Barcelona, Spain
European Drug Safety & AI 2026
The world's greatest minds in drug safety, pharmacovigilance, emerging technologies and innovation strategy coming together to discuss the future of AI in PV, as part of our Pharmacovigilance World Tour
KEY INFORMATION
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 European Drug Safety & AI 2026.
Conference format
Our 2-day conference is tailored to support you in addressing key challenges at the intersection of pharmacovigilance and AI—whether it’s optimizing signal detection with limited resources, integrating AI into case processing, or ensuring compliance while adopting advanced automation in safety systems.
In addition to our trusted formats – Keynotes, Case Studies, and Panel Discussions – we are introducing new interactive sessions to deepen learning and real-world application:
Day 1
STRATEGIC ALIGNMENT & ENTERPRISE LEVEL AI REQUIREMENTS FOR PV SUCCESS
-
Integration with Corporate Vision: AI adoption in PV must align with overall R&D, regulatory, and safety strategy
-
Robust Data Infrastructure: Centralized, interoperable data lakes integrating safety, clinical, and real-world data (EHRs, social media, registries).
-
Seamless System Integration: Compatibility with legacy PV systems
-
Scalable Architecture: Cloud-based, modular systems capable of handling increasing data volume and complexity.
-
Vendor & Partner Ecosystem: Collaborative frameworks with AI vendors ensuring transparency, documentation, and audit readiness.
-
Human-in-the-Loop Oversight: Systems designed for augmented intelligence—supporting, not replacing, expert judgment.
Day 2
REAL WORLD USE CASE OF AI: MOVING FROM HYPE TO REALITY
-
AI-Powered Signal Detection & Prioritization
-
Literature Screening & Monitoring
-
Narrative Analysis & Medical Review Support
-
Quality, Compliance & Audit Readiness
-
Safety Integration Across Clinical & Post-Marketing Data
EVENT speakers
Ashish Dwivedi
Chief Customer Officer
Synapmed
Andrei Chitu
BD Consultant
Norwich Clinical Services (NCS)
Dr Rajeev Patil
MetatronicMind Technologies (MMT)
CEO
Dmytro Horilyk
CEO
DrugCard
Dimitris Zampatis
Director Product Patient Safety (DPPS)
Sandoz
Romain Clement
Co-founder & CEO
ArcaScience
Edgardo Miranda Head of International Medical Affairs
Head of International Medical Affairs
FAES Farma
Maha Lakshmi Elluri
Global Safety Director, EU/ EEA QPPV
Indivior
Event partners
GOLD SPONSOR
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.
GOLD SPONSOR
Norwich Clinical Services is a global CRO providing Pharmacovigilance, Clinical Research, Bioanalytical, and Training Services. Our facilities have been inspected by most global regulatory agencies such as EMA, FDA, MHRA, WHO, ANVISA, MOH Turkey, NPRA, and CDSCO India. And all our services are conducted in strict conformity with the latest GCP, GLP and 21 CFR (part 11) guidance. NCS’ full Pharmacovigilance, product surveillance and drug safety support services cover the entire product life cycle from development, through pre and post-marketing stages. NCS is a reliable partner for compliance and effectiveness of PV/surveillance systems and complex regulatory requirements.
GOLD SPONSOR
MetatronicMind Technologies is a software development company based in Bangalore, India. Our focus is AI-driven technology and solutions to industry-specific problems. We pride ourselves on our detail-oriented approach to software development, refining our products to meet industry requirements and provide solutions that enhance the capabilities of professionals within the domain. MMT would like to present LIAISE, an innovative Literature Automation and Segregation tool.
ROUND-TABLE SPONSOR
ArcaScience builds the first AI platform dedicated to benefit–risk assessment, streamlining work that used to take months into minutes. It delivers 10 to 100× more relevant, traceable insights, enabling pharmacovigilance teams to understand and act on the benefit–risk balance with confidence.
SILVER SPONSOR
DrugCard provides a cost-effective and regulatory compliant platform that automates pharmacovigilance — from global and local literature monitoring to regulatory tracking and case management. We help PV teams save time, stay compliant, and never miss a signal. Powered by AI, DrugCard transforms complex data into actionable insights, automates reporting and literature screening, and allows experts to focus on what matters most — strategic decisions and patient safety. Automated Local and Global Literature Monitoring Monitor both global databases like PubMed and local journals in one place. We already cover 104+ countries and 1800+ local journals, and counting. We add any journal you need — fast and without bureaucracy. No missed publications. No manual searches. Just faster, safer pharmacovigilance. AI-Powered Regulatory Intelligence Receive updates from global and local authorities in one centralized view — no more checking dozens of websites manually. DrugCard keeps your team informed on every regulatory change so you can act fast, stay compliant, and focus on what’s next — not on chasing updates. Adverse Event Database & Software Manage safety cases with an interface that feels intuitive, not overwhelming. Get the full “enterprise” functionality without the complexity, cost, or six months of training. Everything you need to collect, assess, and track adverse events efficiently — all in one secure, audit-ready platform. Pharmacovigilance Services Extend your in-house capabilities with our PV specialists. DrugCard combines automation with human expertise — from literature review and reporting to quality checks and documentation. You get precision, consistency, and compliance delivered by experts who understand your needs.
BRONZE SPONSOR
Vitrana is a leading pharmacovigilance technology company pioneering AI‑powered workflow automation to transform drug safety operations. Headquartered in the U.S. with operations in India and Japan, it is a trusted partner to eight of the top ten global pharmaceutical companies. Combining an innovative technology platform with deep domain expertise, Vitrana enables life sciences organizations to modernize and scale safety processes. Its vision extends beyond traditional pharmacovigilance toward proactive, evidence‑based safety management. As regulatory complexity and data volumes rise, Vitrana’s flexible, AI‑driven approach helps clients navigate industry transformation. Building on strong enterprise sales, the company is expanding through CRO and FSP partnerships to reach SMB pharma and accelerate international growth.
BRONZE SPONSOR
Synapmed is a science-led, AI-native, full-service CRO transforming drug safety, compliance, and clinical development across the product lifecycle. The organization supports programs from pre-clinical through post-marketing across 40+ countries, operating in 60+ languages, and spanning ten plus therapeutic and rare-disease areas. With ISO-certified quality systems and a unified, inspection-ready operating model, Synapmed integrates clinical operations, regulatory affairs, pharmacovigilance, medical affairs, real-world evidence, and market access within a single connected platform, ensuring end-to-end traceability, auditability, and regulatory compliance across all deliverables.
In parallel, Synapmed is pioneering the future of medical AI by contributing real-world, high-impact use cases to the training of one of the world’s most advanced large language models. We have recently supported a top-20 global pharmaceutical company in analyzing data from 50,000+ patients across 11 rare diseases, using AI to uncover treatment and biomarker patterns and enable up to 60% faster, data-driven decision-making.
Event HIGHLIGHTS
Visionary Keynotes
In-Depth Panels
Strategic Roundtables
Case Studies
Workshops
Networking
Key takeaways
Strategic Integration of AI in Pharmacovigilance
Explore how AI is redefining global drug safety strategies—from executive alignment and digital transformation to regulatory adaptation. Discussions emphasize readiness at the leadership level, long-term vision, and enterprise-wide deployment.
Real-World AI Applications Across the PV Lifecycle
Gain insights into practical AI implementations—from signal detection and ICSR triage to literature surveillance and risk management. The focus is on outcomes, performance metrics, and lessons learned.
Governance, Compliance & Regulatory Readiness
Tackle the growing need for robust AI governance frameworks in pharmacovigilance. Sessions cover ethical AI, global regulatory developments, liability, and vendor oversight in highly regulated environments.
Workforce, Change Management & Human-AI Collaboration
Prepare the pharmacovigilance workforce for an AI-powered future by emphasizing human oversight, digital fluency, and organizational transformation.
Enabling Technologies: Generative AI, RWE & Predictive Models
Explore how emerging technologies—like generative AI, in silico simulations, and real-world evidence—are shaping the future of safety decision-making.
Collaboration, Networking & Industry Alignment
Foster cross-functional collaboration and open dialogue through round-table discussions, panels, and networking sessions. These interactions aim to align stakeholders—from PV leaders and data scientists to regulators and vendors—on the future of AI in drug safety.
Everything you need to know about This event in one spot.
Check out our event overview and agenda and discover European Drug Safety & AI 2026
PAST AND PRESENT
Our valued partners
TESTIMONIALS
I thoroughly enjoyed the interactive and spontaneous discussions on key pharmacovigilance topics, ranging from Gen AI to PV regulatory frameworks. The conference brought together a focused group of PV professionals, providing ample opportunities to connect and network with like-minded individuals. Overall, it was a successful conference and met its objectives.
★★★★★ Rated 5 out of 5
Karthik Babu
Consumer Healthcare Global PV Operations Head, Sanofi
Participating in the American Drug Safety Summit was a truly rewarding experience. The energy in the room, the depth of conversations, and the shared commitment to transforming pharmacovigilance made it an inspiring and impactful event. I walked away with new perspectives, meaningful connections, and a strong sense of momentum for what’s ahead.
★★★★★ Rated 5 out of 5
Gigi Atalla
Vice President, Head of Global Drug Safety & Pharmacovigilance, Genmab
The conference fosters invaluable connections and drives meaningful collaboration, offering an engaging platform for dynamic interactions within Global Pharmacovigilance & Risk Management, exchange of ideas, and shared growth among participants to ensure patient safety and regulatory compliance.
★★★★★ Rated 5 out of 5
Kal Elhoregy, RPh., PA.
Senior Director, Global Risk Management, Amneal
I thoroughly enjoyed participating in the Why Summits pharmacovigilance conference. The topics were not only timely and relevant but also deeply engaging, sparking meaningful discussions. I especially appreciated the collaborative atmosphere, which created a great opportunity to connect with colleagues across the field and exchange valuable insights.
★★★★★ Rated 5 out of 5
Mina Ebeid
Director, Global Drug Safety, Genmab
The American Drug Safety Summit 2025 was a great event to learn from industry experts about the evolution of patient safety. It was very interesting to see how AI is being leveraged in data-intensive projects to improve patient outcomes. The introduction to the REMS Industry Consortium was a highlight, and their work is truly inspiring.
★★★★★ Rated 5 out of 5
Apoorva Anil Joshi
Senior Pharmacovigilance Product Scientist, Genentech
I want to express my gratitude to Lubos and the Why Summits team for a well-organized and informative Pharmacovigilance event. The comprehensive agenda, featuring a variety of expert presenters and engaging panel discussions, provided valuable insights and fostered productive networking. I’m eager to participate in future Why Summits events.
★★★★★ Rated 5 out of 5
Israel Bocanegra
Associate Director, Business Development, Pharmacovigilance Technology Solutions
Attending this year American Drug Safety Summit 2025 in Boston by Why Summits was an absolute discovery for me. Attendees were not numerous but they represented top-notch leaders from pharma industry in the EU and USA.
Discussions were so exciting and constructive – I enjoyed every moment of it. I am truly grateful to Jan, Lubos and Zuzana for such a smart planning of this important event.
★★★★★ Rated 5 out of 5
Maja Barac
Director, EU Qualified Person for PV, PharmaVigil
This event provided great opportunity to network with Industry peers & thought leaders and explore new ways of working. Especially in the new AI era; “on how Pharmacovigilence industry is progressing and how we need to adapt to the change”. Insights from presentations and panel discussions are adorable .
I left with great ideas and new connections in my network to collaborate with and grow further.
★★★★★ Rated 5 out of 5
Vasudev Sureddy
Executive Director & COO, ADVITY RESEARCH
Fabulous meeting today, Lubos. This is a fabulous opportunity for us to shape the future, not just that we can be the conduit to current advances, but we can go beyond that with our military grade solutions.
★★★★★ Rated 5 out of 5
Robert Huber
Co-Founder and Chief Product Officer, Veridat
“Always Be curious”
Why is this event right for you?
If you’re navigating the rapidly evolving intersection of pharmacovigilance and AI, this conference offers the clarity, expertise, and connections you need. Whether you’re exploring how to scale AI across safety operations, aligning with global regulations, or upskilling your team for a digital future—this event delivers real-world insights from those leading the change.
Event registration
PHARMA & BIOTECH
REGISTRATION
€
2399
-
Access to all conference sessions
-
Access to all networking activities during the conference
-
Conference materials
-
Coffee breaks with snacks and refreshments
-
Networking lunch
SOLUTION-PROVIDERS & VENDORS
REGISTRATION
€
3099
-
Access to all conference sessions
-
Access to all networking activities during the conference
-
Conference materials
-
Coffee breaks with snacks and refreshments
-
Networking lunch
BECOME A PARTNER
OF this EVENT-
Present on the Main Stage
-
Hold an exhibit at this event
-
Showcase your Brand in Marketing Material
-
Gain exposure through alternative partnership benefits
Position Your Brand Where PV & Emerging Technologies Take Shape.
Get in front of the teams that manage pharma’s biggest programs. Explore sponsorship and exhibition opportunities at European Drug Safety & AI 2026.
Our Past Sponsors
