance of usability testing, continuous performance monitoring, and cross-functional collaboration is highlighted. Real-world case examples will showcase how companies ensure safe deployment and lifecycle management of digital therapeutics.

Real-time safety data monitoring is essential for timely detection of emerging risks and informed decision-making during clinical trials. This session outlines best practices for establishing centralized monitoring systems that enable continuous data review and proactive safety signal identification. The integration of dashboards, risk indicators, and automated alerts is discussed to enhance data visualization and responsiveness. Participants will learn how to interpret key safety metrics, collaborate with Data Monitoring Committees (DMCs), and escalate issues efficiently. Case examples will illustrate how real-time monitoring improves patient protection, trial continuity, and regulatory compliance. Practical guidance on system validation and cross-functional coordination will be shared.

Contract Research Organizations (CROs) play a pivotal role in managing and executing clinical trials, particularly in complex, multi-center studies. This session highlights how sponsors can effectively collaborate with CROs to ensure high-quality trial conduct, compliance, and timely delivery. Key topics include CRO selection and oversight, defining roles and responsibilities, and establishing communication channels. Best practices for performance tracking, risk management, and issue resolution are covered. Participants will also explore how CROs contribute to pharmacovigilance activities, from safety data collection to regulatory submissions. Real-world case studies will demonstrate the value of strategic partnerships with CROs in achieving operational excellence and regulatory success.

Risk-Based Monitoring (RBM) has become a standard approach to improve trial efficiency and data quality while focusing oversight on critical risks. This session delves into the design and implementation of RBM strategies using centralized, remote, and on-site monitoring techniques. Attendees will learn how to identify key risk indicators, develop monitoring plans, and leverage technology platforms for real-time tracking. Emphasis is placed on cross-functional collaboration between data managers, monitors, and safety teams. Case studies will illustrate how RBM reduces monitoring burden, enhances protocol compliance, and supports adaptive trial designs. Regulatory perspectives on RBM adoption and documentation requirements will also be addressed.

Early phase clinical trials play a critical role in evaluating the safety and tolerability of new drugs. Accurate and timely safety reporting during this phase is essential for identifying initial adverse effects and shaping the development pathway. As investigational drugs are tested in humans for the first time, researchers must employ robust safety monitoring systems that comply with regulatory standards. These include adverse event (AE) and serious adverse event (SAE) reporting protocols, real-time monitoring dashboards, and cross-functional collaboration among investigators, safety officers, and sponsors. Technology-driven solutions like electronic data capture (EDC) and centralized monitoring systems streamline the reporting process, enabling quicker detection of safety signals. Harmonization of safety reporting requirements across regions is also pivotal for global development programs. This session examines current methodologies, global requirements, and emerging best practices for ensuring participant safety and data integrity in early phase trials, ultimately supporting the safe progression of promising therapies.

Vaccines and biologics present unique pharmacovigilance challenges due to their complex structures, immune-mediated mechanisms, and wide-scale population use. Post-marketing surveillance for these products is vital to detect rare or long-term adverse events that may not be captured during pre-approval studies. Pharmacovigilance efforts must focus on passive and active surveillance systems, vaccine safety datalink (VSD) analyses, and signal detection tools tailored to biological therapies. Regulatory agencies such as the FDA and EMA mandate rigorous safety evaluations, periodic safety update reports (PSURs), and risk management plans (RMPs) specifically adapted to biologics. Transparency in communicating safety data and fostering public trust is also essential, especially in the context of vaccine hesitancy. The evolving landscape of biosimilars further demands refined pharmacovigilance strategies to assess immunogenicity and batch consistency. This session explores the integration of real-world data, post-authorization safety studies (PASS), and collaborative global safety initiatives that ensure comprehensive pharmacovigilance for vaccines and biologics.

Global pharmacovigilance has evolved rapidly, yet emerging challenges continue to reshape the field. Differences in regulatory frameworks, reporting standards, and local infrastructure create inconsistencies in adverse event reporting and data harmonization. Additionally, the increasing volume of real-world evidence, expansion into low- and middle-income markets, and the complexity of biologics and combination therapies necessitate adaptive pharmacovigilance models. Data privacy regulations such as GDPR add further complexity to cross-border data sharing. Language barriers, limited technological access, and underreporting in certain regions further hinder the global safety network. Moreover, the rise of digital health tools introduces novel sources of safety data that must be validated and incorporated into pharmacovigilance processes. There is also an urgent need for capacity-building initiatives and international collaborations to ensure equitable safety surveillance worldwide. This session delves into the multifaceted nature of these challenges, highlighting strategic solutions and innovations that can support harmonized global pharmacovigilance while protecting public health across diverse populations.

Ethics and transparency are the cornerstone of clinical research and pharmacovigilance. Upholding these principles ensures participant rights, data credibility, and public confidence in medical research. Ethical conduct demands informed consent, protection of vulnerable populations, and adherence to international guidelines such as the Declaration of Helsinki and Good Clinical Practice (GCP). Transparency, on the other hand, requires open sharing of trial protocols, results, and adverse events. This includes timely reporting to registries, regulatory authorities, and peer-reviewed publications. Sponsors and investigators are increasingly expected to disclose funding sources and potential conflicts of interest. Digital trial platforms and decentralized models further challenge traditional ethics frameworks, necessitating updated oversight mechanisms. This session focuses on the integration of ethics into trial design, conduct, and pharmacovigilance activities. It also highlights regulatory mandates and voluntary initiatives aimed at fostering a culture of openness and accountability in clinical research.

Integrating pharmacovigilance throughout the entire drug life cycle enhances patient safety and regulatory compliance. From preclinical development through post-market surveillance, safety data must be systematically collected, analyzed, and acted upon. Early incorporation of risk management strategies helps shape trial protocols and mitigate anticipated risks. During clinical development, adaptive monitoring and periodic safety reports ensure continuous safety oversight. Once approved, ongoing pharmacovigilance activities such as spontaneous reporting, signal detection, and risk minimization are vital to identify and manage real-world safety issues. Regulatory frameworks increasingly emphasize lifecycle risk management, requiring dynamic updates to safety profiles and risk mitigation plans. Cross-functional collaboration among clinical, regulatory, and safety teams is essential for seamless data integration. This session presents methodologies and tools for embedding pharmacovigilance at every stage of development, ultimately fostering a proactive safety culture that benefits both regulators and patients.

The rise of personalized and precision medicine has transformed traditional drug development and safety monitoring paradigms. These tailored therapies, often based on genetic, biomarker, or molecular profiling, introduce new challenges for pharmacovigilance. The small, genetically defined patient populations involved may lead to limited pre-market safety data, necessitating enhanced post-marketing surveillance. Additionally, the individualized nature of treatment response requires adaptive signal detection tools and robust risk-benefit analyses tailored to subgroups. Digital tools such as electronic health records (EHRs), wearable devices, and genomic databases play an increasingly vital role in monitoring therapy-specific adverse events. Regulatory bodies are adapting frameworks to evaluate safety signals in the context of individualized treatment. This session explores how pharmacovigilance systems are evolving to meet the safety needs of precision therapies and how real-world evidence can support ongoing evaluation in diverse patient populations.

Efficient signal detection and prioritization are fundamental to modern pharmacovigilance. As data sources expand ranging from clinical trials to spontaneous reports, electronic health records, and social media systems must filter and rank potential safety signals based on their clinical significance and risk potential. Tools like disproportionality analysis, Bayesian models, and machine learning algorithms help streamline signal detection. Prioritization frameworks consider multiple factors, including severity, frequency, patient demographics, and available therapeutic alternatives. Once validated, signal management involves thorough risk assessment, cross-functional review, and regulatory communication. Clear documentation and audit trails are essential to ensure traceability and accountability. This session highlights advanced techniques and best practices for signal management, enabling timely interventions that enhance patient safety while minimizing unnecessary alarm or resource expenditure.

Regulatory audits and inspections are crucial components of a robust pharmacovigilance system, ensuring compliance with national and international safety standards. Preparing for these evaluations requires well-documented processes, trained personnel, and centralized access to safety data. Common focus areas during inspections include adverse event reporting timelines, signal detection procedures, risk management plans, and vendor oversight. Gaps in documentation or process adherence can lead to significant findings and regulatory penalties. Implementing routine internal audits, mock inspections, and CAPA (Corrective and Preventive Action) systems can strengthen readiness and promote continuous improvement. Furthermore, aligning with global guidance such as ICH E2E and GVP modules enhances harmonization across regions. This session explores practical strategies for audit preparedness, successful navigation of inspections, and ongoing PV compliance management to build resilient and credible safety systems.