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Conference Overview
Here is an overview of the 44th Pharmacovigilance UK & EU 2027 conference, highlighting six major areas focused on during the event:
The global pharmacovigilance market is rapidly evolving through digital transformation, changing regulatory frameworks, and an increased emphasis on patient-centric safety strategies. This event brings together leading pharmaceutical, biotechnology, and regulatory professionals to exchange practical insights and advance modern drug safety.
Market Trends
Navigating the Landscape Exploring emerging industry challenges, new opportunities, and what lies ahead for the global pharmacovigilance market.
Patient Safety
Patient-Centricity Putting patients at the center of every safety decision to capture real-world safety needs and experiences.
Audits & Inspections
Inspection Readiness Building robust, inspection-ready pharmacovigilance systems to ensure compliance and best practices.
Digitalisation & AI
Smart Technology Harnessing artificial intelligence, real-world evidence, and digital tools to transform safety intelligence and case processing.
Risk Management
Risk Minimisation Reimagining risk management strategies from initial identification to effective risk minimisation across the product lifecycle.
Regulatory Updates
Regulatory Compliance Navigating the evolving UK and EU regulatory landscape, international standards, and compliance expectations.
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Navigating the Future of Drug Safety
The global pharmacovigilance market is expanding rapidly, driven by increased regulatory scrutiny, complex biologics, and digital transformation. As the industry shifts from reactive compliance to proactive, predictive safety strategies, professionals face new opportunities and challenges in management and technology.
This premier event brings together leading pharmaceutical, biotechnology, CRO, and regulatory experts to exchange practical insights. Attendees will explore artificial intelligence, real-world evidence, risk minimization, and evolving UK and EU regulatory frameworks. Join us to connect with peers, discover innovative solutions, and collaborate on shaping a safer tomorrow for patients worldwide.
Speakers
Attendees
networking
Sessions
OUR ATTENDEES
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5 reasons to attend the events
The 44th Pharmacovigilance UK & EU 2027 summit brings together leading pharmaceutical, biotechnology, and regulatory professionals to examine critical advancements in drug safety. Attendees will explore digital transformation, artificial intelligence, and evolving compliance expectations to shape proactive safety strategies. Join industry peers to exchange practical insights and drive meaningful progress in patient safety.
Strategic Insights
Market Trends Navigate the changing pharmacovigilance landscape by understanding current industry challenges, emerging opportunities, and future directions.
Patient Focus
Patient-Centricity Learn how to place patients at the centre of every safety decision to better capture real-world safety needs and experiences.
Cutting-Edge Tech
Digital Transformation Discover how to harness artificial intelligence, real-world evidence, and automation to transform modern safety intelligence.
Regulatory Clarity
Compliance Standards Gain expert guidance on navigating the evolving UK and EU regulatory landscape, international standards, and compliance updates.
Peer Networking
Industry Collaboration Connect directly with pharmaceutical leaders, regulators, and solution providers during interactive roundtable discussions and networking receptions.
Meet Our Expert Speakers
OUR EVENT SCHEDULE
08:00 – Coffee and registration – An opportunity to meet and to network with your conference colleagues.
09:00 – Chairperson opening remarks
PAV RISHIRAJ
Celltrion
PV LANDSCAPE IN 2027
09:20 – Leading the Charge in Pharmacovigilance: Breaking Down Silos for Patient & Customer Safety
- Fostering Cross-Functional Collaboration: Unify safety, quality, regulatory affairs, clinical operations, and data science teams to dismantle departmental silos and streamline decision-making across the organization.
- Elevating Patient and Customer Safety: Transition from a reactive, compliance-driven framework to a proactive, holistic focus on patient and healthcare provider safety across the product lifecycle.
- Capitalizing on Industry Transformation: Leverage rapid innovations in combination products, digital health, and advanced analytics to position pharmacovigilance as a dynamic, forward-looking strategic partner.
- Driving Sustainable Organizational Culture: Cultivate an agile quality culture built on integrated governance, continuous cross-training, and seamless data sharing to safeguard patient trust and drive long-term value.
KHAUDEJA BANO
Roche - Genentech
VINEET SINGH
CSL Behring
INSPECTION READINESS IN 2027
10:00 - FIH study- safety considerations, including role of AI
Keynote Themes
• The Impact of Syndicated Data Lag: How delays between payer change and field visibility can create uncertainty, reduce confidence, and affect decision-making
• Data Availability vs. Data Usability: Why having more information does not necessarily produce better field execution
• The Cost of Inconsistent Information: How multiple sources, conflicting answers, and fragmented systems contribute to field uncertainty
• Confidence as a Driver of Adoption: Exploring the relationship between trust, utilization, and execution effectiveness
• The Future of Market Access Intelligence: Why leading organizations are shifting their focus from information volume to information credibility, accessibility, and actionability
TANUJA HALADY
Merck KGaA
INSPECTION READINESS IN 2027
10:30 – Topic TBC
Speaker TBC, Aris Global
Keynote Themes
• The Impact of Syndicated Data Lag: How delays between payer change and field visibility can create uncertainty, reduce confidence, and affect decision-making
• Data Availability vs. Data Usability: Why having more information does not necessarily produce better field execution
• The Cost of Inconsistent Information: How multiple sources, conflicting answers, and fragmented systems contribute to field uncertainty
• Confidence as a Driver of Adoption: Exploring the relationship between trust, utilization, and execution effectiveness
• The Future of Market Access Intelligence: Why leading organizations are shifting their focus from information volume to information credibility, accessibility, and actionability
TANUJA HALADY
Merck KGaA
11:00 – Morning Coffee/Tea & Networking
PATIENT SAFETY / CENTRICITY
11:30– Keynote Panel Discussion – From Adverse Event Reporting to Meaningful Patient Safety: Putting the Patient at the Centre of Modern Pharmacovigilance
How can UK and EU pharmacovigilance organisations move beyond compliance-driven reporting towards safety strategies that better capture patient experiences, perspectives and real-world safety needs?
Moderator
PAV RISHIRAJ
Celltrion
Panellists
FABIO DE GREGORIO
Ipsen
TANUJA HALADY
Merck KGaA
PETAR GJORGIEV
Regeneron
ATTILA OLAH
Gedeon Richter
NAOMI LITCHFIELD
Bionical Emas
RWD / RWE
12:20 – Solution Provider Presentation
- Evaluating the traditional view of market access and what contract success means
- Assess what are payers telling us about the future of Pharma contracting
- Quantifying the gaps in the Patient Journey why those gaps are larger than most teams believe
- Understanding where and why marketing, forecasting, payer contracting, and patient services break down
- A proposed model & expanded role for Market Access: What it would take to make it happen, and the impact it would have on process, product, and patient
JERRY SMITH
D2 Solutions
12:50 – Networking luncheon
TECHNOLOGY / DIGITALISATION/ AI / RWE RWD
13:50 – Panel Discussion – The Digital Pharmacovigilance Revolution: Harnessing AI, RWE & RWD to Transform Safety Intelligence Across the UK and EU
How will AI, real-world evidence, real-world data and emerging digital sources reshape safety assessment and decision-making, while ensuring data quality, transparency, validation and appropriate human oversight?
Moderator
SANJEEV SRIVASTAV
BioNTech
Panellists
ESRAA A. ZOUBI
Jordan FDA
CHETAN SHATAPATHY
AstraZeneca
SEBASTIAN KLOSS
Menarini Group
ARIJIT PATRA
UCB
SHIKTA DAS
AstraZeneca
OUTSOURCING
14:40 – Panel Discussion – The Outsourced PV Model Under the Microscope: Strengthening Oversight, Accountability & Quality Across Global Vendor Networks
How can MAHs maintain effective governance, quality and accountability when critical PV activities are increasingly distributed across CROs, vendors, affiliates and specialist service providers?
Moderator
YVONNE NANCIU
Bayer
Panellists
ZINA SADEQ
Amicus Therapeutics
RISHI CHOPRA
CSL Behring
GIOVANNI FURLAN
Sandoz
Gurpreet Singh
pivot path
15:30 – Afternoon Tea/Coffee
COLLABRATIVE BREAKOUT SESSIONS
16:00 – The round table series
We have curated 6 distinct roundtable topics, each led by an 2 table speakers. The session is designed for maximum cross-pollination of ideas.
The Selection: Look at the table numbers and topics listed below. Choose the theme most relevant to your interest.
The Format: Each table will host a focused, 60-minute deep dive.
The Flow: Take a seat at your first chosen table. The table speakers will kick off with a brief prompt followed by an open-floor discussion. You have the option to stay put to go deeper or rotate to a different table to gain a new perspective.
Participation Guidelines
Lean In: These sessions thrive on your input. If you are comfortable, feel free to discuss on your “work-in-progress” thoughts.
Keep it Brief: With limited time, aim for “concise contributions” to ensure everyone at the table has a voice.
Connect: Keep your business cards or digital QR codes ready—these tables are where the best partnerships begin.
Note: Seating is first-come, first-served. If a table is full, we encourage you to explore your second-choice topic—you might find an unexpected insight!
JAY WEAVER
PANTHERx Rare Pharmacy
Table 1 – Technology & Innovation
Transforming Pharmacovigilance Through Technology: AI, Analytics, and Real-World Evidence
Speakers
Speaker TBC
Aris Global
SHAANTANU DONDE
Viatris
Table 2 – Audits & Inspections
Audit-Ready Pharmacovigilance: Inspection Preparedness, Compliance, and Best Practices
Speakers
MIJAL CHAVDA
Kyowa Kirin
SMRUTTI KOTHARI
BioMarin Pharmaceutical
MARIANNE MOUNIR
Bayer
Table 3 – Outsourcing & Collaboration
Collaborative Pharmacovigilance: Optimizing Partnerships Across Sponsors, CROs, Sites, and Patients
Speakers
JOHN POUSTIE
Haleon
SMRUTTI KOTHARI
BioMarin Pharmaceutical
MARIANNE MOUNIR
Bayer
Table 4 – Regulatory Landscape
Navigating Global PV Regulations: Updates, Expectations, and Future Directions
Speakers
SYED ZAFEERUDDIN
Julphar
SMRUTTI KOTHARI
BioMarin Pharmaceutical
MARIANNE MOUNIR
Bayer
Table 5 – Risk Management (RMP / REMS)
Next-Generation Risk Management: Evolving RMP Strategies for Patient Safety
Speakers
SYED ZAFEERUDDIN
Julphar
SMRUTTI KOTHARI
BioMarin Pharmaceutical
MARIANNE MOUNIR
Bayer
Table 6 – Quality, Safety & Signal Detection
Ensuring Quality and Safety in PV: Advanced Approaches to Signal Detection and Risk Evaluation
Speakers
LUIZ LIMA
Ipsen
GALINA CORDEROV
JSC Farmak
HEINZ WEIDENTHALER
BioNTech
15:00 – Beyond Coverage: Emerging Barriers to Cell and Gene Therapy Access.
This presentation examines how employer benefit exclusions, referral and treatment-center constraints, evolving rare-disease evidence standards, and 340B reform could impede patient access to cell and gene therapies. It outlines why manufacturers must address access as an end-to-end delivery and financing challenge, not solely a payer coverage issue.
MANNAT SHARMA
Clarivate
15:20 - Presenter, Coverage Is Not Access: Closing the Last Mile to Patient Start and Persistence
This presentation examines how employer benefit exclusions, referral and treatment-center constraints, evolving rare-disease evidence standards, and 340B reform could impede patient access to cell and gene therapies. It outlines why manufacturers must address access as an end-to-end delivery and financing challenge, not solely a payer coverage issue.
Melissa Dragic Swoope
TROJE Health Strategies
COLLABRATIVE BREAKOUT SESSIONS
16:00 – The round table series
Chairperson for all tables
PETER BARSCHDORFF
Deallus
We have curated 6 distinct roundtable topics, each led by 2 table speakers. The session is designed for maximum cross-pollination of ideas.
The Selection: Look at the table numbers and topics listed below. Choose the theme most relevant to your interest.
The Format: Each table will host a focused, 60 minute-deep dive.
The Flow: Take a seat at your first chosen table. The table speakers will kick off with a brief prompt followed by an open-floor discussion. You have the option to stay put to go deeper or rotate to a different table to gain a new perspective.
Participation Guidelines
Lean In: These sessions thrive on your input. If you are comfortable,
feel free to discuss on your “work-in-progress” thoughts.
Keep it Brief: With limited time, aim for “concise contributions” to ensure everyone at the table has a voice.
Connect: Keep your business cards or digital QR codes ready—these tables are where the best partnerships begin.
Note: Seating is first-come, first-served. If a table is full, we encourage you to explore your second-choice topic—you might find an unexpected insight!
Table 2 – Market Access & Reimbursement Pathways
HTA strategy and submissions. Payer negotiation approaches. Early access programs. Overcoming access barriers
Table Speakers / Leaders
HANNAH JAVED
Johnson and Johnson
DHARMESH VORA
Abbott
Table 3 – Innovative Contracting & Value-Based
Agreements
How are they negotiated, deployed & operationalised? how terms should be negotiated?
Table Speakers / Leaders
OMAR ALI
Verpora
Table 4 – Government Contracting, Pricing and Reporting
State Drug Price Transparency & Reporting: State-By-State Review of Legal Requirements and Operational Challenges
Table Speakers / Leaders
ROSALIND DAVIS
CSL Vifor
Table 5 – Key Regulatory and Legal Developments
IRA implementation and litigation. Discussion of government efforts and what is the way forward?
Table Speakers / Leaders
14:50 - Re-imagining Dossier Authoring: From Manual Compilation to AI-Assisted Authoring and Lifecycle Management
- AI-driven automation in dossier creation: Transition from time-consuming manual compilation to intelligent automation where AI tools structure, draft, and validate regulatory dossiers using pre-designed templates as per ICH guidelines and real-time data processing.
- Enhanced compliance and efficiency: AI-assisted authoring ensures alignment with global regulatory standards (e.g., EMA, USFDA, CDSCO) by auto-updating changes in guidance and improving accuracy, traceability, and submission timelines.
- Lifecycle intelligence and version management: Integrating AI into the dossier lifecycle enables continuous monitoring, smart version control, and predictive updates across product changes, fostering a fully connected regulatory ecosystem.
MANASA KASIVAJJULA
CEO and Co-Founder
DeepForrest.ai (A CtrlS Company)
17:00 – Closing remarks by chairperson and End of day 01 conference
17:15 – 18:30 – Networking Drinks Reception
08:00 – Coffee and registration – An opportunity to meet and to network with your conference colleagues.
PETER BARSCHDORFF
Deallus
09:20 – Welcome Address & Opening Remarks
08:50 – Chairperson opening remarks
PAV RISHIRAJ
Celltrion
ICH E2D(R1)
09:00 – The Future of Individual Case Safety Reports: Evolving Data Sources, Reporting Standards & Data Quality
- Implementing the latest ICH E2D(R1) requirements
- Managing emerging sources of individual safety reports
- Improving ICSR data quality and completeness
- Addressing organised data collection systems
- Strengthening reporting processes across UK and EU markets
- Preparing PV teams for evolving reporting expectations
BOXIONG TANG
Ascentage Pharma
SAFETY & SIGNAL DETECTION
09:30 – Panel Discussion - From Signals to Safety Decisions: Advancing Signal Detection, Evaluation & Emerging Risk Identification in Modern Pharmacovigilance
How can PV teams improve the identification, validation and evaluation of potential safety signals while distinguishing genuine emerging risks from data noise across increasingly complex safety datasets?
Moderator
JUDY BARRETTO
Gilead Sciences
Panellists
SIMON ASHWORTH
MENARINI Group
REMCO DIAB
Cheplapharm
VALENTINA MANCINI
Shionogi Europe
ZOE CONWAY
Roche
REMCO DIAB
Cheplapharm
VALENTINA MANCINI
Shionogi Europe
10:20 – Solution Provider Presentation
JAMIE GROSSMAN
Bayer
10:40 – Morning Coffee/Tea & Discussion
RISK MANAGEMENT & PLANNING
11:10 – Keynote Panel Discussion - From Risk Identification to Risk Minimisation: Reimagining Pharmacovigilance Risk Management Across the Product Lifecycle
How can organisations strengthen proactive risk identification, RMP strategies, risk minimisation measures and post-authorisation safety activities to anticipate emerging risks rather than simply respond to them?
Moderator
OMAR ALI
Verpora
Panellists
SUMIT MUNJAL
Otsuka Pharmaceuticals
SABINE POLTERMANN
Bristol-Myers Squibb
KRUPA PATEL
GSK
12:00 – Solution Provider Presentation
■ The Theory Behind Drug Pricing
■ A Value & Pricing Framework
■ Pricing Optimally to Navigate New Policy Reality
■ Global pricing interdependencies
AMIT PATEL
Indegene
DAKSHA GUPTA
Indegene
12:30 – Networking luncheon
13:30 – Read, Delete, Forget? Making Risk Communication Worth Opening
- Risk communication is accurate, compliant and carefully reviewed. Is it also read, understood and acted upon?
- Why materials that healthcare professionals and patients value often fail to reach them or to change what they do
- What field colleagues in our own markets told us when we asked them about our materials
- Practical ideas for risk communication that inspires action rather than just documenting distribution
SABINE POLTERMANN
Bristol-Myers Squibb
DAKSHA GUPTA
Indegene
REGULATORY
14:00 – Panel Discussion – UK & EU Pharmacovigilance in Transition: Navigating Regulatory Change, Divergence & Emerging Compliance Expectations
With evolving UK requirements, continuing EU GVP revisions and new international standards such as ICH E2D(R1), how should PV leaders prepare their systems, processes and governance for the next regulatory phase?
Moderator
PAV RISHIRAJ
Celltrion
Panellists
CALVIN JOHNSON
Bristol-Myers Squibb
MICHAEL BEAN
Johnson & Johnson
MEI YANG
NouStarX
COLLABORATING FOR ACCESS
14:20 – Keynote Panel Discussion: Stronger Together: Bridging industry, payers, and patients for better access. Powering access through collaboration
Moderator
CHERYL ROCHE ALEXANDER
UCB (Former)
Panellists
DIVAY MOR
Sun Pharma
JOAQUIN MOULD
CSL Seqirus
BOXIONG TANG
Ascentage Pharma
DIEGO CORTINA DE LA FUENTE
Takeda
DIEGO CORTINA DE LA FUENTE
Takeda
JOAQUIN MOULD
CSL Seqirus
14:50 – Chairperson’s closing remarks
15:00 – 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 10th Annual Pharma Pricing, Reimbursement & Market Access USA 2026 summit. Together, we are fostering the innovation and collaboration needed to safeguard patients worldwide.”
Title Partner
Thought Leader
Associate Partners
Thought Leader
Lanyard Partner
Event Venue
London Heathrow Marriott Hotel
Philadelphia
UK
+1 833-472-5483
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Bookings
super early bird Price
1 Delegate
vaild till
[6 dec]
£ 799 + VAT
All-Access Pass – 1 Person
Strategic Coverage – Single Perspective
Networking Platform – Full Access
Innovation Insights – from global industry leaders
Digital Resource Hub – Included
Professional Certificate – 1 Certificate
Best For – Solo Professionals
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3 Delegates (3 for 2)
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[6 dec]
Bring the whole team and save £ 799 instantly
£ 1598 + VAT
All-Access Pass – 3 People
Strategic Coverage – Divide & Conquer All Sessions
Networking Platform – Full Access for the Entire Team
Innovation Insights – from global industry leaders
Digital Resource Hub – Included
Professional Certificate – 3 Certificates
Best For – Corporate Teams & Decision Makers
early discount Price
1 Delegate
vaild till
[7 dec - 17 jan ]
£ 999 + VAT
All-Access Pass – 1 Person
Strategic Coverage – Single Perspective
Networking Platform – Full Access
Innovation Insights – from global industry leaders
Digital Resource Hub – Included
Professional Certificate – 1 Certificate
Best For – Solo Professionals
Most Popular
early discount Price
3 Delegates (3 for 2)
vaild till
[7 dec - 17 jan ]
Bring the whole team and save £ 999 instantly
£ 1998 + VAT
All-Access Pass – 3 People
Strategic Coverage – Divide & Conquer All Sessions
Networking Platform – Full Access for the Entire Team
Innovation Insights – from global industry leaders
Digital Resource Hub – Included
Professional Certificate – 3 Certificates
Best For – Corporate Teams & Decision Makers
Standard Price
1 Delegate
$ 1,599
All-Access Pass – 1 Person
Strategic Coverage – Single Perspective
Networking Platform – Full Access
Innovation Insights – from global industry leaders
Digital Resource Hub – Included
Professional Certificate – 1 Certificate
Best For – Solo Professionals
Most Popular
Standard Price
3 Delegates (3 for 2)
Bring the whole team and save $ 1,599 instantly
$ 3,198
All-Access Pass – 3 People
Strategic Coverage – Divide & Conquer All Sessions
Networking Platform – Full Access for the Entire Team
Innovation Insights – from global industry leaders
Digital Resource Hub – Included
Professional Certificate – 3 Certificates
Best For – Corporate Teams & Decision Makers
Accommodation
We have secured special room rates for our conference participants who wish to stay at the conference venue hotel “Wyndham Boston Beacon Hill Hotel” during the conference dates.
Once you confirm your participation, our operations team will share the room reservation details along with the booking deadline and the special rates we’ve arranged.
Event Testimonials
United Kingdom
Block 3, 86 Coombe Road
Croydon CR0 5RA
London, UK
Asia
Plot No – 07 – 2nd Floor
Ekambaram Industrial Estate
Alapakkam, Porur Chennai,
India – 600 116
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