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Conference Overview
Pharmacovigilance UK & EU 2026: Core Focus Areas
“As the pharmacovigilance landscape shifts toward an AI-integrated future, staying ahead of regulatory and technological curves is critical. Our 2026 agenda is strategically designed to address the core pillars of modern drug safety, providing you with actionable blueprints for excellence.”
From Compliance to Intelligence
Move beyond traditional reporting toward a predictive, AI-driven pharmacovigilance model that anticipates risks before they emerge.
AI & Automation in Action
Explore how AI Agents are transforming safety operations, from medical assessment to assisted aggregate report writing.
Regulatory Mastery
Engage directly on evolving global requirements, including EMA’s Post Authorization Safety Studies and modern RMP/REMS strategies.
Real-World Evidence (RWE)
Learn how to harness RWD to answer critical regulatory questions and improve structured benefit-risk assessments.
Patient-Centric Safety
Shift the focus to the next generation of drug safety by integrating the patient voice and fostering trust across the healthcare ecosystem.
Advanced Signal Detection
Discover cutting-edge methodologies for quality and signal detection to ensure robust safety surveillance in an increasingly complex data landscape.
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The Global Standard in Drug Safety Excellence
Building on a prestigious legacy of 40 successful global summits, the 40th Pharmacovigilance UK & EU 2026 arrives at a critical turning point for the industry. With the global drug safety software market projected to exceed $350M by 2030, the shift toward digital transformation and AI-driven reporting is no longer optional—it is a regulatory requirement.
This year, we unite a high-level ecosystem of Pharmaceutical, Biotech, and Regulatory stakeholders in Boston to dismantle silos and solve the most pressing challenges in the drug safety value chain. From navigating stringent EMA updates to mastering automation in PV, this forum provides the strategic intelligence and cross-functional collaboration needed to thrive in an increasingly complex global landscape.
Speakers
Attendees
round tables
Hours of High Value Networking
OUR ATTENDEES
Trusted by Industry Leaders Worldwide
REGISTER ATTEND LEARN NETWORK SUCCEED
5 reasons to attend the events
"In an era of rapid digital transformation and tightening global regulations, staying informed is no longer enough—you need a blueprint for action. Here is why the 41st Pharmacovigilance USA summit is the must-attend event for drug safety leaders in 2026."
Learn from the Elite
Access exclusive insights from senior leaders at Pfizer, Moderna, BMS, and GSK.
Master AI Innovation
Gain a technical edge with deep dives into AI Agents and Automation transforming PV operations.
Navigate Global Regulations
Stay compliant with expert-led sessions on the latest RMP, REMS, and EMA requirements.
Solve Real-World Challenges
Move beyond passive listening with interactive Roundtable Series designed for peer-to-peer problem-solving.
Elite Networking
Build high-value partnerships with a niche global audience in the heart of the Boston
Meet Our Expert Speakers
Industry leaders, regulators, and innovators sharing insights that are shaping the future of global healthcare and pharmacovigilance
OUR EVENT SCHEDULE
08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues.
09:15 – Opening Remarks / Welcome Address
09:30 – Chairperson opening remarks
PAV RISHIRAJ
Director, Pharmacovigilance & UK QPPV | ABPI PV Expert
Chair, Ipsen
BEYOND COMPLIANCE
09:40 – Beyond compliance: How we can do more for patients in PV
Patient voices in PV are still underutilized. We can move beyond compliance and do our best to make safety truly patient-centered.
This presentation will cover the current state, why it matters to include patient voices and how we can do more and move
from “checking the box” to doing our best for patients.
BEGUM BENLI PEKER
Head of Patient Safety EU Hub, Bristol-Myers Squibb
SAFETY
10:20 – Safety monitoring in clinical studies
- Proactive monitoring
- Timely detection and management of safety issues
- Interaction & communication with stakeholders.
RUDI SCHEERLINCK
Safety Strategy Lead – Oncology, Healthcare Business of Merck
10:50 – Morning Coffee/Tea & Networking
11:20 – Agentic AI in Pharmacovigilance: From Task Automation to Unified Data Intelligence
This session examines the structural shift in pharmacovigilance from task automation toward bounded, coordinated agentic systems operating on unified data and knowledge foundations. Drawing on emerging architectural patterns, it outlines howdecision intelligence elevates insight,
context, and cross functional coherence across safety and regulatory domains.
JASON BRYANT
SVP, Product Management, AI, ArisGlobal
LATEST UPDATES & HOT TOPICS
11:50 – Keynote Panel Discussion: Pharmacovigilance: Innovations, Challenges & Global Best Practices - Best practices & the way forward
Moderator
RUDI SCHEERLINCK
Safety Strategy Lead – Oncology
Healthcare Business of Merck
Panellists
REMCO M. DIAB
Global Head of PV, Science and Medical Affairs,
Former Sanofi
MARIJA SIMIC
Director Medical Safety Team Lead, Global Patient Safety
Sandoz
LEONARDO PEREIRA
Clinical Safety Director,
Roche
RACHEL MCDERMOTT
Senior Safety physician
Shionogi Europe
12:50 – Networking luncheon
PATIENT CENTRIC PV
13:50 – Panel Discussion – Patient-Centric PV: Elevating Drug Safety through Engagement. Making drug safety monitoring more proactive, data-driven, and human-centered
Moderator
PAV RISHIRAJ
Director, Pharmacovigilance & UK QPPV | ABPI PV Expert
Chair
Ipsen
Panellists
ABIDALI FAZAL
Safety Science Director,
Roche
SUMIT MUNJAL
Global Head of Medical Safety
Otsuka Pharmaceuticals
PUNAM KUMARI
Founder & MD,
Biovance Solutions
SANDY EISEN
Chief Medical Officer
CNS Consult
14:50 – Designing PV Systems for Humans and Agentic AI: A Risk-Based Path from HITL to HOTL
- Responsible system design for agentic AI in regulated Pharmacovigilance.
- The talk will outline a risk-based, regulatory-aligned approach to designing hybrid systems where humans and agentic AI are treated as equal system actors, with built-in explainability, auditability, fairness in line with CIOMS principles, and continuous model evaluation and replaceability.
MALIN KREITZ
Director of European Operations
Ultragenic Research and Technologies
15:10 – Afternoon Tea/Coffee
15:40 – Topic TBC
Speaker TBC
16:10 - Panel Discussion – The Evolving Era of PV Outsourcing: Recent Developments, Innovations and Best Practices
Moderator
PAV RISHIRAJ
Director, Pharmacovigilance & UK QPPV | ABPI PV Expert
Chair,
Ipsen
Panellists
LEONA HOUGHTON
Vice President, Global Safety (Ex-US),
Mundipharma
ZINA SADEQ
Director, Regional PV & Alliance Management, UK QPPV,
Amicus Therapeutics
PHILLIP EICHORN
Global Head of Drug Safety
Amryt Pharma
GURPREET SINGH
Vice President, Managing Director Integrated Safety,
IQVIA
GAYATHRI SUBBURAMAN
Senior Director, Global Safety Lead,
Menarini Stemline
HOWARD ABROMS
VP – Global Business Development,
Soterius
17:00 – Closing remarks by chairperson and End of day 01 conference
17:10 – Networking Drinks
08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues.
09:10 – Chairperson opening remarks
PAV RISHIRAJ
Director, Pharmacovigilance & UK QPPV | ABPI PV Expert
Chair, Ipsen
PV FOR FUTURE
09:20 – Beyond the Algorithm – The Human-AI Partnership in Pharmacovigilance
- Examines common anxieties about AI replacing human roles in pharmacovigilance and reframes these concerns to highlight new opportunities.
- Demonstrates how rekindling childlike curiosity and creativity in adult professionals can happen.
- Discusses practical approaches for building transparent, accountable processes when integrating AI into safety practices.
- Emphasizes the irreplaceable value of human judgement, empathy, and imagination alongside evolving AI technologies.
SABINE POLTERMANN
Head of Country Patient Safety Switzerland, Bristol-Myers Squibb
AUDITS & INSPECTIONS
09:50 – Panel Discussion - Plan, Develop & Implement the PV Audit strategy plan. PV Inspection readiness: What to expect? How ready can we be?
Moderator
MIJAL CHAVDA
Senior Director, Global Head of GxP Inspections & GVP Quality, Kyowa Kirin
Panellists
KARSTEN LOLLIKE
Scientific VP, Deputy QPPV, Global Patient Safety, Novo Nordisk
TEA BABIC
Director, PV Audits & Inspections, Teva
CHRISTIAN MUHL
Senior Director Compliance, GSK
HUMAIRA QURESHI
Chief Operating Officer, Arriello
10:30 - Planning and Managing Audits and Inspections- A service provider viewpoint
With the evolution of Pharmacovigilance through upskilling and restructuring and accelerated geo- expansion , how have Service Providers needed to adapt.
What should good look like now ? What is the role of technology in Audit Management and how is the demand in local, regional and global representation being managed
HUMAIRA QURESHI
Chief Operating Officer, Arriello
11:00 – Morning Coffee/Tea & Discussion
RISK MANAGEMENT & PLANNING
11:30 – Keynote Panel Discussion: Benefit-Risk Excellence: Innovative Approaches to Risk Management
Moderator
MIRCEA CIUCA
Independent PV Consultant / International PV Expert (Former Global Head Medical Safety, Organon)
Panellists
JEAN-MARC HAUSLER
Global Head of International Patient Safety, F. Hoffmann-La Roche
CHETAN SHATAPATHY
Executive Director & Head, ADC Group, Patient Safety Oncology, AstraZeneca
JOHN SOLOMON
Former Head of Pharmacovigilance - UK & Ireland, Sanofi
PETAR GJORGIEV
Global Patient Safety Lead, Regeneron
COMBINATION PRODUCTS
12:20 – Combination Products: Important Considerations for Patient Safety
- Medical Device Vigilance vs Pharmacovigilance
- Design Control
- Risk Management
JUDY BARRETTO
Senior Director, Virology TA, Patient Safety, Gilead Sciences
RWD / RWE
13:40 – Panel Discussion: Harnessing RWD & RWE: Transforming the Future of Pharmacovigilance
Moderator
SANJEEV SRIVASTAV
Signal Management Lead, BioNTech
Panellists
SHIKTA DAS
Scientific Lead Real World Evidence, Oncology, AstraZeneca
GAYATHRI SUBBURAMAN
Senior Director, Global Safety Lead, Menarini Stemline
PAV RISHIRAJ
Director, Pharmacovigilance & UK QPPV | ABPI PV Expert Chair, Ipsen
MAYUR PATEL
Head of Regulatory, Quality and Compliance| R&D Leader, PA Consulting
REGULATORY
14:20 – Harmonizing Local PV Activity to Improve Efficiency” with the accent on non_EU Countries (Balkan)
MARJAN DZEPAROSKI
Head of Regulatory Affairs, Drug Safety & Intelectual Property, Bionika Pharmaceuticals
14:40 – Panel Discussion: Regulatory Synergy in PV: Challenges, Opportunities & the Road Ahead
Moderator
PAV RISHIRAJ
Director, Pharmacovigilance & UK QPPV | ABPI PV Expert Chair, Ipsen
Panellists
STEPHANIE MILLICAN
Deputy Director BRE II, MHRA
MICHAEL BEAN
Senior Director, Regulatory Compliance, Johnson & Johnson
CALVIN JOHNSON
Vice President, International Patient Safety, Bristol-Myers Squibb
TERESA SARAGOCA
Director, Regulatory Affairs & Technical Manager, ITALFARMACO
15:30 – Chairperson’s closing remarks
15:40 – Evening Tea/Coffee and end of the conference
Our Partners
“We extend our sincere gratitude to the following organizations for their vital role in advancing the future of global drug safety. Their generous support, technical expertise, and dedication are the driving force behind the success of the 41st Pharmacovigilance USA 2026 summit. Together, we are fostering the innovation and collaboration needed to safeguard patients worldwide.”
Title Partner
Key Partners
Associate Partners
Promotional Literature Distribution
Event Venue
Sheraton Skyline Hotel London Heathrow
London
UK
+44 20 8759 2535
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Plot No – 07 – 2nd Floor
Ekambaram Industrial Estate
Alapakkam, Porur Chennai,
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