2nd American Drug Safety Summit
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: Boston
- Part of the Pharmacovigilance World Tour
- October 1-2, 2025
- 9:00 - 17:30 Local Time
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.
Main takeaways
- Strengthening REMS & Risk Mitigation Strategies
- Tech Innovation: Digital Solutions for Risk Management
- Evolving REMS Programs & Regulatory Expectations
- Risk-Based Decision Making in Pharmacovigilance
- AI in REMS: The Future of Safety Monitoring
- Risk Communication & Stakeholder Collaboration
- Post-Market Risk Management Best Practices
- Future of REMS & Global Risk Management Regulations
- The Next Decade of REMS & Risk Management
- The Power of Cross-Functional Collaboration in PV
- Enhancing PV Operations with AI & Automation
- AI-Driven Signal Detection & Risk Prediction
- The Business Case for AI in Pharmacovigilance
- Optimizing Safety Signal Management through Collaboration
- The Role of Real-World Evidence
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:
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- Pharmacovigilance Executives
- Regulatory Affairs Professionals
- Quality Assurance Specialists
- Drug Safety Officers
- Clinical Research Leaders
- VPs, Global Heads and Senior Directors of:
- Drug Safety
- Pharmacovigilance
- Risk Management
- Signal Detection
- Regulatory & Compliance
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- Post-market research
- PV audit
- Digitization
- Automation
- Operations
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
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
5/5
I had the pleasure of attending an insightful panel discussion featuring Pav Rishiraj, Gurpreet Singh, John Solomon MD, and Rishi C.! The pragmatic discussions truly reflected ground realities, and the practical tips provided were invaluable. Kudos to the organiser Tomas Rendek Why Summits for the excellent choice of topics and for bringing together the experts to address the real-world challenges in utilizing real-world evidence for patient safety.
Sanjeev Srivastav
Signal Management Lead at BioNTech
5/5
My highlights were hearing from the industry PV & Safety leaders, including:
📚 the brilliant panel with IPSEN's Pav Rishiraj, Sanofi's John Solomon MD and CSL's Rishi C. who spoke about the importance of PV leaders to educate their colleagues and leadership on the "What" they do, and "Why" they do it, so the role of patient safety is appreciated beyond simply the "Police" of Pharma.
Souhail Debaghi
Director of Sales at TriNetX
5/5
What an excellent 2-day event connecting with friends and industry colleagues, old and new. There was plenty to digest, lots of learnings and take home messages whilst we shared best practices. Looking forward to the next one!
Nick Nikberg
Senior Safety Specialist, AstraZeneca
5/5
Thanks to the 9th Global Pharmacovigilance & RWE Forum speakers, particularly Michael von Forstner, Alexandru Barbarosie, MD, Arun Ravindran, MD, and Karen Cheng, for sharing their knowledge and experience. It was a great first Pharmacovigilance conference and a good chance to meet more like-minded people in the industry.
Cláudia Meneses
Senior Pharmacovigilance Officer at Sanofi
5/5
Finishing off Day 2 with my IQVIA colleague Gurpreet Singh taking part in an open plenary discussion about "collaborations with HCP's and utilising digital tools". I have thoroughly enjoyed the past 2 days of networking with my colleagues and industry professionals. Thank you to Why Summits & Tomas Rendek for wonderful organisation and to Erika Barbarosie for chairing the event! I look forward to Basel later in the year!
Lewis Atkinson
Director of Business Development for PV Drug Safety Technology at IQVIA
5/5
Absolutely a blast, thank you Tomas, Zuzana and Why Summits! There are a vast variety of topics, interesting and exicting conversations, insightful presentations about hashtag#patientsafety, hashtag#compliance, hashtag#signalmanagement and more. I’m humbled that I can be a part of this - unmatching educational experience.
Erika Barbarosie
Associate Director PV Compliance at Gilead Sciences
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 | October 1-2, 2025
$
2349
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Access to All Conference Sessions of the 2nd American Drug Safety Summit
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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
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