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Event Schedule - 2026

Our Events Schedule Plan

Registration & Refreshments

Kick off your conference experience by checking in at our registration desk. Collect your event materials and enjoy a selection of refreshments. It's the perfect time to mingle with fellow attendees and set the tone for an engaging and informative event

Download our app now to connect with attendees, enhance your networking opportunities, and stay updated effortlessly!

Welcome Address & Chairperson’s Opening Remarks

Opening remarks setting the context for Pharmacovigilance World 2026, outlining the key themes, regulatory landscape, and objectives for the conference. Setting expectations for learning, networking, and practical takeaways over two days

Michael Ramcharan

Managing Director

Reumat Consulting

From Pharmacovigilance to Patient Safety: Realizing Impact in Clinical Practice

Jean-Marc C. Haeusler

Global Head International Patient Safety

Roche

Patient Centric Drug Safety
Adverse Drug Reactions
MHRA Case Study: The use of conditional questions to improve spontaneous reporting data: lessons learnt from a regulatory perspective

Sou Mieng Tran

Vigilance Collaborations Specialist

Medicines and Healthcare products Regulatory Agency

Data management & Analytics
Regulatory Compliance
More Channels, More Signals, More AI: How Pharma Teams Engage Confidently

Emma Durant

Strategic Client Partner

Resolver

When things go wrong – A human engineering viewpoint

Andrew Cooper

Senior Director Business Partnering Pharmacovigilance, Regulatory Affairs, Medical

GSK

Business Card Exchange with Morning Coffee/Tea & Discussion

Network over morning coffee or tea, exchanging business cards or using our app's QR code scanner for easy contact sharing. A prime moment for engaging discussions and new connections

Download our app now to connect with attendees, enhance your networking opportunities, and stay updated effortlessly!

Automation and AI's Game-Changing Role in Pharmacovigilance and Drug Safety

Cecilia L Naessan

Cluster Safety Lead North Europe/ Country Safety Lead Norway

Pfizer

Data management & Analytics
AI & Automation
Case Management
Global Patient Safety Leadership across Regions – aligning local affiliates with global PV strategy

Wivina De Waele

Sr. Director Safety Lead Europe, Global Patient Safety

AstraZeneca

Global Pharmacovigilance
Regulatory Compliance
Patient Safety
Challenges and solutions regarding new PV legislation in non-EU countries, with a focus on clinical trial regulations
  • The value of a regional setup.
  • A summary of the differences between EU and non-EU PV regulations.
  • Our agility in implementing new PV legislation and guidelines.
  • Regulatory shifts in expanding clinical trial markets in Eastern Europe and CIS countries.

Ivana Hezoucky

Regional Patient Safety Manager

Boehringer Ingelheim

Global Pharmacovigilance
Regulatory Compliance
Joint MHRA and Health Canada GVP Inspection Experience

Tayibah Mahmood

Senior Drug Safety Officer

Pfizer

Luncheon & Networking - Explore, Engage with Your Peers and Connect at Our Exhibitor Booths

Enjoy a luncheon while networking with peers and exploring exhibitor booths. This is an ideal time to engage with industry leaders, delve into innovative solutions, and forge valuable connections in a collaborative atmosphere.

Download our app now to connect with attendees, enhance your networking opportunities, and stay updated effortlessly!

Panel Discussion: Beyond Compliance: Building a Proactive Drug Safety Culture

How leading organisations are embedding pharmacovigilance into decision-making, culture, and strategy - moving from reactive compliance to proactive patient safety.

  • How can pharmacovigilance move from a compliance function to a strategic driver of patient safety?
  • What does true cross-functional ownership of drug safety look like in practice?
  • Are current KPIs driving the right behaviours or just ticking boxes?
  • How can leadership create accountability for proactive safety decisions?
Global Pharmacovigilance
Quality Assurance
Patient Safety

Michael Ramcharan

Managing Director

Reumat Consulting

Ivana Hezoucky

Regional Patient Safety Manager

Boehringer Ingelheim

Judy Barretto

Senior Director

Gilead Sciences

Sandra Reda

Senior Pharmacovigilance Specialist

Newbridge Pharmaceuticals

Brian Edwards

Managing Director

Husoteria Ltd

AI-Enabled Signal Detection in Pharmacovigilance: From Algorithms to Machine Learning

Cristina Ruscanu

Independent Pharmaceutical Consultant

Data management & Analytics
AI & Automation
Safety Signals & Management
Building Inspection-Ready Pharmacovigilance Systems: From GVP Compliance to Regulatory Authority Confidence

A Regulatory Authority and Sponsor-Side Perspective on Pre-Inspection Preparation, During-Inspection Excellence, and Post-Inspection CAPA Management

  • Understand what regulatory authorities specifically assess during routine PV inspections—moving beyond generic compliance checklists to inspector-led operational scrutiny
  • Apply the Six Pillars framework (PSMF Governance, Data Integrity, Signal Detection Robustness, Case Processing Quality, Vendor Oversight, Safety Committee Governance) to conduct self-assessment and identify gaps
  • Master pre-inspection preparation strategies, including mock inspection scenarios, staff coaching, and evidence compilation
  • Develop post-inspection CAPA management protocols anchored in ICH Q9 risk-based root cause analysis and regulatory citation closure

Amer Alghabban

R&D Quality Regulatory Authority Inspection Management

Bristol Myers Squibb

Rethinking the PSMF: Smarter Content, Smarter Delivery
  • Traditional PSMF Model: How PSMFs are typically structured and maintained today and why this approach is becoming increasingly difficult to sustain.
  • Inside the Complexity: Unpacking the challenges of remaining inspection-ready.
  • A Smarter Modular Content Approach: Move toward structured, modular content with a clear separation of static and dynamic data to improve consistency, control, and efficiency.
  • Making It Happen: Practical steps for transition, including governance, system, and change management considerations.

Katherine Kennedy

Senior PV Quality Director

Roche

Quality Assurance
Regulatory Compliance
PV Audits & Inspections
Recharge with Tea or Coffee While Networking

Refresh with a tea or coffee break, using this time to continue networking. It's a perfect opportunity to discuss ideas, share experiences, and connect with fellow attendees in a relaxed setting.

Download our app now to connect with attendees, enhance your networking opportunities, and stay updated effortlessly!

PV oversight over Third-parties

Sandra Reda

Senior Pharmacovigilance Specialist

Newbridge Pharmaceuticals

Quality Assurance
Pharmacovigilance Outsourcing
PV Audits & Inspections
Beyond Case Processing: Building High-Value Pharmacovigilance Partnerships
  • Why quality case processing and adverse drug reaction reporting remain the foundation of effective pharmacovigilance
  • The impact of quality and operational excellence on patient safety, compliance, and inspection readiness
  • Common challenges in outsourced pharmacovigilance models and how to overcome them
  • What sponsors and partners should expect from successful pharmacovigilance collaborations
  • Building trust, accountability, and long-term value through effective oversight and governance
  • Future trends in pharmacovigilance service delivery, including automation, global talent, and evolving partnership models

Tobi Yusuf

Former Associate Director PV Processes and Partnerships at Astrazeneca

TBX Life Sciences

Case Management
Pharmacovigilance Outsourcing
Development of guiding principles for Human performance for the WHO Pharmacovigilance strategy

Brian Edwards

Managing Director

Husoteria Ltd

Patient Centricity within the TA Perspective

Judy Barretto

Senior Director

Gilead Sciences

Chairperson’s Closing Remark

End of Day 1 with the Chairperson's closing remarks and summarising key insights

Michael Ramcharan

Managing Director

Reumat Consulting

Networking Drinks Session

Wrap up the day with evening drinks and lively conversations. A relaxed setting to network, share insights from the day, and enjoy the company of fellow attendees.

Download our app now to connect with attendees, enhance your networking opportunities, and stay updated effortlessly!

Day 2   
Registration & Refreshments

Start the second day of the conference by checking in and grabbing a morning refreshment. It’s a great opportunity to re-engage with peers, discuss the previous day’s insights, and prepare for another day of learning and networking.

Download our app now to connect with attendees, enhance your networking opportunities, and stay updated effortlessly!

Welcome Address & Chairperson’s Opening Remarks

Opening remarks outlining the focus of Day 2 on technology, data, automation, and future pharmacovigilance operating models.

Michael Ramcharan

Managing Director

Reumat Consulting

Industry Perspective on Pharmacovigilance Inspections Across the Globe

Aarti Bahirat

Quality Auditor, Manager

GSK

Global Pharmacovigilance
PV Audits & Inspections
Practical AI-Enabled Automation in PV Workflows: A Real-World Implementation Supporting a Pregnancy Prevention Programme (PPP)

Tugce Karakas

Head of Patient Safety

Bristol Myers Squibb

AI and Pharmacovigilance: Use of artificial intelligence to leverage RWD in pharmacovigilance for patient safety

Sandrine Colas

Pharmacoepidemiologist - General Medecine

Sanofi

Pharmacoepidemiology and Real-World Evidence (RWE) Generation
  • The role of real-world evidence in the evaluation of drug safety and effectiveness in diverse patient populations
  • The practical applications of real-world evidence in informing regulatory decisions, clinical guidelines, and healthcare policies
  • The challenges in utilizing real-world evidence, such as data quality, bias, and standardization
  • Emerging trends and innovations in pharmacoepidemiology and RWE generation for evidence-based healthcare with a focus on target trial emulation

Puja Myles

Director, Clinical Practice Research Datalink

Medicines and Healthcare products Regulatory Agency

Data management & Analytics
Patient Safety
Post-Marketing Surveillance
Business Card Exchange with Morning Coffee/Tea & Discussion

Network over morning coffee or tea, exchanging business cards or using our app's QR code scanner for easy contact sharing. A prime moment for engaging discussions and new connections.

Download our app now to connect with attendees, enhance your networking opportunities, and stay updated effortlessly!

Patient Centricity in Pharmacovigilance

Lizanne Pistorius

Head of Patient Safety & Pharmacovigilance

Boehringer Ingelheim

Global Pharmacovigilance
Patient Centric Drug Safety
Patient Safety
Panel Discussion - Leading Pharmacovigilance in a Changing Landscape: What Needs to Evolve Next?

A discussion on how leadership in pharmacovigilance is evolving in response to increasing data, regulatory expectations, and technological change.

  • What are the biggest shifts you’re seeing in pharmacovigilance today?
  • How is the role of PV leaders changing within organisations?
  • What capabilities will future PV teams need to succeed?
  • Where should organisations focus to stay ahead in this evolving landscape?
Global Pharmacovigilance
Quality Assurance
Adverse Drug Reactions
Patient Safety

Michael Ramcharan

Managing Director

Reumat Consulting

Puja Myles

Director, Clinical Practice Research Datalink

Medicines and Healthcare products Regulatory Agency

Joanne Rogerson

Director of Operations

Resolver

Sandra Reda

Senior Pharmacovigilance Specialist

Newbridge Pharmaceuticals

Jean-Marc C. Haeusler

Global Head International Patient Safety

Roche

Aliki Taylor

Executive Director, RWE TA Head - Oncology

Gilead Sciences

Rethinking Safety Signals: What You Might Miss Is Already Public Exploring agentic AI for continuous safety intelligence from real-world digital discourse

Janik Jaskolski

CEO & Co Founder

Semalytix

Balancing Local Operational Realities with Global Pharmacovigilance Standards

Maija Gaide

Pharmacovigilance manager Baltics

Viatris

Global Pharmacovigilance
Quality Assurance
Regulatory Compliance
Luncheon & Networking - Explore, Engage with Your Peers and Connect at Our Exhibitor Booths

Enjoy a luncheon while networking with peers and exploring exhibitor booths. This is an ideal time to engage with industry leaders, delve into innovative solutions, and forge valuable connections in a collaborative atmosphere.

Download our app now to connect with attendees, enhance your networking opportunities, and stay updated effortlessly!

PSMF in Practice: From Compliance Document to Strategic Pharmacovigilance Tool

Caroline Fitzsimons

Associate Director, Pharmacovigilance QA

Jazz Pharmaceuticals

Deborah Robinson

Senior Manager, International QPPV Office and Deputy UK QPPV

Jazz Pharmaceuticals

Global Pharmacovigilance
Regulatory Compliance
Living the Patient Safety Scientific Business Partner Role

Suna Fernandes

Associate Director, Patient Safety

Bristol Myers Squibb

AI & Machine Learning's Game-Changing Role in Pharmacovigilance and Drug Safety

Aliki Taylor

Executive Director, RWE TA Head - Oncology

Gilead Sciences

AI & Automation
Drug safety
From Incident to Improvement: Improving Patient Safety Through National Clinical Review & System Learning

Sharon Howarth

Patient Safety Lead, Clinical Review

NHS England

Vendor oversight by design : a strategic framework for outsourced PV
  • From outsourcing execution to ownership and control
  • Aligning vendor oversight with regulatory expectations and business strategy
  • Building an inspection proof oversight model across global PV vendors

Anne-Claire Gerbier

Global Patient Safety Vendor Oversight Manager

Ipsen

Quality Assurance
Pharmacovigilance Outsourcing
PV Audits & Inspections
Recharge with Tea or Coffee While Networking

Refresh with a tea or coffee break, using this time to continue networking. It's a perfect opportunity to discuss ideas, share experiences, and connect with fellow attendees in a relaxed setting.

Download our app now to connect with attendees, enhance your networking opportunities, and stay updated effortlessly!

What is RWE and how can it be used?

Abda Mahmood

Associate Director, Global Real World Evidence and Health Outcomes

GSK

Safety reporting requirements and safety assessments for IND studies (Dec 2025 FDA Guidance)
  • Safety Evaluation Plan
  • Safety assessments
  • Expedited reporting triggered by findings from aggregate data

Rudi Scheerlinck

Owner

Patient Safety Rudi Scheerlinck S.a.r.l.

Risk Management
Patient Safety
Post-Marketing Surveillance
Towards responsible agentic AI for pharmacovigilance

Arijit Patra

Senior Principal Scientist

UCB

Chairperson’s closing remarks & End of Conference

End the conference with the Chairperson's closing remarks, summarizing key insights and leaving attendees with final thoughts to inspire ongoing engagement and action.

Michael Ramcharan

Managing Director

Reumat Consulting

   Day 1

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