3rd AMERICA DRUG SAFETY & AI 2025
World’s greatest minds in drug safety, pharmacovigilance, data analysis, reporting, government policy, and innovative technology united under the Why Summits Future of Pharmacovigilance World Tour
key information
- Location: Embassy Suites by Hilton San Diego La Jolla 4550 La Jolla Village Drive, San Diego, USA
- Part of the Pharmacovigilance World Tour
- December 9-10, 2025
- 9:00 - 17:30 Local Time
What to expect
AI is already used in pharmacovigilance, but discussions often remain surface-level. As validated tools emerge, the focus shifts from if to how – gaining competitive advantage, ensuring transparency, and extracting value from new technologies. Regulators like EMA and FDA offer guidance, yet challenges persist around validating learning systems, justifying AI-driven signals, and shaping regulations.
AI is also changing PV roles, requiring new skills and workforce retraining. Ethical concerns like bias and underrepresentation must be addressed. We invite you to explore these critical issues at the 3rd AMERICA DRUG SAFETY & AI 2025.
Main takeaways
- Enterprise-Level AI Strategies
- Cross-Departmental Data Integration for End-to-End Signal Detection
- Validation Frameworks for Adaptive AI/ML Models
- Regulatory Readiness for AI Outputs in Inspection Scenarios
- Digital Infrastructure for Scalable PV Automation
- Risk-Based Automation of ICSRs
- AI & RWE
- Cross-Validation Between Human and AI Decisions
- Strategies For AI Into Existing PV Frameworks
- Integration of AI Across Multi-Vendor PV Ecosystems
- Training and Upskilling the Legacy Workforce: Organizational Change Management
- Global Regulatory And Compliance Harmonization
- Harmonizing Global Data Standards for AI
- AI Governance Models for Safety Committees
BENEFITS OF ATTENDING
- Forward-Looking Insights: Discover the latest trends, challenges, and advancements in pharmacovigilance from world-renowned industry leaders. Prepare for the future of drug safety with actionable strategies.
- Unparalleled Networking: Build connections with senior executives, regulatory specialists, and industry pioneers. Expand your professional network and collaborate with like-minded experts to drive innovation.
- Comprehensive Engagement: Participate in interactive discussions and hands-on sessions tackling key issues like emerging technologies, regulatory changes, and operational excellence, all led by top professionals.
- Global Expertise: Gain a worldwide perspective on the pharmacovigilance landscape, with insights into international regulations, diverse market environments, and strategies for effective global collaboration.
- Knowledge Exchange: Share experiences, learn best practices, and explore cutting-edge solutions to enhance your organization’s safety and compliance frameworks.
Target audience breakdown:
- Drug safety & Pharmacovigilance executives
- Heads of global safety programs
- AI, ML and LLM
- Digitalisation
- Data
- Innovation
- Quantitative Analysis
- QPPVs
- Benefit-Risk assessment management
- Medical affairs management
- Patient safety management
- Compliance specialists
- Post-market researchers
- PV auditors
- Regulatory affairs directors
- Compliance specialists
- Pharma IT management
- Safety consultants
Summit Aligned with the 7 I's:
- Intelligence: Insights from senior stakeholders with expertise in drug safety
- Ideas: Exploring emerging trends and opportunities
- Interaction: Benchmarking the best strategies in the industry
- Inspiration: Discovering new approaches and how to leverage them
- Innovation: Enhancing the effectiveness of PV organizations
- Implementation: Turning plans into impactful actions
- Improvement: Striving for excellence in pharmacovigilance
Elevate Your PV Game:
Mastering the 5 W’s
Who, What, When, Where, and Why are the cornerstones of effective process management and continuous improvement. Asking the right questions leads to meaningful answers—enabling you to set up processes with precision and drive greater effectiveness.
At our summit, dive into HOW to turn these foundational elements into actionable strategies that deliver measurable results. Learn. Innovate. Lead.
Event Speakers
Jean Redmond
Chief Operating Officer
Biologit
Tarak Thakker
Head of Safety Systems - Director Digital PV and Decision Support
BeiGene
Alok Singh
Global AI Product Manager, Analytics & Generating Insights - Product Development Informatics
Roche
Sudhir Shandilya
Director, Digital Delivery & Operations
Sanofi
Monica Jain
Director, R&D Data Science
J&J Innovative Medicine
Shruti Vij
Digital Transformation Lead
Takeda
Slava Akmaev
Chief AI Officer, Interim Chief Operating Officer
BPGBio
Anupam Aich
Domain Lead, Product Definition, Digital Pathology Clinical AI/ML Algorithms SaMD
Roche
Bahareh Kilcoyne
R&D Quality Data Scientist
J&J
Garrett Manasco
Associate Director, Clinical Artificial Intelligence
AbbVie
Event Partners
GOLD PARTNER
GOLD PARTNER
At Alwis Group, we’re pioneering AI-driven solutions for the healthcare and pharmaceutical industries. Our innovative tools are transforming pharmacovigilance, enhancing drug safety monitoring, and streamlining regulatory compliance. Our suite of products includes:
- ReTrans Enterprise: AI-powered literature surveillance
- ReTrans Extension: Browser plugin for real-time safety data analysis
- ScoMed: Intelligent medical literature scoring * ZiNex: Advanced medical document processing
- ZiQuel: AI-driven quality complaint management
- ZiTrack: Smart inbound receipt management
We’re committed to improving patient safety and operational efficiency through cutting-edge technology. Our solutions reduce costs, minimize errors, and accelerate processes, allowing healthcare professionals to focus on what matters most – patient care.
silver partner
Biologit delivers advanced active safety surveillance solutions for the life sciences sector, addressing human and veterinary pharmacovigilance, cosmetovigilance, nutravigilance, and materiovigilance. Biologit MLM-AI is a state-of-the-art platform for monitoring scientific literature to identify adverse events and emerging risks throughout a product’s lifecycle, from clinical development to post-marketing. Designed for teams of all sizes, it combines a flexible workflow with a unified global and local scientific database, enhanced by unique AI-driven screening and productivity tools. These features enable fast, accurate, and fully traceable results for all safety surveillance needs. Biologit Database is a robust, continuously updated repository of scientific literature, optimised for compliant regulatory searches. It integrates global and regional sources into an intuitive interface, delivering high-quality results for monitoring adverse events and potential risks. With over 65 million entries and 40,000 new articles added daily from 120,000 journals across 170+ countries, it ensures comprehensive coverage aligned with FDA, EMA GVP and global standards. Biologit provides a full suite of pharmacovigilance services, including Qualified Person for Pharmacovigilance (QPPV) and Responsible Person for Pharmacovigilance (RPPV) support in clinical trials.
media partner
The REMS Industry Consortium (RIC) is designed for REMS Professionals who are seeking best practices and opportunities to advance patient safety. RIC provides an avenue for leaders to build intellectual capital, leadership, and strategic resources necessary for innovation.
RIC is THE collective industry voice that works directly with the FDA to find ways to cut down the approval time for REMS innovation. By joining RIC, you can gain knowledge, experience, and professional affiliations that will put you at the forefront of REMS industry advancements.
Industry Pioneers Attending From
Testimonials
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REGISTRATION
PHARMA & BIOTECH
Ticket | December 9-10, 2025-
Access to all conference sessions
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Access to all networking activities during the conference
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Conference materials
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Coffee breaks with snacks and refreshments
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Networking lunch
SOLUTION-PROVIDERS & VENDORS
Ticket | December 9-10, 2025-
Access to all conference sessions
-
Access to all networking activities during the conference
-
Conference materials
-
Coffee breaks with snacks and refreshments
-
Networking lunch
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