The World Drug Safety Congress (WDSC) brought together over 1,500 registered attendees, from diverse sectors such as pharma, biotech, regulatory, academia and service vendors. This cornerstone event for the pharmacovigilance (PV) community provided a platform to discuss cutting-edge advancements, regulatory challenges, and future trends in ensuring drug safety. The overarching theme of the three-day event was “Advancing pharmacovigilance in a changing landscape”. Three of ICON’s Pharmacovigilance team members attended: Quintin van Wyk, Vice President, Carolyn Clark, Senior Director and Joash Krishna, Director. In this blog they reflect on some of the topics discussed and look at emerging PV trends.
Advanced technologies in pharmacovigilance
The rise of AI and machine learning is reshaping drug safety practices. The pharmacovigilance community is leveraging these technologies to enhance data analysis, improve signal detection, and transition pharmacovigilance from manual to automated workflows. During discussions conference speakers anticipated a future where predictive analytics and advanced algorithms will enable proactive risk management. This will contribute to better patient outcomes.
AI and machine learning in patient safety
AI is still a hot topic as the pharmaceutical and biotech sectors continue to explore its potential. AI presents opportunities to improve patient safety through automation and efficiency. Conference sessions explored the shift from traditional manual approaches to innovative AI-powered solutions for case processing, adverse event reporting, and safety surveillance. By reducing human error and improving scalability, these technologies are driving the next wave of transformation in PV. ICON has an established suite of AI and machine learning tools which enable our customers to streamline operations, ensuring timely and informed decision-making.
Global pharmacovigilance and regulatory compliance
Navigating the complexities of global pharmacovigilance and regulatory compliance remains challenging. Regulations vary across regions so tailored strategies are essential to ensure compliance and avoid timeline delays. Speakers shared insights on how to align with international standards while addressing local regulatory nuances. These discussions offered actionable approaches to overcome barriers and maintain compliance on a global scale. With deep expertise in global regulatory frameworks, our regulatory teams develop customised strategies to help our customers navigate these challenges seamlessly.
Signal Detection: Challenges and solutions
Signal detection will always be a critical aspect of pharmacovigilance and something which ICON pharmacovigilance experts monitor with advanced analytics tools. Some common challenges discussed at WDSC 2024 included data quality, integration across systems, and signal validation. Industry professionals highlighted the importance of adopting advanced analytics tools, fostering cross-functional collaboration, and streamlining workflows for real-time signal management.
Looking ahead: The future of pharmacovigilance
The WDSC underscored the importance of collaboration, innovation, and adaptability to address the evolving challenges of pharmacovigilance. With AI and global regulatory compliance at the forefront, the industry continues to transform, driving safer outcomes for patients worldwide. The insights gained and connections made at the event reaffirm the critical role of community-driven dialogue in shaping the future of drug safety. ICON’s comprehensive pharmacovigilance services ensure that our customers can maintain their focus on their core mission – improving patient safety. By partnering with ICON they access the expertise and resources needed to confidently navigate the future of pharmacovigilance, with efficient, scalable and customised solutions.
Contact us for a personalised pharmacovigilance assessment for your clinical and postmarketing programs.
In this section
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Digital Disruption
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Clinical strategies to optimise SaMD for treating mental health
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Digital Disruption: Surveying the industry's evolving landscape
- AI and clinical trials
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Clinical trial data anonymisation and data sharing
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Clinical Trial Tokenisation
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Closing the evidence gap: The value of digital health technologies in supporting drug reimbursement decisions
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Digital disruption in biopharma
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Disruptive Innovation
- Remote Patient Monitoring
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Personalising Digital Health
- Real World Data
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The triad of trust: Navigating real-world healthcare data integration
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Clinical strategies to optimise SaMD for treating mental health
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Patient Centricity
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Agile Clinical Monitoring
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Capturing the voice of the patient in clinical trials
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Charting the Managed Access Program Landscape
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Developing Nurse-Centric Medical Communications
- Diversity and inclusion in clinical trials
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Exploring the patient perspective from different angles
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Patient safety and pharmacovigilance
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A guide to safety data migrations
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Taking safety reporting to the next level with automation
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Outsourced Pharmacovigilance Affiliate Solution
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The evolution of the Pharmacovigilance System Master File: Benefits, challenges, and opportunities
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Sponsor and CRO pharmacovigilance and safety alliances
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Understanding the Periodic Benefit-Risk Evaluation Report
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A guide to safety data migrations
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Patient voice survey
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Patient Voice Survey - Decentralised and Hybrid Trials
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Reimagining Patient-Centricity with the Internet of Medical Things (IoMT)
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Using longitudinal qualitative research to capture the patient voice
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Agile Clinical Monitoring
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Regulatory Intelligence
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An innovative approach to rare disease clinical development
- EU Clinical Trials Regulation
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Using innovative tools and lean writing processes to accelerate regulatory document writing
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Current overview of data sharing within clinical trial transparency
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Global Agency Meetings: A collaborative approach to drug development
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Keeping the end in mind: key considerations for creating plain language summaries
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Navigating orphan drug development from early phase to marketing authorisation
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Procedural and regulatory know-how for China biotechs in the EU
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RACE for Children Act
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Early engagement and regulatory considerations for biotech
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Regulatory Intelligence Newsletter
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Requirements & strategy considerations within clinical trial transparency
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Spotlight on regulatory reforms in China
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Demystifying EU CTR, MDR and IVDR
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Transfer of marketing authorisation
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An innovative approach to rare disease clinical development
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Therapeutics insights
- Endocrine and Metabolic Disorders
- Cardiovascular
- Cell and Gene Therapies
- Central Nervous System
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Glycomics
- Infectious Diseases
- NASH
- Oncology
- Paediatrics
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Respiratory
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Rare and orphan diseases
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Advanced therapies for rare diseases
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Cross-border enrollment of rare disease patients
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Crossing the finish line: Why effective participation support strategy is critical to trial efficiency and success in rare diseases
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Diversity, equity and inclusion in rare disease clinical trials
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Identify and mitigate risks to rare disease clinical programmes
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Leveraging historical data for use in rare disease trials
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Natural history studies to improve drug development in rare diseases
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Patient Centricity in Orphan Drug Development
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The key to remarkable rare disease registries
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Therapeutic spotlight: Precision medicine considerations in rare diseases
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Advanced therapies for rare diseases
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Transforming Trials
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Accelerating biotech innovation from discovery to commercialisation
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Ensuring the validity of clinical outcomes assessment (COA) data: The value of rater training
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Linguistic validation of Clinical Outcomes Assessments
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Optimising biotech funding
- Adaptive clinical trials
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Best practices to increase engagement with medical and scientific poster content
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Decentralised clinical trials
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Biopharma perspective: the promise of decentralised models and diversity in clinical trials
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Decentralised and Hybrid clinical trials
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Practical considerations in transitioning to hybrid or decentralised clinical trials
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Navigating the regulatory labyrinth of technology in decentralised clinical trials
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Biopharma perspective: the promise of decentralised models and diversity in clinical trials
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eCOA implementation
- Blended solutions insights
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Implications of COVID-19 on statistical design and analyses of clinical studies
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Improving pharma R&D efficiency
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Increasing Complexity and Declining ROI in Drug Development
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Innovation in Clinical Trial Methodologies
- Partnership insights
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Risk Based Quality Management
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Transforming the R&D Model to Sustain Growth
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Accelerating biotech innovation from discovery to commercialisation
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Value Based Healthcare
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Strategies for commercialising oncology treatments for young adults
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US payers and PROs
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Accelerated early clinical manufacturing
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Cardiovascular Medical Devices
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CMS Part D Price Negotiations: Is your drug on the list?
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COVID-19 navigating global market access
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Ensuring scientific rigor in external control arms
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Evidence Synthesis: A solution to sparse evidence, heterogeneous studies, and disconnected networks
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Global Outcomes Benchmarking
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Health technology assessment
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Perspectives from US payers
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ICER’s impact on payer decision making
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Making Sense of the Biosimilars Market
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Medical communications in early phase product development
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Navigating the Challenges and Opportunities of Value Based Healthcare
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Payer Reliance on ICER and Perceptions on Value Based Pricing
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Payers Perspectives on Digital Therapeutics
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Precision Medicine
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RWE Generation Cross Sectional Studies and Medical Chart Review
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Survey results: How to engage healthcare decision-makers
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The affordability hurdle for gene therapies
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The Role of ICER as an HTA Organisation
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Strategies for commercialising oncology treatments for young adults
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