San Diego, USA

5th AMERICA 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

San Diego, USA

December 2-3, 2026
09:00 - 17:30 Local Time
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80+
participants
20+
speakers
2
days
10+
hours of networking
15+
roundtable discussions

What to expect

  • A Narrative Approach: This conference unfolds as a compelling story, showcasing personal experiences from exceptional professionals in Drug Safety and Pharmacovigilance, united by their mission to deliver safe medicines and improve global health. 
  • Timely Industry Insights: Gain expert perspectives on current challenges, from integrating disruptive technologies into rigid PV processes to managing priorities under tightening budgets, advancing methodologies for new therapies, and evolving signal detection strategies. 
  • Future-Focused Workforce: Explore how to build winning cross-functional teams, leverage the strengths of millennials, Gen Z, and industry veterans, and address the workforce needs of a forward-looking drug safety department. 
  • Comprehensive Topics: Engage in discussions on end-to-end PV Operations including Innovations, Evolving regulations, Harmonization, Optimizing Risk Management strategies, AI and Automation, Advanced Adverse Event Management, Patient Involvement, all with the shared mission of faster, safer, and sustainable patient care. 
  • Dynamic Networking Opportunities: Participate in visionary keynotes, best practice case studies, panel discussions, and both formal and informal networking sessions designed to foster meaningful partnerships and innovative solutions. 

Target audience

You will spend time with:

  • 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.

PAST 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

Event HIGHLIGHTS

case studies - keynotes OPTION 1
Visionary Keynotes
think tanks
In-Depth Panels
workshops
Strategic Roundtables
IMG_8156 2
Case Studies
DSC04792 5
Workshops
IMG_8199 2
Networking

Key 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

Everything you need to know about This event in one spot.

Check out our event overview and agenda and discover 5th AMERICA DRUG SAFETY & AI 2026

PAST AND PRESENT

Our valued partners

TESTIMONIALS

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
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
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
WhySummit’s Pharmacovigilance Conference in Boston exceeded expectations for all. As chair, I was impressed by the intimate scale and quality of interactions given how tricky it can be to strike the right balance of being large enough to bring together diverse perspectives and new connections, yet small enough to foster meaningful dialogue and substantive interactions. Both sponsors and attendees valued lively discussions that went beyond typical sessions (and without being overly ‘salesy’). Lubos and his team deserve credit for curating a program that was both informative and interactive, creating an environment where PV professionals could truly connect, share and learn from each other. Looking forward to next year!
Rated 5 out of 5
Andrew Mitchell
Chief Executive Officer, YEZA.ai

“Always Be curious

Why is this event right for you?

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. 

Event partners

Event registration

PHARMA & BIOTECH

REGISTRATION
$ 2349
  • 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
$ 3049
  • Access to all conference sessions
  • Access to all networking activities during the conference
  • Conference materials
  • Coffee breaks with snacks and refreshments
  • Networking lunch

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 5th AMERICA DRUG SAFETY & AI 2026.

Our Past Sponsors

upcoming Events

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Date: September 29-30, 2026
Location: Hyderabad
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5th AMERICA DRUG SAFETY & AI 2026
Date: December 2-3, 2026
Location: San Diego, USA
World’s greatest minds in drug safety, pharmacovigilance, data analysis, reporting, government policy, and innovative technology united under one roof.
4th American Drug Safety & Risk Management Conference 2026
Date: December 8-9, 2026
Location: Boston, USA
World’s greatest minds in drug safety, pharmacovigilance, data analysis, reporting, government policy, and innovative technology united under one roof.

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