Amsterdam, 7 - 8 October 2025

Schedule

Create your personal agenda –check the favourite icon

Oct 78:00
Conference pass

Registration & Networking Meetings

Keynotes

Networking meetings in the exhibition hall.

Oct 78:55
Conference pass

Chair's Remarks

Keynotes
Mariette Boerstoel, Senior Vice President, Worldwide Patient Safety Officer, Bristol Myers Squibb
Oct 79:00
Conference pass

Session Reserved for GSK

Keynotes
Jens-Ulrich Stegmann, Senior Vice President, Head Clinical Safety and Pharmacovigilance, EU QPPV, GSK
Oct 79:20
Conference pass

Operationalizing AI: turning innovation into everyday excellence

Keynotes

Reserved for ArisGlobal

Moderator: Aman Wasan, CEO, ArisGlobal
Mariette Boerstoel, Senior Vice President, Worldwide Patient Safety Officer, Bristol Myers Squibb
Felix Arellano, Senior Vice President, Global Head of Safety and Risk Management, Roche
Oct 79:40
Conference pass

Session Reserved for Sandoz

Keynotes
Shaloo Pandhi, Global Head, Patient Safety, Sandoz
Oct 710:00
Conference pass

Unified safety: key to efficiency and deeper patient insights

Keynotes
Adrian Maynier, Head of Safety Systems, UCB
David Kolosic, Director, Safety Strategy, Veeva Systems
Oct 710:20
Conference pass
Oct 710:40
Conference pass

Patient-centric pharmacovigilance: elevating the patient voice in pharmacovigilance

Keynotes
Sanjay Vyas, President,Global Head Safety & Logistics,Managing Director India, Parexel
Stacy Hurt, Chief Patient Officer, Parexel International LLC
Oct 711:00
Conference pass

Morning Break & Interactive Poster Sessions

Keynotes

Networking break & interactive poster sessions in the exhibition hall.

Oct 711:55
Conference pass
Oct 711:55
Conference pass
Oct 711:55
Conference pass

Chair's Remarks

Risk Management, Exhibition Theatre 1
Oct 711:55
Conference pass

Chair's Remarks

Signal Detection & Management, Exhibition Theatre 2
Fabian Heisig, Chief Medical Officer, Senior Vice President, Head Global Drug Safety & QPPV, Grunenthal
Oct 711:55
Conference pass

Chair's Remarks

Quality Assurance, G103
Dany Ward, Executive Director, Head of PV Ops & Global Risk Management, Jazz Pharmaceuticals
Oct 711:55
Conference pass

Chair's Remarks

Compliance, G104
Gloria Bustos, Global Head Global Patient Safety, Vantive
Oct 711:55
Conference pass

Chair's Remarks

Medical Devices, G105

Chair's Remarks

Oct 711:55
Conference pass

Chair's Remarks

Patient Centricity, G106
Yvonne Nanciu, Country Head, Pharmacovigilance, Deputy EU QPPV, BAYER
Oct 711:55
Conference pass
Oct 711:55
Conference pass

Chair's Remarks

Outsourcing, G109
Rita Lobatto, Executive Director, Patient Safety & Pharmacovigilance, RP&L Consultancy
Oct 712:00
Conference pass

Advancing automation in aggregate reports

Automation, G102
Israel Gutierrez, Chief Medical Officer, TLR Therapeutics Inc
Oct 712:00
Conference pass

Advancing local patient safety perspectives in PV regulations

Patient Centricity, G106
Antonella Fretta, Senior Director, Aggregate Reporting Team Lead, Pfizer
Oct 712:00
Conference pass

AI & real-world data in signal management: rare diseases and beyond

Artificial Intelligence, Auditorium
Michael von Forstner, Clinical Development Leader, Crearene AG
Oct 712:00
Conference pass

Implementation and reporting requirements for medical devices in the EU AI Act

Medical Devices, G105
Sebastian Fischer, Regulatory Strategy Principal, TUV SUD Product Service GmbH
Oct 712:00
Conference pass

Organising regulatory intelligence: tracking new regulations across the PV industry

Quality Assurance, G103
Barbara Bovy, Director, Head of Quality Intelligence, UCB
Oct 712:00
Conference pass

Pharmacovigilance Systems and Process Standards (PS²) – a cross-industry initiative to foster innovation through standardization

Digital Transformation, G107
Thomas Kuckuk, Head, Pharmacovigilance Systems Management, Novartis
Oct 712:00
Conference pass

Safety strategy and benefit risk

Risk Management, Exhibition Theatre 1
Chris Bone, Director, Safety and Benefit Risk, Biogen
Oct 712:00
Conference pass

Signal management for gene therapies

Signal Detection & Management, Exhibition Theatre 2
Céline Muffang, Director, Medical Safety and Benefit Risk Assessment, AskBio
Oct 712:00
Conference pass

Transforming local safety roles: a case study for innovation and regulatory changes

Compliance, G104
Willemijn Van Der Spuij, Executive Director, International Patient Safety, Bristol Myers Squibb
Oct 712:00
Conference pass

What does a mid-sized pharma really need from its PV vendor?

Outsourcing, G109
Howard Snow, Vice President, Global Head of Pharmacovigilance, Sobi (Swedish Orphan Biovitrum)
Oct 712:20
Conference pass

Assuring compliance in an era of platform transformation

Automation, G102

Session Reserved for Pinnaxis

Vedaant Shourie, Director, Professional Services, Pinnaxis
Oct 712:20
Conference pass

Building trust in AI for drug safety: lessons from developing a generative AI intake tool

Digital Transformation, G107
Asad Rashid, VP, Safety & Pharmacovigilance, Syneos Health
Jonathon Romero, Principal Safety & Pharmacovigilance Ops Specialist, Syneos Health
Oct 712:20
Conference pass

Navigating compliance: AI, MDR & IVDR

Medical Devices, G105
Raghu Murthy, Senior Director, Sophos IT Services
Oct 712:20
Conference pass

Risk Management for combination products: unraveling the balancing act between drugs & devices

Risk Management, Exhibition Theatre 1

Session Reserved for COD Research

Dr. Jay Dave, Technical Director, Global Patient Safety & Risk Management, COD Research Pvt LTD
Oct 712:20
Conference pass

Session Reserved for Indegene

Artificial Intelligence, Auditorium

Session Reserved for Indegene

Oct 712:20
Conference pass

Session Reserved for ProductLife Group

Compliance, G104

Session Reserved for ProductLife Group

Oct 712:20
Conference pass

Session Reserved for Qinecsa

Signal Detection & Management, Exhibition Theatre 2

Session Reserved for Qinecsa

Oct 712:20
Conference pass

Session Reserved for RiverArk

Quality Assurance, G103

Session Reserved for RiverArk

Oct 712:20
Conference pass

Simplifying PV – in a way never done before

Patient Centricity, G106
Vivek Ahuja, Executive Vice President, Pharmacovigilance, Eversana
Oct 712:20
Conference pass

Vision 2030: charting the future of pharmacovigilance outsourcing

Outsourcing, G109

Driving towards higher-quality outputs faster, irrespective of volume and complexity.

  • How the landscape has changed
  • What should patient safety look like in 2030 and what is the role of outsourced partner in this model
  • The shift in mindset and associated challenges
Alan White, CEO, Arriello
Oct 712:40
Conference pass

Automated semi-quantitative signal detection

Signal Detection & Management, Exhibition Theatre 2
Oct 712:40
Conference pass

Creating collaborative data spaces for patient safety

Digital Transformation, G107
Jost Leemhuis, Patient Safety, Roche
Oct 712:40
Conference pass

Early strategies for risk management in clinical trials

Risk Management, Exhibition Theatre 1
Oct 712:40
Conference pass

Governance for the future of AI in the PV industry

Artificial Intelligence, Auditorium
Oct 712:40
Conference pass

How outsourcing plays a critical role in optimizing the affiliate pharmacovigilance structure

Outsourcing, G109
Oct 712:40
Conference pass

Implementation of safety variations to fulfil cross-functional compliance requirements

Compliance, G104
Balaji Malla, Head of Pharmacovigilance, EU & UK QPPV, Dr Reddys Laboratories Limited
Oct 712:40
Conference pass

Leveraging clinical safety to predict and prevent risk to patients

Patient Centricity, G106
Shanti Werther, Executive Director, Global Safety Head, Immunology Patient Safety, Biopharma, AstraZeneca
Oct 712:40
Conference pass

Partnering for successful inspections

Quality Assurance, G103
Natalia Quintana, Associate Director, GPV Performance Excellence, kyowa kirin
Oct 712:40
Conference pass

Speaker presentation

Automation, G102

Speaker presentation

Oct 712:40
Conference pass

The role of medical doctors in risk management for medical devices

Medical Devices, G105

Medical doctors play a critical, yet often underappreciated, role in the risk management lifecycle of medical devices. Their clinical insight is essential for identifying potential hazards, assessing real-world risks, and shaping safer, more effective products. This presentation explores how physicians contribute across key phases of medical device development and post-market surveillance, including clinical risk identification, usability assessment, adverse event analysis, and patient safety advocacy.

As both end-users and patient advocates, medical doctors offer a unique perspective that bridges clinical practice and engineering. Their engagement in risk management processes not only improves device safety but also fosters innovation that aligns with clinical realities. Attendees will leave with a clear understanding of how to integrate medical expertise into cross-functional risk management teams to elevate both patient safety and product success.

Oct 713:00
Conference pass

AI unleashed: driving workflow insights and case intake efficiencies in pharmacovigilance

Artificial Intelligence, Auditorium

Session Reserved for ArisGlobal

Jason Bryant, Senior Vice President, Product Management - AI, ArisGlobal
Oct 713:00
Conference pass

Building a robust local literature screening framework: lessons from the field

Compliance, G104
Ada Stelmakiene, Head of Pharmacovigilance, Insuvia
Oct 713:00
Conference pass

How to stay inspection-ready and compliant under EU Regulation 2025/1466

Quality Assurance, G103

Sponsor Presentation

Peter Psarologos, Senior QPPV, UBC
Oct 713:00
Conference pass

Refocusing on patients: leveraging AI to reclaim our pur-pose

Patient Centricity, G106

Session Reserved for DeltaPV

Aytek Dağistanli, CEO, DeltaPV
Oct 713:00
Conference pass

Session Reserved for ALWIS

Digital Transformation, G107

Session Reserved for ALWIS

Oct 713:00
Conference pass

Session Reserved for Orbit by Feith Systems

Risk Management, Exhibition Theatre 1

Session Reserved for Orbit by Feith Systems

Oct 713:00
Conference pass

Session Reserved for Parexel

Signal Detection & Management, Exhibition Theatre 2

Session Reserved for Parexel

Oct 713:00
Conference pass

Session Reserved for Soterius

Outsourcing, G109

Session Reserved for Soterius

Oct 713:00
Conference pass

Sponsor presentation

Medical Devices, G105

Sponsor presentation

Oct 713:00
Conference pass

The role of Agentic AI in PV automation

Automation, G102
Michael Braun-Boghos, Senior Director, Safety Strategy, Oracle Health and Life Sciences
Oct 713:20
Conference pass

Lunch

Keynotes

Lunch options purchasable in the exhibition hall.

Oct 714:45
Conference pass

01 Artificial Intelligence Panel – Reserved for Primevigilance

Artificial Intelligence, Auditorium

Reserved for Primevigilance

Oct 714:45
Conference pass

02 Automation Panel - The road to AI success: how to operationalize for sustainable value

Automation, G102

The session will cover:

  • Building the right foundation – data quality, governance, and infrastructure considerations
  • Scaling to production – overcoming challenges in deployment and adoption
  • Change management & culture – preparing teams for new ways of working
  • Measuring Success – establishing KPIS to track value creation and sustainability
  • Use Cases – how you’ve operationalized AI delivering sustainable value
Claudia Lehmann, Vice President, Head, Patient Safety & Pharmacovigilance Operations, Boehringer Ingelheim International
Bina Patel, Associate Vice President, Pharmacovigilance Operations, Amgen
Attila Oláh, Vice President, Head, Global Patient Safety, EU-QPPV, Gedeon Richter Plc
Moderator: Ann-Marie Orange, Chief Information Officer and Global Head of R&D, ArisGlobal
John Ennion, Data, Digital & IT Business Partner for Global Regulatory Affairs, R&D Quality and Global Patient Safety, EMD Serono
Oct 714:45
Conference pass

03 Risk Management Panel - Implementing benefit-risk frameworks: engaging patients and new tools

Risk Management, Exhibition Theatre 1
Lisa Benaise, Head of Global Pharmacovigilance, Miltenyi Biotec
Gyorgy Zorenyi, Senior Medical Director, Medical Safety, Jazz Pharmaceuticals
Nicola Charpentier, Vice President, Head of Benefit Risk Management, Medical Safety and Pharmacovigilance, BioNTech
Moderator: Sven Kohler, Vice President, EU-QPPV and Head Regional Patient Safety and PV, Boehringer Ingelheim
Oct 714:45
Conference pass

04 Signal Detection & Management Panel – Optimising signal detection for product competitiveness during clinical development and on the market

Signal Detection & Management, Exhibition Theatre 2
Moderator: Magnus Nord, Vice President, Global Patient Safety BioPharma, AstraZeneca
Jan Cleerbout, Deputy QPPV, Johnson & Johnson Innovative Medicine
Peter De Veene, Associate Vice President, Global QPPV, MSD
Dimitrios Zampatis, Director, Product Patient Safety, Sandoz
Oct 714:45
Conference pass

05 Quality Assurance Panel – Behind the curtains of inspections: recent advances in GVP inspections

Quality Assurance, G103
Devang Patel, Head of Global Pharmacovigilance, Zydus Lifesciences Limited
Fabio Miceli, EU QPPV, Norgine
Marianne Mounir, Senior Global Auditor, BAYER
Ranjana Khanna, Global Director, GVP, QA, R&D Quality, BeiGene
Oct 714:45
Conference pass

06 Compliance Panel - Ensuring PSMF compliance and inspection readiness

Compliance, G104
Jean Kilgour-Christie, Deputy EU QPPV Head, UK QPPV, Sandoz
Pat Harding, Senior Director, International PV Operations (PSMF), Eli Lilly and Company
Zoe Hamill, GPvP Inspector, MHRA
Zoltán Barna, Head, Global PV Compliance, Gedeon Richter Plc
Oct 714:45
Conference pass

07 Medical Devices Panel – Current perspectives on different safety approaches between pharmaceutical, medical devices and combination products

Medical Devices, G105
Oct 714:45
Conference pass

08 Patient Centricity Panel – Advancing patient centered risk minimization measures

Patient Centricity, G106
Marcin Marciniak, Senior Director, Global Safety and PV Expert WHC, Gedeon Richter U.K. Ltd
Dieter Wetzel, Head of Medical Science, toclinco GmbH
Mary Lynne van Poelgeest-Pomfret, President, World Federation for Incontinence and Pelvic Problems (WFIPP)
Moderator: Mark Daniels, Senior Medical Director, Medical Safety, Jazz Pharmaceuticals
Hira Rizvi, Medical Safety Officer, Sanofi
Oct 714:45
Conference pass

09 Digital Transformation Panel – How digital transformation is transforming pharmacovigilance

Digital Transformation, G107
Jonas Maselis, Head of Digital Technology Patient Safety, UCB
Thomas Kuckuk, Head, Pharmacovigilance Systems Management, Novartis
Jan Holzer, PV Innovation & Solutions Lead, CSL Behring
Moderator: Malin Kreitz, Director, European Operations, Ultragenic Research & Technologies LLC
Oct 714:45
Conference pass

10 Outsourcing Panel – Vendor oversight: challenges and opportunities for PV outsourcing

Outsourcing, G109
Steve Dingman, Vice President, Pharmacovigilance, Head of Safety, Merus NV
Mette Stie Kallesøe, Head of Pharmacovigilance, QPPV, Hansa Biopharma
Maximilian Jacobs, Head of Vendor Management, Pharmacovigilance, Bayer AG
Irina Ghiorghiu, Global Lead Vendor Management, Opella Healthcare Group
Eniko Barta Kondas, Head, Global PV Operations, Gedeon Richter Plc
Oct 715:45
Conference pass

Chair's Remarks

Artificial Intelligence, Auditorium
Nibedita Rath, Scientific Director, Open Source Pharma Foundation
Oct 715:45
Conference pass

Chair's Remarks

Automation, G102
Attila Oláh, Vice President, Head, Global Patient Safety, EU-QPPV, Gedeon Richter Plc
Oct 715:45
Conference pass

Chair's Remarks

Signal Detection & Management, Exhibition Theatre 2

Chair's Remarks

Ana Sofia Afonso, Director, Pharmacoepidemiology, Global Patient Safety, Eli Lilly
Oct 715:45
Conference pass

Chair's Remarks

Quality Assurance, G103
Tanja Hoffman, Owner, Executive Consultant, Independent PV Expert
Oct 715:45
Conference pass

Chair's Remarks

Compliance, G104

Chair's Remarks

Oct 715:45
Conference pass

Chair's Remarks

Medical Devices, G105

Chair's Remarks

Sujith Madhavan, Medical Director, Pharmacovigilance, Jazz Pharmaceuticals
Oct 715:45
Conference pass

Chair's Remarks

Patient Centricity, G106
Eveline Schurink, Vice President, Clinical Development, Patient Safety & Medical Affairs, Alvotech
Oct 715:45
Conference pass

Chair's Remarks

Digital Transformation, G107
Ariane Stollenwerk, Director, Head of Safety Central Europe & APAC, UCB
Oct 715:45
Conference pass

Chair's Remarks

Outsourcing, G109
Mina G Awad, Pharmacovigilance Senior Manager and QPPV, Middle East, Kyowa Kirin International
Oct 715:45
Conference pass

Chair's Remarks - AXIAN

Risk Management, Exhibition Theatre 1

Chair's Remarks

Mark Perrott, Managing Partner, Axian Consulting ltd.
Oct 715:50
Conference pass

A lifecycle approach to risk management planning, design, integration and measurement

Risk Management, Exhibition Theatre 1
Mark Perrott, Managing Partner, Axian Consulting ltd.
Oct 715:50
Conference pass

Advancing AI in medical devices & QMS usage of AI

Medical Devices, G105

Speaker presentation

Ryan Magee, Founder & Vice President of Engineering, IMPAQT Engineering
Oct 715:50
Conference pass

Advancing signal detection with social media listening

Signal Detection & Management, Exhibition Theatre 2
Marco Tuccori, Associate Professor of Pharmacology, Department of Diagnostic & Public Health, University of Verona
Oct 715:50
Conference pass

Breaking silos: cross-functional synergy for pro-active safety issue communication

Compliance, G104
Aya Zaghloul, Associate Director, GPS International Pharmacovigilance Operations, Eli Lilly and Company
Oct 715:50
Conference pass

How to embed successful collaboration between PV vendor management and procurement teams

Outsourcing, G109
Mark Cawley, Associate Director, R&D Procurement, Jazz Pharmaceuticals
Oct 715:50
Conference pass

Incorporating AI generated cases into databases: supported by human quality control

Artificial Intelligence, Auditorium
Oct 715:50
Conference pass

Optimal prompt strategies and selection of biomedical LLMs for causality assessment

Automation, G102
Maurizio Sessa, Associate Professor, Pharmacovigilance and Pharmacoepidemiology, University of Copenhagen
Oct 715:50
Conference pass

Patient centricity: a QPPV office perspective

Patient Centricity, G106

Speaker presentation

Oct 715:50
Conference pass

PMDA inspections: CRO oversight

Quality Assurance, G103
Zina Sadeq, Director, Regional PV and Alliance Management, UK QPPV, Amicus Therapeutics
Oct 715:50
Conference pass

Practical digital transformation in pharmacovigilance: building readiness from the ground up

Digital Transformation, G107
Anders Thyme, Director, Pharmacovigilance, Ascendo
Oct 716:10
Conference pass

ARMM Measurement: challenges, opportunities, and the road ahead

Risk Management, Exhibition Theatre 1
Oct 716:10
Conference pass

Evolving regulatory landscape for advanced therapies: navigating clinical safety and pharmacovigilance

Patient Centricity, G106

Sponsor presentation

Vineet Kacker, Managing Director and Global Technical Head, APCER Life Sciences
Oct 716:10
Conference pass

Lifting the lid on PV inspection findings – what can automation do to improve the current situation?

Automation, G102
Oct 716:10
Conference pass

Proactive pharmacovigilance: transforming inspection readiness into business value

Outsourcing, G109

How do you transform compliance from reactive to proactive? Parexel and Norginereveal their game-changing partnership approach to GVP assessment. This presentation showcases their innovative framework that embeds regulatory readiness throughout the entire pharmacovigilance lifecycle—from signal detection to final submissions. Discover how strategic collaboration creates inspection-ready systems that don't just meet standards but anticipate them. Learn practical insights for building resilient pharmacovigilance operations where excellence becomes operational DNA.

Aurelia Bordes, Corporate Vice President, Safety Operations, Parexel International LLC
Chrissa Cooper, Director, Pharmacovigilance, Norgine Ltd
Oct 716:10
Conference pass

Session Reserved for Nextrove

Digital Transformation, G107

Session Reserved for Nextrove

Oct 716:10
Conference pass

Session Reserved for Nextrove

Digital Transformation, G107

Session Reserved for Nextrove

Oct 716:10
Conference pass

Session Reserved for Ultragenic

Artificial Intelligence, Auditorium

Session Reserved for Ultragenic

Oct 716:10
Conference pass

Sponsor presentation

Signal Detection & Management, Exhibition Theatre 2

Sponsor presentation

Oct 716:10
Conference pass

Sponsor presentation

Quality Assurance, G103

Sponsor presentation

Oct 716:10
Conference pass

Sponsor presentation

Compliance, G104

Sponsor presentation

Oct 716:10
Conference pass

Sponsor presentation

Medical Devices, G105

Sponsor presentation

Oct 716:30
Conference pass

AI in action: an AI-powered approach to literature screening

Artificial Intelligence, Auditorium
Robert Westphal, Digital Lead IT Pharma, Chief Medical Office, BAYER
Oct 716:30
Conference pass
Oct 716:30
Conference pass

Inspector’s expectations vs. PSMF reality

Compliance, G104
Sarah Tarnowsky, PSMF Coordinator & Specialist Quality Management, Viatris
Oct 716:30
Conference pass

Processing BOTs in Pfizer - production experience

Automation, G102
Magda Godula, Director, Regional Safety Platform Lead, pfizer
Oct 716:30
Conference pass

Regulatory perspective of risk management planning

Risk Management, Exhibition Theatre 1
Shahin Kauser, Leading Senior Scientific Assessor, MHRA
Oct 716:30
Conference pass

Roche safety database transformation for ICSR management

Digital Transformation, G107
Radoslaw Rysiewski, Product Manager, Compliance and Oversight, Roche
Lucinda Smith, Chief Safety Product Officer • Product Management, ArisGlobal
Oct 716:30
Conference pass

Signal detection: pattern recognition and value of single cases

Signal Detection & Management, Exhibition Theatre 2
Marija Stupar, Senior Director, Head Safety & Benefit Risk, Opioids and Generics, Grünenthal GmbH
Oct 716:30
Conference pass

Speaker presentation

Medical Devices, G105

Speaker presentation

Oct 716:30
Conference pass

Supplier performance management: building sustainable and strategic partnerships at Bayer

Outsourcing, G109
Paul Hoericke, Global Procurement Category Lead Product Lifecycle Management, Bayer AG
Oct 716:30
Conference pass

Translating GVP Module XVI into patient outcomes: effectiveness of risk minimization measures

Patient Centricity, G106
Oct 716:50
Conference pass

Networking Break

Keynotes

Networking break in the exhibition hall.

Oct 717:20
Conference pass

Chair's Remarks

Artificial Intelligence, Auditorium
Yvonne Schäfer, Head of Patient Safety and Pharmacovigilance Systems Business Solutions, Boehringer Ingelheim International
Oct 717:20
Conference pass

Chair's Remarks

Automation, G102

Chair's Remarks

Vivienne van de Walle, Medical Director, P.T. and R
Oct 717:20
Conference pass

Chair's Remarks

Risk Management, Exhibition Theatre 1
Nisha Vora, Safety Science Director, Global Patient Safety, ipsen
Oct 717:20
Conference pass

Chair's Remarks

Signal Detection & Management, Exhibition Theatre 2
Natacha Carragher, Senior Advisor, Pharmacoepidemiology, Global Patient Safety, Eli Lilly
Oct 717:20
Conference pass

Chair's Remarks

Quality Assurance, G103
Elena Keller, Director, PV, RA, Quality and Medical Operations, Local QPPV, Ipsen Pharma GmbH
Oct 717:20
Conference pass

Chair's Remarks

Compliance, G104

Chair's Remarks

Maria Jose Reneses, Senior Director, Deputy EU QPPV & Head of PSMF Team, Takeda
Oct 717:20
Conference pass

Chair's Remarks

Medical Devices, G105

Chair's Remarks

Oct 717:20
Conference pass

Chair's Remarks

Patient Centricity, G106

Chair's Remarks

Jamal Baig, Director, Pharmacovigilance, Country Safety Head, Sanofi
Oct 717:20
Conference pass

Chair's Remarks

Digital Transformation, G107

Chair's Remarks

Oct 717:20
Conference pass

Chair's Remarks

Outsourcing, G109

Chair's Remarks

Oct 717:25
Conference pass

AI chatbots for treatment support and clinical decision making

Artificial Intelligence, Auditorium
Oct 717:25
Conference pass

Global risk management implementation challenges and solutions

Risk Management, Exhibition Theatre 1

With global regulators more closely aligned over RM strategy and assessment activities, sponsors must adaptto avoid approval delays and inspection findings. Learn how Synes Health is helping sponsors across the RM program lifecycleto meet the new regulatory expectations with confidence.

Adel Abou Ali, VP, Global Risk Management and REMS Strategy, Syneos Health
Dawn Hill, VP, Global Risk Management and REMS, Syneos Health
Oct 717:25
Conference pass

How automation increases efficiency and accuracy of local PV monitoring and KPI tracking

Automation, G102

Sponsor presentation

Oct 717:25
Conference pass

PSMF Studio: A tailored content search copilot agent

Compliance, G104
Zeynep Gulder, Senior Manager, QPPV Office, Novartis
Keerthi Chukkapalli, Vigilance Process Manager, Novartis
Oct 717:25
Conference pass

Sponsor presentation

Signal Detection & Management, Exhibition Theatre 2

Sponsor presentation

Oct 717:25
Conference pass

Sponsor presentation

Quality Assurance, G103

Sponsor presentation

Oct 717:25
Conference pass

Sponsor presentation

Medical Devices, G105

Sponsor presentation

Oct 717:25
Conference pass

Sponsor presentation

Patient Centricity, G106

Sponsor presentation

Oct 717:25
Conference pass

Sponsor presentation

Digital Transformation, G107

Sponsor presentation

Oct 717:25
Conference pass

Sponsor presentation

Outsourcing, G109

Sponsor presentation

Oct 717:45
Conference pass

As exploitant, how are we best prepared for a French PV inspection?

Quality Assurance, G103
Agnès Barrere, Local QPPV (RPV), France, Otsuka Pharmaceutical
Oct 717:45
Conference pass

Challenges and pitfalls of automation in smaller companies

Automation, G102
Johanna Strandell, Director, Patient Safety, Camurus AB
Oct 717:45
Conference pass

Managing PV system transformation from a business perspective

Digital Transformation, G107
Pawel Chomiak, Associate Director, Clinical Data Management, MSD
Monika Sarnecka, Associate Director, Clinical Data Management, MSD
Oct 717:45
Conference pass

Pharmacovigilance for OTC products: similarities and differences

Compliance, G104
Rafael Josupeit, EEA QPPV, Procter & Gamble
Oct 717:45
Conference pass

Practical application of artificial intelligence from a safety physician perspective

Artificial Intelligence, Auditorium
Oct 717:45
Conference pass

Risk minimization communication in non-EU countries

Risk Management, Exhibition Theatre 1
Marjan Dzeparoski, RA and PV Manager, Bionika Pharmaceuticals
Oct 717:45
Conference pass

Safety committees for advanced therapies in rare diseases

Signal Detection & Management, Exhibition Theatre 2
Oct 717:45
Conference pass

Speaker presentation

Medical Devices, G105

Speaker presentation

Oct 717:45
Conference pass

Speaker presentation

Outsourcing, G109

Speaker presentation

Oct 717:45
Conference pass

Speaking the same language: enhancing PV–commercial partnerships for robust patient safety oversight

Patient Centricity, G106

Speaker presentation

Oct 718:05
Conference pass

Close of conference and drinks reception

Keynotes

Drink reception in the exhibition hall.

Create your personal agenda –check the favourite icon

Oct 88:55
Conference pass

Chair's Remarks

Keynotes

Chair's Remarks

Corinne Jouquelet-Royer, Senior Vice President, Chief Safety Officer, Head of Patient Safety & Pharmacovigilance, Sanofi
Oct 89:00
Conference pass

Session Reserved for Pfizer

Keynotes
Patrick Caubel, Chief Safety Officer, pfizer
Oct 89:20
Conference pass

Deep research and agentic AI for safety evaluation

Keynotes

Emerging technologies—such as deep research AI and agentic AI systems—can securely access proprietary company data alongside diverse external resources, enabling comprehensive and timely adverse event assessment. This keynote will explore how these advanced AI tools enhance the depth and efficiency of medical review, support earlier signal detection and empower pharmacovigilance physicians to drive data-informed safety decisions across the product lifecycle.

Bruce Palsulich, Strategic Client Executive, Oracle Health and Life Sciences
Oct 89:40
Conference pass

Session Reserved for BeOne Medicines

Keynotes
Han Ma, Senior Vice President, Chief Safety Officer, BeOne Medicines
Oct 810:00
Conference pass

Diamond sponsor

Keynotes

Diamond sponsor

Oct 810:20
Conference pass

Keynote panel discussion - Hype versus hope for artificial intelligence

Keynotes
Moderator: Felix Arellano, Senior Vice President, Global Head of Safety and Risk Management, Roche
Patrick Caubel, Chief Safety Officer, pfizer
Mariette Boerstoel, Senior Vice President, Worldwide Patient Safety Officer, Bristol Myers Squibb
Vicki Edwards, Vice President, Pharmacovigilance Excellence & International QPPV, AbbVie
Oct 811:00
Conference pass

Morning Break & Interactive Poster Sessions

Keynotes

Morning Break & Interactive Poster Sessions

Oct 811:55
Conference pass

Chair's Remarks

Artificial Intelligence, Auditorium
Claudia Lehmann, Vice President, Head, Patient Safety & Pharmacovigilance Operations, Boehringer Ingelheim International
Oct 811:55
Conference pass

Chair's Remarks

Automation, G102

Chair's remarks

Uwe Gudat, Chief Medical Officer, Biocon Biologics
Oct 811:55
Conference pass

Chair's Remarks

Risk Management, Exhibition Theatre 1
Oct 811:55
Conference pass

Chair's Remarks

Signal Detection & Management, Exhibition Theatre 2
Krupa Patel, Senior Safety Scientist, Global Patient Safety, ipsen
Oct 811:55
Conference pass

Chair's Remarks

Quality Assurance, G103
Tina Wirstrom, Director, EU QPPV Office, Takeda
Oct 811:55
Conference pass
Oct 811:55
Conference pass

Chair's Remarks

Risk Management 2, G105
David Chonzi, Independent Pharma Physician, Independent PV Expert
Oct 811:55
Conference pass

Chair's Remarks

Patient Centricity, G106
Deepa Venkataraman, Vice President, Patient Safety and Pharmacovigilance, Corcept Therapeutics
Oct 811:55
Conference pass

Chair's Remarks

Digital Transformation, G107

Chair's Remarks

Oct 811:55
Conference pass

Chair's Remarks

Outsourcing, G109
Marianne Banoub, Regional Head of PV and QA, NewBridge Pharmaceutical
Oct 812:00
Conference pass

Advancing PV intelligence: developing a custom tool for maintaining and accessing regulatory environments

Compliance, G104
Nadine O'Hare, Senior Director, Global Patient Safety, PV Intelligence, Regeneron
Oct 812:00
Conference pass

Aggregate safety assessment planning for optimizing signal detection & management in drug development

Signal Detection & Management, Exhibition Theatre 2
Oct 812:00
Conference pass

Applying the key principles of pharmacovigilance for consumer healthcare products

Patient Centricity, G106
Paraskevi Floroskoufi, CHC Regional PV Head, Europe and Eurasia, Opella Healthcare Group
Oct 812:00
Conference pass

Benefit risk evaluations: views from CIOMS XII

Risk Management, Exhibition Theatre 1
Stéphanie Tcherny-Lessenot, Global Head, Benefit-Risk Evaluation, Sanofi
Oct 812:00
Conference pass

Creation of quality checks for automated safety reporting related activities

Automation, G102
Tuula Ikonen, Head of Pharmacovigilance Department, EORTC
Oct 812:00
Conference pass

Digital innovations at Pfizer to build efficient safety organisations

Digital Transformation, G107
Marcin Kruk, Senior Director, Drug Safety Unit Regional Head, Europe, Africa & Middle East, Pfizer
Oct 812:00
Conference pass

Integrating GenAI in workflows for regulatory agencies

Artificial Intelligence, Auditorium
Elena Prokofyeva, Head of Drug Safety Unit, DG Post, FAMHP - Federal Agency for Medicines and Health Products in Belgium
Oct 812:00
Conference pass

Long term follow up and inspection readiness for gene therapies

Quality Assurance, G103
Kapil Bhutada, Senior Director, Safety Operations and Compliance, Medical Safety & Pharmacovigilance, AskBio
Oct 812:00
Conference pass

Outsourcing to meet the needs of local, regional and global requirements

Outsourcing, G109
Simon Ashworth, Global Head of Safety, Menarini
Oct 812:00
Conference pass

Registry studies and real-world evidence for rare diseases

Risk Management 2, G105
Carolina Buitrago, Medical Director, Global Patient Safety, AstraZeneca & Alexion
Oct 812:20
Conference pass

Create digital transformation through business transformation

Automation, G102
Updesh Dosanjh, Practice Leader, Pharmacovigilance Technology Solutions, IQVIA Inc.
Oct 812:20
Conference pass

Generative to agentic AI: multiplying PV writing impact

Artificial Intelligence, Auditorium
Ikram Baig, CEO, Quartica
Oct 812:20
Conference pass

Key approaches to strengthening patient safety through effective risk management plan controls

Risk Management, Exhibition Theatre 1
Sanjeev Miglani, Founder and Director, AWINSA Life Sciences
Oct 812:20
Conference pass

Session Reserved for Baupharma

Outsourcing, G109

Session Reserved for Baupharma

Oct 812:20
Conference pass

Sponsor presentation

Signal Detection & Management, Exhibition Theatre 2

Sponsor presentation

Oct 812:20
Conference pass

Sponsor presentation

Quality Assurance, G103

Sponsor presentation

Oct 812:20
Conference pass

Sponsor presentation

Compliance, G104

Sponsor presentation

Oct 812:20
Conference pass

Sponsor presentation

Risk Management 2, G105

Sponsor presentation

Oct 812:20
Conference pass

Sponsor presentation

Patient Centricity, G106

Sponsor presentation

Oct 812:20
Conference pass

Sponsor presentation

Digital Transformation, G107

Sponsor presentation

Oct 812:30
Conference pass

Optimizing DSUR processes in the face of regulatory and operational complexities

Risk Management, Exhibition Theatre 1
MUGDHA Chopra, Co-founder and Director, AWINSA Life Sciences
Oct 812:40
Conference pass

Advancing communication strategies in pharmacovigilance

Digital Transformation, G107
Ekaterina Edle von Dall'Armi, Local QPPV, Germany, GSK
Oct 812:40
Conference pass

AI in the VigiVerse PV Stack

Artificial Intelligence, Auditorium
Oct 812:40
Conference pass

Co-producing risk alerts for pharmacy software for patients with sight impairments

Risk Management 2, G105

Speaker presentation

Oct 812:40
Conference pass

Enhancing benefit-risk assessments with patient input: strategies and frameworks in drug development

Patient Centricity, G106
Shay Goldstein, Senior Director, Global Safety Lead Oncology, Bristol Myers Squibb
Oct 812:40
Conference pass

Follow up oversights: using automated systems to synchronize international oversight

Automation, G102
Janni Hermansen, Director, Head of Global Safety Operations, Ferring Pharmaceuticals A/S
Malene Nyboe Persson, Specialist Safety Officer, Ferring Pharmaceuticals A/S
Oct 812:40
Conference pass

Independent safety monitoring in clinical studies

Risk Management, Exhibition Theatre 1
Rudi Scheerlinck, Global Program Safety Lead, Merck Healthcare Oncology
Oct 812:40
Conference pass

Oversight of service providers

Outsourcing, G109
Sheela Ankolekar, Associate Director, Senior Pharmacovigilance Physician, Norgine Ltd
Oct 812:40
Conference pass

Safety database migration journey: experiences and lessons learned

Compliance, G104
Lourdes Diaz, Pharmacovigilance Senior Manager, Shionogi SBV
Oct 812:40
Conference pass

Safety review and challenge of adoptive cell therapy in cancer

Signal Detection & Management, Exhibition Theatre 2

Speaker presentation

Tarik Messaoud, Medical Director, Drug Safety Physician, Iovance Biotherapeutics
Oct 812:40
Conference pass

Standards for MAHs in local literature searches by The Polish Society of PV

Quality Assurance, G103
Anastazja Markowska, Director, Polish Society of Pharmacovigilance
Oct 813:00
Conference pass

Drug safety monitoring for DR-TB treatment in LMIC

Signal Detection & Management, Exhibition Theatre 2
Everdina Tiemersma, Senior Epidemiologist, KNCV Tuberculosis Foundation
Oct 813:00
Conference pass

Future fit QA… Taking quality beyond compliance figures & audit reports

Quality Assurance, G103

Sponsor presentation

Rebecca Webb, Senior Director, Safety, Medical and Regulatory Quality, AbbVie
Oct 813:00
Conference pass

Session Reserved for ClinChoice

Risk Management, Exhibition Theatre 1

Sponsor presentation

Oct 813:00
Conference pass

Sponsor presentation

Artificial Intelligence, Auditorium

Sponsor presentation

Oct 813:00
Conference pass

Sponsor presentation

Automation, G102

Sponsor presentation

Oct 813:00
Conference pass

Sponsor presentation

Risk Management 2, G105

Sponsor presentation

Oct 813:00
Conference pass

Sponsor presentation

Patient Centricity, G106

Sponsor presentation

Oct 813:00
Conference pass

Sponsor presentation

Digital Transformation, G107

Sponsor presentation

Oct 813:00
Conference pass

The BeOne journey of build-ing PV vendor oversight capabilities from scratch

Outsourcing, G109
Janice Byrd, Director, Global Patient Safety Vendor Oversight, BeOne Medicines
Oct 813:00
Conference pass

The need for a multi-stakeholder collaboration to modernize ICSR management

Compliance, G104
Samuel Wallis, Senior Director, Head of Case Management, Patient Safety, Bristol Myers Squibb
Oct 813:20
Conference pass

Lunch

Keynotes

Lunch options purchasable in the exhibition hall.

Oct 814:45
Conference pass

01 Regulatory Agency Panel – Enhancing global PV operations

Artificial Intelligence, Auditorium
Moderator: Myriam Salem, National Good Pharmacovigilance Practices Inspection Program Coordinator, Health Canada
Anthonius (Ton) de Boer, Chairman, CBG-MEB Medicines Evaluation Board
Elena Prokofyeva, Head of Drug Safety Unit, DG Post, FAMHP - Federal Agency for Medicines and Health Products in Belgium
Phil Tregunno, Deputy Director, Patient Safety Monitoring, MHRA
Evangelos Manolopoulos, Chairman, National Organization for Medicines
Oct 814:45
Conference pass

02 Automation Panel – Impacts of AI & automation on signal detection

Automation, G102
Moderator: Teodora Perger, Visiting Lecturer, King's College London
Sridhar Yeshamaina, Vice President, Global Patient Safety, Amneal Pharmaceuticals
Philip Jones, Senior Director, Disease Area Cluster Lead, CVMWH, Pfizer
Linda Härmark, Director, Drug Safety Research Unit
Ryan Walker, Assistant Professor, Clinical Pharmacy, University of Birmingham
Stéphanie Tcherny-Lessenot, Global Head, Benefit-Risk Evaluation, Sanofi
Oct 814:45
Conference pass

03 Risk Management Panel – QPPV oversight for risk minimization measures

Risk Management, Exhibition Theatre 1
Moderator: Joan D'souza, Local QPPV, Independent PV Expert
Moin Don, Lead, ISoP South Asia Chapter, ISoP
Maria Jose Reneses, Senior Director, Deputy EU QPPV & Head of PSMF Team, Takeda
Stefanie Amend-Mall, Director, Patient Safety HUB Europe, Sandoz
Gaetano Aiello, Senior Manager, PV System Excellence, Jazz Pharmaceuticals
Oct 814:45
Conference pass

04 Signal Detection & Management Panel – Strengthening signal management with real world data and evidence

Signal Detection & Management, Exhibition Theatre 2
Ivana Vranic, Director, Safety Risk Lead, Inflammation & Immunology, Pfizer
Marie-Laure Kürzinger, Head of Pharmacoepidemiology, General Medicine, Sanofi
Veronica Fjellstrom, Global Head, Pharmacovigilance and Patient Safety, Oncopeptides AB
Oct 814:45
Conference pass

05 Quality Assurance Panel – The changing landscape of PV inspections

Quality Assurance, G103
Moderator: Smruti Kothari, Associate Director, Global Patient Safety, Quality and Compliance, Regeneron
Amir Lahouegue, Director, Patient Safety & Cluster Lead, France & Benelux, AstraZeneca
Hadir Rostom, Independent PV Expert - Lecturer, Modern Sciences And Arts University
Dominic Nguyen-Van-Tam, Senior Pharmacovigilance Inspector, MHRA
Varun Dua, Founder and CEO, PV Analytica
Oct 814:45
Conference pass

07 Risk Management 2 Panel – Women in patient safety

Risk Management 2, G105
Alina Tudor, Global Head, Medical Evaluation and ICSR Review, Kyowa Kirin International
Catherine Pons, Affiliate Patient Safety Director, Roche
Wivina De Waele, Senior Director Europe, Global Markets Patient Safety, AstraZeneca
Karin Kempe, EU/UK QPPV, Karo Healthcare
Moderator: Michelle Motta Dardeno, Vice President, Head of Global Patient Safety, Aurinia
Oct 814:45
Conference pass

08 Patient Centricity Panel - Reserved for A-S Medication Solutions

Patient Centricity, G106

Panel discussion

Oct 814:45
Conference pass

09 Digital Transformation Panel – Module XVI Rev 3 – One Year on...

Digital Transformation, G107

Reserved for Transcelerate

Moderator: Delphine Saragoussi, Head of Pharmacoepidemiology, Vaccines, Patient Safety & Pharmacovigilance, Sanofi
Anna Konczak, EU QPPV, Polpharma
Nathan Rivers, Associate Director, Medical Safety, Oncology, Jazz Pharmaceuticals
Siva Kumar Buddha, Medical Director, Global Patient Safety, Amgen
Catherine Lambermont, Risk Management Head, Sanofi
Oct 814:45
Conference pass

Compliance Panel 6 – RESERVED FOR SPONSOR

Compliance, G104

RESERVED FOR SPONSOR

Oct 814:45
Conference pass

Outsourcing Panel 10 – Title TBC

Outsourcing, G109
Laura Paola Boga, Senior Director, Head of Global Pharmacovigilance, UK & EU QPPV, Dompé farmaceutici spa
Valentina Mancini, Senior Director, Pharmacovigilance, QPPV, Shionogi & TransCelerate
Daniela Marcozzi, Head of Corporate Clinical Safety, Pharmacovigilance and R&D Compliance, EU & UK QPPV, Fidia farmaceutici spa
Daria Giusi Rasà, Head of Corporate Pharmacovigilance, EU/UK QPPV, Alfasigma
Mirko Fedrigo, Head of Drug Safety Europe and Global PV Quality System, EU/UK QPPV, Italfarmaco
Oct 815:45
Conference pass

Chair's Remarks

Risk Management 2, G105

Chair's Remarks

Pedro Caetano, Senior Safety Physician, Debiopharm International
Oct 815:45
Conference pass

Chair's Remarks

Compliance, G104
Abiola David, Senior Director, Global Process Owner, ICSR Management, PV Operations, GSK
Oct 815:45
Conference pass

Chair's Remarks

Patient Centricity, G106

Chair's Remarks

Oct 815:45
Conference pass

Chair's Remarks

Digital Transformation, G107

Chair's Remarks

Oct 815:45
Conference pass
Oct 815:45
Conference pass

Chair's Remarks

Artificial Intelligence, Auditorium

Chair's Remarks

Oct 815:45
Conference pass

Chair's Remarks

Risk Management, Exhibition Theatre 1
Joan D'souza, Local QPPV, Independent PV Expert
Oct 815:45
Conference pass

Chair's Remarks

Signal Detection & Management, Exhibition Theatre 2
Oct 815:45
Conference pass

Chair's Remarks

Quality Assurance, G103
Moin Don, Lead, ISoP South Asia Chapter, ISoP
Oct 815:50
Conference pass

Artificial intelligence real time solutions in pharmacovigilance

Artificial Intelligence, Auditorium
Sridhar Yeshamaina, Vice President, Global Patient Safety, Amneal Pharmaceuticals
Oct 815:50
Conference pass

Benefit-risk methodologies for SMEs

Risk Management, Exhibition Theatre 1
Kieran O'Donnell, Director, Independent PV Expert
Prabjot Hunjan, DIRECTOR, Independent PV Expert
Oct 815:50
Conference pass

Digital adherence support in clinical trials

Digital Transformation, G107
Oct 815:50
Conference pass

Leveraging Brighton collaboration case definitions in safety risk management

Risk Management 2, G105
Oct 815:50
Conference pass

Non-interventional studies: challenges and improvements

Compliance, G104
Daniela Di Cosmo, Senior Safety Advisor, Global Safety, Ferring Pharmaceuticals
Oct 815:50
Conference pass

Safety considerations for patient support programmes

Quality Assurance, G103
Sergiy Kryvych, Senior Drug Safety Officer & Medical Advisor, Deputy Local Pharmacovigilance Responsible Person, Pfizer
Oct 815:50
Conference pass

The future of veterinary pharmacovigilance: regulatory updates

Signal Detection & Management, Exhibition Theatre 2
Blanca Berrocal Gonzalez, Head of Pharmacovigilance Compliance, Veterinary Medicines Directorate
Oct 815:50
Conference pass

The role of QPPVs in crisis management: navigating safety issues under force majeure conditions

Patient Centricity, G106
Galina Cordero, Head of Pharmacovigilance Department, QPPV, JSC Farmak
Oct 816:10
Conference pass

Session Reserved for RayCRO

Risk Management, Exhibition Theatre 1

Session Reserved for RayCRO

Oct 816:10
Conference pass

Sponsor presentation

Artificial Intelligence, Auditorium

Sponsor presentation

Oct 816:10
Conference pass

Sponsor presentation

Signal Detection & Management, Exhibition Theatre 2

Sponsor presentation

Oct 816:10
Conference pass

Sponsor presentation

Quality Assurance, G103

Sponsor presentation

Oct 816:10
Conference pass

Sponsor presentation

Compliance, G104

Sponsor presentation

Oct 816:10
Conference pass

Sponsor presentation

Risk Management 2, G105

Sponsor presentation

Oct 816:10
Conference pass

Sponsor presentation

Patient Centricity, G106

Sponsor presentation

Oct 816:10
Conference pass

Sponsor presentation

Digital Transformation, G107

Sponsor presentation

Oct 816:10
Conference pass

Sponsor presentation

Outsourcing, G109

Sponsor presentation

Oct 816:30
Conference pass

A risk-based approach to pharmacovigilance audits - automation of risk assessments

Quality Assurance, G103
Oct 816:30
Conference pass

Benefits of cooperation with marketing authorisation holders during DHPC distributions

Risk Management, Exhibition Theatre 1
Anna Konczak, EU QPPV, Polpharma
Oct 816:30
Conference pass

CHIRON: Roche’s safety knowledge repository

Artificial Intelligence, Auditorium
Sriram Venkateswaran, Safety Data Science Director, Hoffmann la Roche Ltd
Oct 816:30
Conference pass

DRMP in Oncology Clinical Trials

Risk Management 2, G105

Speaker presentation

Pedro Caetano, Senior Safety Physician, Debiopharm International
Oct 816:30
Conference pass

Pharmacovigilance in Latin America: navigating regulatory complexity and building collaborative solutions

Compliance, G104

Speaker presentation

Roma Dhaia, Senior Manager, Regulatory Affairs, Geographic Expansion, Jazz Pharmaceuticals
Oct 816:30
Conference pass

Speaker presentation

Signal Detection & Management, Exhibition Theatre 2

Speaker presentation

Oct 816:30
Conference pass

Speaker presentation

Patient Centricity, G106

Speaker presentation

Oct 816:30
Conference pass

Speaker presentation

Digital Transformation, G107

Speaker presentation

Oct 816:30
Conference pass

Speaker presentation

Outsourcing, G109

Speaker presentation

Oct 816:50
Conference pass

Close of conference

Keynotes

Close of conference

last published: 17/Sep/25 13:15 GMT

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