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: San Diego, USA
- Part of the Pharmacovigilance World Tour
- December 9-10, 2025
- 9:00 - 17:30 Local Time
About the event
AI is already being used in pharmacovigilance, but the conversations around it are still surface-level in many circles. We need to dive deeper. As the technology matures, validated tools are being integrated — shifting the conversation from if we use AI to how we ensure transparency and interpretability, compliance, and appropriate human oversight.
Regulators like EMA, FDA, and PMDA are issuing guidance, yet key questions remain: how to validate learning systems, how to justify AI-driven signals, and howthe industry can engage in shaping regulatory expectations.
AI is also reshaping roles, and we need a dialogue about how to future-proof the PV workforce. PV professionals may move from manual processing to oversight and AI management, raising the need for workforce retraining and new skill sets.
Finally, bias and ethics cannot be ignored — AI trained on narrow datasets may miss critical signals. We must address algorithmic bias, ensure diverse representation, and develop robust ethical safeguards.
There’s many questions we need to discuss and answer surrounding this powerful technology, and we’d like to invite you to do so at our 3rd American Drug Safety & AI 2025, in San Diego.
Our flagship European PV event, here’s what you can expect:
PEER-TO-PEER NETWORKING
We specialize in providing peer-2-peer level networking experience for pharma & biotech professionals.
TOP-MANAGEMENT EXPERTISE
Bringing together the industry leaders in the field to share strategic perspectives and insights that are shaping the industry.
IN-DEPTH & INTERACTIVE
In contrast to loud, large-scale exhibitions, our events are setup to be discussion-driven for our participants to have meaningful conversations in a relaxed networking environment.
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
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
Past Event Speakers
Sean Green
Director, Safety Database Strategy and Analytics
Apellis Pharmaceuticals
Liz Grekas
Global Safety Lead
Novo Nordisk
Christine Hunter
Senior Consultant, Veeva Safety
Veeva Systems
Abdul Rahim
CEO & Founder
Alwis Solutions
Jamie Wilkins
Head- Risk Management Center of Excellence - Worldwide Safety
Pfizer
Nina Patel Lahanis
VP, Safety Data Management
PrimeVigilance
Jacqueline Gerena
Director Risk Management Strategy
Johnson & Johnson
Ashraf Youssef
Functional Area Lead, Patient Safety and Pharmacovigilance
Takeda Pharmaceuticals
Katarina Ilic
Expert Consultant
Mina Ebeid
Director Drug Safety and Pharmacovigilance Scientist
Genmab US, Inc
Past Event Partners
Industry Pioneers Attending From
Testimonials
Everything you need to know about this event in one spot.
Check out our event overview and agenda and discover this conference.
REGISTRATION
Conference
Ticket | December 9-10, 2025-
Access to All Conference Sessions of the 3rd America Drug Safety & AI 2025
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Access to Post Conference Networking
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Conference Materials
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Includes Coffee Breaks, Snacks and Refreshments, Seated Lunch
BECOME A PARTNER
OF this EVENT-
Present on the Main Stage
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Hold an exhibit at this event
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Showcase your Brand in Marketing Material
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Gain exposure through alternative partnership benefits
Past Event partners
Gold Partner
PrimeVigilance, an Ergomed Group company, was established in 2008 by Dr. Miroslav Reljanovic together with co-founder Dr. Elliot Brown. PrimeVigilance offers holistic, top quality, cost-effective, innovative clinical safety and PV services for pharmaceutical, biotechnology and medical device companies. Our leaders have an unrivalled reputation in the sector with a network of SMEs across the world. These include former senior regulators and consultants with expansive industry experience.
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
IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. IQVIA creates intelligent connections across all aspects of healthcare through its analytics, transformative technology, big data resources and extensive domain expertise. IQVIA Connected Intelligence™ delivers powerful insights with speed and agility — enabling customers to accelerate the clinical development and commercialization of innovative medical treatments that improve healthcare outcomes for patients. With approximately 86,000 employees, IQVIA conducts operations in more than 100 countries.
Silver Partner
4C Pharma Solutions is a comprehensive global healthcare solutions company specializing in end to end of Pharmacovigilance, Materiovigilance, Medical Information Call Center, Hosting, Regulatory Affairs, Medical Affairs, CDM & Staff Augmentation.
Silver Partner
Quark empowers the world’s largest pharmaceutical companies to automate the production of their highly regulated or complex documentation, so they can approve and publish it faster, and stay compliant. It enables them to accelerate regulatory approvals, release the bottlenecks around content collaboration, and get their drugs to market in record time.
Quark Publishing Platform (QPP) NextGen, the cloud-based, AI-powered component content management system (CCMS) with native XML-based structured authoring using Microsoft Word, helps pharmacovigilance teams centralize and simplify the processes involved in co-authoring and approving the PV system’s critical drug safety documentation. This starts with the master file (PSMF) and traverses through all aggregated and regulatory affairs reports, including development safety update reports (DSURs), periodic adverse drug experience reports (PADERs), periodic safety update reports (PSURs), periodic benefit-risk evaluation reports (PBRERs) and risk management plans (RMPs).
Powered by Microsoft Azure OpenAI and connected with wider content and business software ecosystems such as Veeva and ArisGlobal, QPP NextGen manages every stage of the authoring and review lifecycle from end to end. PV teams increase productivity and save time by easily writing, importing, formatting and publishing complex types of variable global content to omnichannel submission outputs using structured, XML component-based authoring workflows, stringently tracking workflows in real time, driving risk reduction and safeguarding compliance.
Silver Partner
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.
Silver Partner
Veeva is the global leader in cloud software for the life sciences industry. Committed to innovation, product excellence, and customer success, Veeva serves more than 1,000 customers, ranging from the world’s largest biopharmaceutical companies to emerging biotechs. As a Public Benefit Corporation, Veeva is committed to balancing the interests of all stakeholders, including customers, employees, shareholders, and the industries it serves.
Veeva Safety applications operate as a unified pharmacovigilance system on a single cloud platform to maximize operational efficiencies and improve patient safety. Automating data flow and simplifying PV processes, Veeva Safety delivers solutions to manage case processing from intake to submissions, PSMF, pharmacovigilance agreements, RMPs, aRMMS, and more. For more information, visit veeva.com/safety.
Strategic Partner
Veridat brings together a range of capabilities to help clients in response to a changing environment, reduce risk in response to growing complexity, and improve the processes and systems that protect brands, build trust, and add business value. Our flagship product, Bench™, is a lightweight, flexible, and easily implemented rendering data immutable and verifiable.
Registered participants will be offered a free trial of 5,000 transactions to create their own environment and experience, to be able to test & verify the increased effectiveness of data management value chain.
Panel Partner
Advity Research is a quality-driven Contract Research Organization (CRO) based in Hyderabad, India; led by experienced technocrats:
- Having extensive experience in the CRO industry
- Possess commendable expertise
- Committed to strengthening systems and teams while offering innovative approaches
With over 3 decades of experience in the CRO industry, Advity Research provides an integrated clinical research portfolio, which includes Bioavailability/Bioequivalence (BA/BE) services, clinical trial services, and pharmacovigilance services.
Pharmacovigilance Services:
We have consolidated our collective experience to provide comprehensive pharmacovigilance services. Our offerings include an experienced team, robust quality systems and processes, and a clear understanding of global pharmacovigilance requirements.
Currently, supporting Pharma & Biotech companies with products marketed across diverse geographic locations including the USA, UK, EU, Australia, and Canada. Our solutions cover:
- Medical information call centre
- Literature search
- Database
- Signal Management
- Case processing to Aggregate reporting.
