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
Session Reserved for ArisGlobal
Keynotes
Reserved for ArisGlobal
Oct 79:40
Conference pass
Session Reserved for Sandoz
Keynotes
Shaloo Pandhi, Global Head, Patient Safety, Sandoz
Oct 710:00
Conference pass
Session Reserved for Veeva
Keynotes
Session Reserved for Veeva
Oct 710:20
Conference pass
Keynote presentation
Keynotes
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
Chair's Remarks
Artificial Intelligence
Oct 711:55
Conference pass
Chair's Remarks
Automation
Oct 711:55
Conference pass
Oct 711:55
Conference pass
Chair's Remarks
Signal Detection & Management
Fabian Heisig, Chief Medical Officer, Senior Vice President, Head Global Drug Safety & QPPV, Grunenthal
Oct 711:55
Conference pass
Chair's Remarks
Quality Assurance
Dany Ward, Executive Director, Head of PV Ops & Global Risk Management, Jazz Pharmaceuticals
Oct 711:55
Conference pass
Chair's Remarks
Compliance
Gloria Bustos, Global Head Global Patient Safety, Vantive
Oct 711:55
Conference pass
Chair's Remarks
Medical Devices
Chair's Remarks
Oct 711:55
Conference pass
Chair's Remarks
Patient Centricity
Yvonne Nanciu, Country Head, Pharmacovigilance, Deputy EU QPPV, Bayer
Oct 711:55
Conference pass
Chair's Remarks
Outsourcing
Rita Lobatto, Vice President, Pharmacovigilance & QPPV, Pharming Group
Oct 712:00
Conference pass
Advancing automation in aggregate reports
Automation
Israel Gutierrez, Chief Medical Officer, TLR Therapeutics Inc
Oct 712:00
Conference pass
AI & real-world data in signal management: rare diseases and beyond
Artificial Intelligence
Michael von Forstner, Clinical Development Leader, Crearene AG
Oct 712:00
Conference pass
Developing system standards across the PV industry
Digital Transformation
Thomas Kuckuk, Head, Pharmacovigilance Systems Management, Novartis
Oct 712:00
Conference pass
Implementation and reporting requirements for medical devices in the EU AI Act
Medical Devices
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
Barbara Bovy, Director, Head of Quality Intelligence, UCB
Oct 712:00
Conference pass
Patient perspectives in the design of next generation medicines
Patient Centricity
Fabio Lievano, Vice President, Safety Science, AbbVie
Oct 712:00
Conference pass
Safety strategy and benefit risk
Risk Management
Chris Bone, Director, Safety and Benefit Risk, Biogen
Oct 712:00
Conference pass
Signal management for gene therapies
Signal Detection & Management
Asif Mahmood, Vice President, Medical Safety & Pharmacovigilance, AskBio
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
Begum Benli Peker, Director, Head of Patient Safety Netherlands & EU Hub Lead, Bristol Myers Squibb
Oct 712:00
Conference pass
What does a mid-sized pharma really need from its PV vendor?
Outsourcing
Howard Snow, Vice President, Global Head of Pharmacovigilance, Sobi (Swedish Orphan Biovitrum)
Oct 712:20
Conference pass
Session Reserved for Arriello
Outsourcing
Session Reserved for Arriello
Oct 712:20
Conference pass
Session Reserved for COD Research
Risk Management
Session Reserved for COD Research
Oct 712:20
Conference pass
Session Reserved for EVERSANA
Patient Centricity
Session Reserved for EVERSANA
Oct 712:20
Conference pass
Session Reserved for Indegene
Artificial Intelligence
Session Reserved for Indegene
Oct 712:20
Conference pass
Session Reserved for Pinnaxis
Automation
Session Reserved for Pinnaxis
Oct 712:20
Conference pass
Session Reserved for ProductLife Group
Compliance
Session Reserved for ProductLife Group
Oct 712:20
Conference pass
Session Reserved for Qinecsa
Signal Detection & Management
Session Reserved for Qinecsa
Oct 712:20
Conference pass
Session Reserved for RiverArk
Quality Assurance
Session Reserved for RiverArk
Oct 712:20
Conference pass
Session Reserved for Syneos Health
Digital Transformation
Session Reserved for Syneos Health
Oct 712:20
Conference pass
Sponsor presentation
Medical Devices
Sponsor presentation
Oct 712:40
Conference pass
Automated semi-quantitative signal detection
Signal Detection & Management
Oct 712:40
Conference pass
Creating collaborative data spaces for patient safety
Digital Transformation
Jost Leemhuis, Patient Safety, Roche
Oct 712:40
Conference pass
Early strategies for risk management in clinical trials
Risk Management
Oct 712:40
Conference pass
Evolving and diversifying hyper automation practice in pharmacovigilance
Automation
Karthick Sukumaran, Director, Technology Enablement, Intelligent Safety Automation, Roche Products Ltd
Oct 712:40
Conference pass
Governance for the future of AI in the PV industry
Artificial Intelligence
Oct 712:40
Conference pass
How outsourcing plays a critical role in optimizing the affiliate pharmacovigilance structure
Outsourcing
Oct 712:40
Conference pass
Implementation of safety variations to fulfil cross-functional compliance requirements
Compliance
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
Shanti Werther, Executive Director, Global Safety Head, Immunology Patient Safety, Biopharma, AstraZeneca
Oct 712:40
Conference pass
Partnering for successful inspections
Quality Assurance
Natalia Quintana, Associate Director, GPV Performance Excellence, Kyowa Kirin
Oct 712:40
Conference pass
The role of medical doctors in risk management for medical devices
Medical Devices
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
Session Reserved for ALWIS
Digital Transformation
Session Reserved for ALWIS
Oct 713:00
Conference pass
Session Reserved for ArisGlobal
Artificial Intelligence
Session Reserved for ArisGlobal
Oct 713:00
Conference pass
Session Reserved for DeltaPV
Patient Centricity
Session Reserved for DeltaPV
Oct 713:00
Conference pass
Session Reserved for Orbit by Feith Systems
Risk Management
Session Reserved for Orbit by Feith Systems
Oct 713:00
Conference pass
Session Reserved for Parexel
Signal Detection & Management
Session Reserved for Parexel
Oct 713:00
Conference pass
Session Reserved for Soterius
Outsourcing
Session Reserved for Soterius
Oct 713:00
Conference pass
Sponsor presentation
Compliance
Sponsor presentation
Oct 713:00
Conference pass
Sponsor presentation
Medical Devices
Sponsor presentation
Oct 713:00
Conference pass
Sponsor Presentation
Quality Assurance
Sponsor Presentation
Oct 713:00
Conference pass
The role of Agentic AI in PV automation
Automation
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
Reserved for Primevigilance
Oct 714:45
Conference pass
02 Automation Panel - Reserved for ArisGlobal
Automation
Reserved for ArisGlobal
Oct 714:45
Conference pass
03 Risk Management Panel - Implementing benefit-risk frameworks: engaging patients and new tools
Risk Management
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
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
Heinz Weidenthaler, Senior Director, Safety Strategy Lead, Biontech
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
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
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
Sarah Vaughan, Head of Vigilance Operations, MHRA
Omar Aimer, Executive Member of ISoP and NASoP President, International Society of Pharmacovigilance (ISoP)
Judy Barretto, Senior Director, Virology TA, Patient Safety, Gilead
Oct 714:45
Conference pass
08 Patient Centricity Panel – Advancing patient centered risk minimization measures
Patient Centricity
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 – Reserved for Ultragenic
Digital Transformation
Reserved for Ultragenic
Oct 714:45
Conference pass
10 Outsourcing Panel – Vendor oversight: challenges and opportunities for PV outsourcing
Outsourcing
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
Nibedita Rath, Scientific Director, Open Source Pharma Foundation
Oct 715:45
Conference pass
Chair's Remarks
Automation
Attila Oláh, Vice President, Head, Global Patient Safety, EU-QPPV, Gedeon Richter PLC
Oct 715:45
Conference pass
Chair's Remarks
Signal Detection & Management
Chair's Remarks
Ana Sofia Afonso, Director, Pharmacoepidemiology, Global Patient Safety, Eli Lilly
Oct 715:45
Conference pass
Chair's Remarks
Quality Assurance
Tanja Hoffman, Owner, Executive Consultant, Independent PV Expert
Oct 715:45
Conference pass
Chair's Remarks
Compliance
Minhaj Obeidullah, Global Head, Governance & Risk, Novartis
Oct 715:45
Conference pass
Chair's Remarks
Medical Devices
Chair's Remarks
Sujith Madhavan, Medical Director, Pharmacovigilance, Jazz Pharmaceuticals
Oct 715:45
Conference pass
Chair's Remarks
Patient Centricity
Eveline Schurink, Vice President, Clinical Development, Patient Safety & Medical Affairs, Alvotech
Oct 715:45
Conference pass
Chair's Remarks
Digital Transformation
Ariane Stollenwerk, Director, Head of Safety Central Europe & APAC, UCB
Oct 715:45
Conference pass
Chair's Remarks
Outsourcing
Mina G Awad, Pharmacovigilance Senior Manager and QPPV, Middle East, Kyowa Kirin International
Oct 715:45
Conference pass
Chair's Remarks - AXIAN
Risk Management
Chair's Remarks
Oct 715:50
Conference pass
Advancing signal detection with social media listening
Signal Detection & Management
Marco Tuccori, Associate Professor of Pharmacology, Department of Diagnostic & Public Health, University of Verona
Oct 715:50
Conference pass
Building relationships in outsourcing: lessons learned
Outsourcing
Mark Cawley, Associate Director, R&D Procurement, Jazz Pharmaceuticals
Oct 715:50
Conference pass
Fostering end-to-end collaboration between regulatory and safety organisations for Safety Issue Notification
Compliance
Aya Zaghloul, Associate Director, GPS International Pharmacovigilance Operations, Eli Lilly and Company
Oct 715:50
Conference pass
Incorporating AI generated cases into databases: supported by human quality control
Artificial Intelligence
Oct 715:50
Conference pass
Optimal prompt strategies and selection of biomedical LLMs for causality assessment
Automation
Maurizio Sessa, Associate Professor, Pharmacovigilance and Pharmacoepidemiology, University of Copenhagen
Oct 715:50
Conference pass
Patient centricity: a QPPV office perspective
Patient Centricity
Speaker presentation
Oct 715:50
Conference pass
PMDA inspections: CRO oversight
Quality Assurance
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
Anders Thyme, Director, Pharmacovigilance, Ascendo
Oct 715:50
Conference pass
Speaker presentation
Medical Devices
Speaker presentation
Oct 715:50
Conference pass
Speaker presentation - AXIAN
Risk Management
Session reserved for AXIAN.
Oct 716:10
Conference pass
Evolving regulatory landscape for advanced therapies: navigating clinical safety and pharmacovigilance
Patient Centricity
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
Graeme Ladds, CEO, PharSafer
Oct 716:10
Conference pass
Session Reserved for AXIAN
Risk Management
Session Reserved for AXIAN
Oct 716:10
Conference pass
Session Reserved for Nextrove
Digital Transformation
Session Reserved for Nextrove
Oct 716:10
Conference pass
Session Reserved for Nextrove
Digital Transformation
Session Reserved for Nextrove
Oct 716:10
Conference pass
Session Reserved for Ultragenic
Artificial Intelligence
Session Reserved for Ultragenic
Oct 716:10
Conference pass
Sponsor presentation
Signal Detection & Management
Sponsor presentation
Oct 716:10
Conference pass
Sponsor presentation
Quality Assurance
Sponsor presentation
Oct 716:10
Conference pass
Sponsor presentation
Compliance
Sponsor presentation
Oct 716:10
Conference pass
Sponsor presentation
Medical Devices
Sponsor presentation
Oct 716:10
Conference pass
Sponsor presentation
Outsourcing
Sponsor presentation
Oct 716:30
Conference pass
Advancing AI in medical devices & QMS usage of AI
Medical Devices
Ryan Magee, Founder & Vice President of Engineering, IMPAQT Engineering
Oct 716:30
Conference pass
AI in action: an AI-powered approach to literature screening
Artificial Intelligence
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
Sarah Tarnowsky, PSMF Coordinator & Specialist Quality Management, Viatris
Oct 716:30
Conference pass
Processing BOTs in Pfizer - production experience
Automation
Magda Godula, Director, Regional Safety Platform Lead, Pfizer
Oct 716:30
Conference pass
PV obligation assistance tool for organised data collection
Digital Transformation
Oct 716:30
Conference pass
Signal detection: pattern recognition and value of single cases
Signal Detection & Management
Marija Stupar, Senior Director, Head Safety & Benefit Risk, Opioids and Generics, Grünenthal GmbH
Oct 716:30
Conference pass
Speaker presentation - AXIAN
Risk Management
Speaker presentation - AXIAN
Oct 716:30
Conference pass
Supplier performance management: building sustainable and strategic partnerships at Bayer
Outsourcing
Paul Hoericke, Global Procurement Category Lead PV, Bayer AG
Oct 716:30
Conference pass
Translating GVP Module XVI into patient outcomes: effectiveness of risk minimization measures
Patient Centricity
Oct 716:50
Conference pass
Networking Break
Keynotes
Networking break in the exhibition hall.
Oct 717:20
Conference pass
Chair's Remarks
Artificial Intelligence
Yvonne Schäfer, Head of Patient Safety and Pharmacovigilance Systems Business Solutions, Boehringer Ingelheim International
Oct 717:20
Conference pass
Chair's Remarks
Automation
Chair's Remarks
Vivienne van de Walle, Medical Director, P.T. and R
Oct 717:20
Conference pass
Chair's Remarks
Risk Management
Nisha Vora, Senior Safety Scientist, Global Patient Safety, Ipsen
Oct 717:20
Conference pass
Chair's Remarks
Signal Detection & Management
Natacha Carragher, Senior Advisor, Pharmacoepidemiology, Global Patient Safety, Eli Lilly
Oct 717:20
Conference pass
Chair's Remarks
Quality Assurance
Elena Keller, Director, PV, RA, Quality and Medical Operations, Local QPPV, Ipsen Pharma GmbH
Oct 717:20
Conference pass
Chair's Remarks
Compliance
Chair's Remarks
Oct 717:20
Conference pass
Chair's Remarks
Medical Devices
Chair's Remarks
Oct 717:20
Conference pass
Chair's Remarks
Patient Centricity
Chair's Remarks
Jamal Baig, Director, Pharmacovigilance, Country Safety Head, SANOFI
Oct 717:20
Conference pass
Chair's Remarks
Digital Transformation
Chair's Remarks
Oct 717:20
Conference pass
Chair's Remarks
Outsourcing
Chair's Remarks
Tina Ho, Senior Director, Vendor Relationship Management, Regeneron Pharmaceuticals Inc.
Oct 717:25
Conference pass
AI chatbots for treatment support and clinical decision making
Artificial Intelligence
Oct 717:25
Conference pass
Sponsor presentation
Automation
Sponsor presentation
Oct 717:25
Conference pass
Sponsor presentation
Risk Management
Sponsor presentation
Oct 717:25
Conference pass
Sponsor presentation
Signal Detection & Management
Sponsor presentation
Oct 717:25
Conference pass
Sponsor presentation
Quality Assurance
Sponsor presentation
Oct 717:25
Conference pass
Sponsor presentation
Compliance
Sponsor presentation
Oct 717:25
Conference pass
Sponsor presentation
Medical Devices
Sponsor presentation
Oct 717:25
Conference pass
Sponsor presentation
Patient Centricity
Sponsor presentation
Oct 717:25
Conference pass
Sponsor presentation
Digital Transformation
Sponsor presentation
Oct 717:25
Conference pass
Sponsor presentation
Outsourcing
Sponsor presentation
Oct 717:45
Conference pass
Advancing local patient safety perspectives in PV regulations
Patient Centricity
Antonella Fretta, Senior Director, Aggregate Reporting Team Lead, PFIZER
Oct 717:45
Conference pass
As exploitant, how are we best prepared for a French PV inspection?
Quality Assurance
Agnès Barrere, Local QPPV (RPV), France, Otsuka Pharmaceutical
Oct 717:45
Conference pass
Challenges and pitfalls of automation in smaller companies
Automation
Johanna Strandell, Director, Patient Safety, Camurus AB
Oct 717:45
Conference pass
Managing PV system transformation from a business perspective
Digital Transformation
Pawel Chomiak, Associate Director, Clinical Data Management, MSD
Monika Sarnecka, Associate Director, Clinical Data Management, MSD
Oct 717:45
Conference pass
Medical safety databases and challenges with outsourcing
Outsourcing
Anand Ananthakrishnan, Senior Director, Drug Safety and Pharmacovigilance, Blueprint Medicines
Oct 717:45
Conference pass
Pharmacovigilance for OTC products: similarities and differences
Compliance
Rafael Josupeit, EEA QPPV, Procter & Gamble
Oct 717:45
Conference pass
Practical application of artificial intelligence from a safety physician perspective
Artificial Intelligence
Oct 717:45
Conference pass
Risk minimization communication in non-EU countries
Risk Management
Marjan Dzeparoski, RA and PV Manager, Bionika Pharmaceuticals
Oct 717:45
Conference pass
Signal detection for orphan diseases
Signal Detection & Management
Alexandru Barbarosie, EU/UK QPPV, Global Safety Lead, Amryt Pharma
Oct 717:45
Conference pass
Speaker presentation
Medical Devices
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
Title TBC
Keynotes
Bruce Palsulich, Strategic Client Advisor, 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
Serban Ghiorghiu, Chief Safety Officer, AstraZeneca
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
Claudia Lehmann, Vice President, Head, Patient Safety & Pharmacovigilance Operations, Boehringer Ingelheim International
Oct 811:55
Conference pass
Chair's Remarks
Automation
Chair's remarks
Uwe Gudat, Chief Medical Officer, Biocon Biologics
Oct 811:55
Conference pass
Chair's Remarks
Risk Management
Peter Kohut, Senior Director, Head of Pharmacovigilance, Alvotech
Oct 811:55
Conference pass
Chair's Remarks
Signal Detection & Management
Krupa Patel, Senior Safety Scientist, Global Patient Safety, Ipsen
Oct 811:55
Conference pass
Chair's Remarks
Quality Assurance
Tina Wirstrom, Director, EU QPPV Office, Takeda
Oct 811:55
Conference pass
Chair's Remarks
Compliance
Wasim Anwar, Vice President, Head of QPPV Office, Novo Nordisk A/S
Oct 811:55
Conference pass
Chair's Remarks
Risk Management 2
David Chonzi, Independent Pharma Physician, Independent PV Expert
Oct 811:55
Conference pass
Chair's Remarks
Patient Centricity
Deepa Venkataraman, Vice President, Patient Safety and Pharmacovigilance, Corcept Therapeutics
Oct 811:55
Conference pass
Chair's Remarks
Digital Transformation
Chair's Remarks
Oct 811:55
Conference pass
Chair's Remarks
Outsourcing
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
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
Oct 812:00
Conference pass
Applying the key principles of pharmacovigilance for consumer healthcare products
Patient Centricity
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
Stéphanie Tcherny-Lessenot, Global Head, Benefit-Risk Evaluation, Sanofi
Oct 812:00
Conference pass
Digital innovations at Pfizer to build efficient safety organisations
Digital Transformation
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
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
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
Simon Ashworth, Global Head of Safety, Menarini
Oct 812:00
Conference pass
Quality control of automated systems in case management and safety reporting
Automation
Tuula Ikonen, Head of Pharmacovigilance Department, EORTC
Oct 812:00
Conference pass
Registry studies and real-world evidence for rare diseases
Risk Management 2
Carolina Buitrago, Medical Director, Global Patient Safety, AstraZeneca & Alexion
Oct 812:20
Conference pass
Generative to agentic AI: multiplying PV writing impact
Artificial Intelligence
Ikram Baig, CEO, Quartica
Oct 812:20
Conference pass
Key approaches to strengthening patient safety through effective risk management plan controls
Risk Management
Sanjeev Miglani, Founder and Director, AWINSA Life Sciences
Oct 812:20
Conference pass
Session Reserved for Baupharma
Outsourcing
Session Reserved for Baupharma
Oct 812:20
Conference pass
Sponsor presentation
Automation
Sponsor presentation
Oct 812:20
Conference pass
Sponsor presentation
Signal Detection & Management
Sponsor presentation
Oct 812:20
Conference pass
Sponsor presentation
Quality Assurance
Sponsor presentation
Oct 812:20
Conference pass
Sponsor presentation
Compliance
Sponsor presentation
Oct 812:20
Conference pass
Sponsor presentation
Risk Management 2
Sponsor presentation
Oct 812:20
Conference pass
Sponsor presentation
Patient Centricity
Sponsor presentation
Oct 812:20
Conference pass
Sponsor presentation
Digital Transformation
Sponsor presentation
Oct 812:30
Conference pass
Optimizing DSUR processes in the face of regulatory and operational complexities
Risk Management
Mugdha Chopra, Co-founder and Director, AWINSA Life Sciences
Oct 812:40
Conference pass
Advancing communication strategies in pharmacovigilance
Digital Transformation
Ekaterina Edle von Dall'Armi, Local QPPV, Germany, GSK
Oct 812:40
Conference pass
Co-producing risk alerts for pharmacy software for patients with sight impairments
Risk Management 2
Speaker presentation
Lisa Riste, Research Fellow, NIHR Greater Manchester Patient Safety Centre, University of Manchester
Oct 812:40
Conference pass
Enhancing benefit-risk assessments with patient input: strategies and frameworks in drug development
Patient Centricity
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
Janni Hermansen, Director, Head of Global Safety Operations, Ferring Pharmaceuticals A/S
Oct 812:40
Conference pass
Independent safety monitoring in clinical studies
Risk Management
Rudi Scheerlinck, Global Program Safety Lead, Merck Healthcare Oncology
Oct 812:40
Conference pass
Oversight of service providers
Outsourcing
Sheela Ankolekar, Associate Director, Senior Pharmacovigilance Physician, Norgine Ltd
Oct 812:40
Conference pass
Setting up effective PVA end to end processes
Compliance
Lourdes Diaz, Pharmacovigilance Senior Manager, Shionogi SBV
Oct 812:40
Conference pass
Signal management in phase 1 trials
Signal Detection & Management
Oct 812:40
Conference pass
Standards for MAHs in local literature searches by The Polish Society of PV
Quality Assurance
Anastazja Markowska, Director, Polish Society of Pharmacovigilance
Oct 812:40
Conference pass
Title TBC
Artificial Intelligence
Oct 813:00
Conference pass
Drug safety monitoring for DR-TB treatment in LMIC
Signal Detection & Management
Mansa Mbenga, Team Lead: Treatment & Care, KNCV Tuberculosis Foundation
Everdina Tiemersma, Senior Epidemiologist, KNCV Tuberculosis Foundation
Oct 813:00
Conference pass
Future fit QA… Taking quality beyond compliance figures & audit reports
Quality Assurance
Sponsor presentation
Rebecca Webb, Senior Director, Safety, Medical and Regulatory Quality, AbbVie
Oct 813:00
Conference pass
Session Reserved for ClinChoice
Risk Management
Sponsor presentation
Oct 813:00
Conference pass
Sponsor presentation
Artificial Intelligence
Sponsor presentation
Oct 813:00
Conference pass
Sponsor presentation
Compliance
Sponsor presentation
Oct 813:00
Conference pass
Sponsor presentation
Automation
Sponsor presentation
Oct 813:00
Conference pass
Sponsor presentation
Risk Management 2
Sponsor presentation
Oct 813:00
Conference pass
Sponsor presentation
Patient Centricity
Sponsor presentation
Oct 813:00
Conference pass
Sponsor presentation
Digital Transformation
Sponsor presentation
Oct 813:00
Conference pass
The BeOne journey of build-ing PV vendor oversight capabilities from scratch
Outsourcing
Janice Byrd, Director, Global Patient Safety Vendor Oversight, BeOne Medicines
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
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
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
Juhaeri Juhaeri, Vice President & Global Head, Epidemiology and Benefit-Risk, Sanofi
Linda Härmark, Director, Drug Safety Research Unit
Ryan Walker, Assistant Professor, Clinical Pharmacy, University of Birmingham
Oct 814:45
Conference pass
03 Risk Management Panel – QPPV oversight for risk minimization measures
Risk Management
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
Delphine BERTRAM, Senior Director, EU QPPV, Pharming
Oct 814:45
Conference pass
04 Signal Detection & Management Panel – Strengthening signal management with real world data and evidence
Signal Detection & Management
Ivana Vranic, Director, Safety Risk Lead, Inflammation & Immunology, Pfizer
Marie-Laure Kürzinger, Head of Pharmacoepidemiology, General Medicine, Sanofi
Danielle Middleton, Director, Safety Physician, Jazz Pharmaceuticals
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
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
Oct 814:45
Conference pass
07 Risk Management 2 Panel – Women in patient safety
Risk Management 2
Michelle Motta Dardeno, Vice President, Head of Global Patient Safety, Aurinia
Alina Tudor, Global Head, Medical Evaluation and ICSR Review, Kyowa Kirin International
Rania Haggag, Associate Director, Pharmacovigilance Strategy and Business Excellence, Organon
Catherine Pons, Affiliate Patient Safety Director, Roche
Oct 814:45
Conference pass
08 Patient Centricity Panel - Reserved for A-S Medication Solutions
Patient Centricity
Panel discussion
Oct 814:45
Conference pass
09 Digital Transformation Panel – Module XVI Rev 3 – One Year on...
Digital Transformation
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
Oct 814:45
Conference pass
Compliance Panel 6 – RESERVED FOR SPONSOR
Compliance
RESERVED FOR SPONSOR
Oct 814:45
Conference pass
Outsourcing Panel 10 – Title TBC
Outsourcing
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
Chair's Remarks
Pedro Caetano, Senior Safety Physician, Debiopharm International
Oct 815:45
Conference pass
Chair's Remarks
Compliance
Abiola David, Senior Director, Global Process Owner, ICSR Management, PV Operations, GSK
Oct 815:45
Conference pass
Chair's Remarks
Patient Centricity
Chair's Remarks
Oct 815:45
Conference pass
Chair's Remarks
Digital Transformation
Chair's Remarks
Oct 815:45
Conference pass
Chair's Remarks
Outsourcing
Chair's Remarks
Oct 815:45
Conference pass
Chair's Remarks
Artificial Intelligence
Chair's Remarks
Ranga Reddy, Independent AI Expert
Oct 815:45
Conference pass
Chair's Remarks
Risk Management
Joan D'souza, Local QPPV, Independent PV Expert
Oct 815:45
Conference pass
Oct 815:45
Conference pass
Chair's Remarks
Quality Assurance
Moin Don, Lead, ISoP South Asia Chapter, ISoP
Oct 815:45
Conference pass
TransCelerate Panel Discussion - From replication to reinvention: a path to de-centralized, collaborative ICSR management
Automation
Moderator: Samuel Wallis, Senior Director, Head of ICSR Case Processing, World Wide Patient Safety Operations, Bristol Myers Squibb
Oct 815:50
Conference pass
Artificial intelligence real time solutions in pharmacovigilance
Artificial Intelligence
Sridhar Yeshamaina, Vice President, Global Patient Safety, Amneal Pharmaceuticals
Oct 815:50
Conference pass
Benefit-risk methodologies for SMEs
Risk Management
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
Kristian van Kalmthout, Digital Health Consultant, KNCV Tuberculosis Foundation
Oct 815:50
Conference pass
Flexibility in outsourcing models for CROs and boutique vendors
Outsourcing
Christopher Flood, Executive Director, Global Patient Safety Operations, Revolution Medicines
Oct 815:50
Conference pass
Leveraging Brighton collaboration case definitions in safety risk management
Risk Management 2
Oct 815:50
Conference pass
Non-interventional studies: challenges and improvements
Compliance
Daniela Di Cosmo, Senior Safety Advisor, Global Safety, Ferring Pharmaceuticals
Oct 815:50
Conference pass
Safety considerations for patient support programmes
Quality Assurance
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
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
Galina Cordero, Head of Pharmacovigilance Department, QPPV, JSC Farmak
Oct 816:10
Conference pass
Session Reserved for RayCRO
Risk Management
Session Reserved for RayCRO
Oct 816:10
Conference pass
Sponsor presentation
Artificial Intelligence
Sponsor presentation
Oct 816:10
Conference pass
Sponsor presentation
Signal Detection & Management
Sponsor presentation
Oct 816:10
Conference pass
Sponsor presentation
Quality Assurance
Sponsor presentation
Oct 816:10
Conference pass
Sponsor presentation
Compliance
Sponsor presentation
Oct 816:10
Conference pass
Sponsor presentation
Risk Management 2
Sponsor presentation
Oct 816:10
Conference pass
Sponsor presentation
Patient Centricity
Sponsor presentation
Oct 816:10
Conference pass
Sponsor presentation
Digital Transformation
Sponsor presentation
Oct 816:10
Conference pass
Sponsor presentation
Outsourcing
Sponsor presentation
Oct 816:30
Conference pass
A risk-based approach to pharmacovigilance audits - automation of risk assessments
Quality Assurance
Oct 816:30
Conference pass
Benefits of cooperation with marketing authorisation holders during DHPC distributions
Risk Management
Anna Konczak, EU QPPV, Polpharma
Oct 816:30
Conference pass
CHIRON: Roche’s safety knowledge repository
Artificial Intelligence
Sriram Venkateswaran, Safety Data Science Director, Hoffmann la Roche Ltd
Oct 816:30
Conference pass
DRMP in Oncology Clinical Trials
Risk Management 2
Speaker presentation
Pedro Caetano, Senior Safety Physician, Debiopharm International
Oct 816:30
Conference pass
Speaker presentation
Signal Detection & Management
Speaker presentation
Oct 816:30
Conference pass
Speaker presentation
Compliance
Speaker presentation
Oct 816:30
Conference pass
Speaker presentation
Patient Centricity
Speaker presentation
Oct 816:30
Conference pass
Speaker presentation
Digital Transformation
Speaker presentation
Oct 816:30
Conference pass
Speaker presentation
Outsourcing
Speaker presentation
Oct 816:50
Conference pass
Close of conference
Keynotes
Close of conference
last published: 17/Jul/25 14:25 GMT
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