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: Wyndham Boston Beacon Hill 5 Blossom Street, Boston
- Part of the Pharmacovigilance World Tour
- October 16-17, 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.
Event Speakers
William Blumentals
Head of Pharmacoepidemiology, Specialty Care
Sanofi
Ankit Lodaya
Senior Director Pharmacovigilance
Beam Therapeutics
Ash Higgins
Senior Pharmacovigilance Scientist
Deciphera
Jean Redmond
Chief Operating Officer
Biologit
Asif Mahmood
Vice President, Head of Medical Safety & Pharmacovigilance
AskBio
Shobha Rani
Senior Manager R&D, Cognitive Automation and Analytics, Johnson & Johnson
Johnson & Johnson
Harsh Bhatt
Production & PV Supervisor
Apnar Pharma
Dr. Karthik Muthusamy
Senior Director, Head Expedited Safety Reporting
Bristol Myers Squibb
Deepa Venkataraman
Vice President, Head of Global Patient Safety and Pharmacovigilance
Corcept Therapeutics
Kyle Irwin
Director REMS & Risk Management
J&J Innovative Medicine
Event Partners
GOLD PARTNER
GOLD PARTNER
4C Pharma Solutions is established and operated by Physicians and Subject Matter Experts experienced in Clinical Research, Pharmacovigilance and Regulatory Affairs. It is one of the fastest growing global service provider organizations headquartered in the United States. The service spectrum spans Pharmacovigilance/Drug Safety, Devices, Biologics, Consumer Care products, Nutraceuticals & Cannabis products, Regulatory Affairs, Medical Writing, Argus Safety Database Hosting, Maintenance, Support and Training.
4C is focused on delivering quality services at an optimized cost to suit clients’ budget. We are ISO 9001 and 27001 certified with fully validated in-house Oracle Argus Safety installed on cloud for quick deployment and high availability. We provide quality support for Argus at drastically reduced costs facilitating companies to focus on R&D and other tasks without extensive technology overheads.
We have an exemplary team of healthcare and IT professionals, well-established facilities, processes and systems capable of providing end to end support in Dossiers (CTD/eCTD/NeeS) preparation, publishing, validation, submissions, Labeling, Artworks, Medical Information Call Center, Literature Search, Case Processing, Signal Detection, Aggregate Reports, Risk Management Plans, Pharmacovigilance SOPs preparation, System setup and Training. 4C team also has expertise on multiple safety and regulatory applications to accommodate any requirement.
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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