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
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
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
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

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

Incorporating patient safety risk review into the governance process for digital assets

Digital Transformation
Harminder Mudhar, Director, Device & Digital Safety, AstraZeneca
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, Safety Science Partner and Global Business Lead, 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
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
Mohammed Ali Kotal, EU QPPV and Head of QPPV Office, Sandoz International GmbH
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
Rachel Wallace, Associate Director Drug Safety & PV, Deputy QPPV, Insmed Incorporated
Zoe Hamill, GPvP Inspector, MHRA
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 Switzerland
John Solomon, Head of Pharmacovigilance, UK & Ireland, SANOFI
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
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

Creating a roadmap for digital transformation in safety at Ipsen

Digital Transformation
Fabrice Besle, Head of Technology and Digital, Global Patient Safety, Ipsen
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

New regulatory updates for software as a medical device: SaMD

Medical Devices
Ben Kitchens, Associate Director, Medical Devices, Diagnostics Lead, Otsuka Pharmaceutical Companies (U.S.)
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 centric approaches to cell and gene therapies

Patient Centricity
Akhilesh Chamediya, Global Medical Director, Patient Safety Lead, AstraZeneca & Alexion
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

Speaker presentation - AXIAN

Risk Management

Session reserved for AXIAN.

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

Patient Centricity

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

Sponsor presentation

Artificial Intelligence

Sponsor presentation

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

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, Vice President, Safety & Pharmacovigilance, 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

Follow up and risk management

Risk Management 2
Barbara Dawson, Vice President, Head of Pharmacovigilance Operations, GSK
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 812:20
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
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

Signal Detection & Management

Sponsor presentation

Oct 813:00
Conference pass

Sponsor presentation

Quality Assurance

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, 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
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
Moderator: Anna Pelnikevich, Director, Head of QPPV Office, Merck
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

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
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

Chair's Remarks

Signal Detection & Management
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

Challenges for vendor over-sight from smaller company perspectives

Outsourcing
Petra Schmid, Team Lead Drug Safety, Deputy EU QPPV, AOP Health GmbH
Oct 815:50
Conference pass

Developing system standards across the PV industry

Digital Transformation
Thomas Kuckuk, Head, Pharmacovigilance Systems Management, Novartis
Oct 815:50
Conference pass

Leveraging Brighton collaboration case definitions in safety risk management

Risk Management 2
Christos Goulas, Senior Manager, Safety Risk Lead (SRL), Pfizer
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

Flexibility in outsourcing models for CROs and boutique vendors

Outsourcing
Christopher Flood, Executive Director, Global Patient Safety Operations, Revolution Medicines
Oct 816:30
Conference pass

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

Compliance
Rebecca Webb, Senior Director, Safety, Vigilance and Medical Affairs QA, AbbVie
Oct 816:30
Conference pass

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

Digital Transformation
Anders Thyme, Director, Pharmacovigilance, Ascendo
Oct 816:30
Conference pass

Signal detection for orphan diseases

Signal Detection & Management
Alexandru Barbarosie, EU/UK QPPV, Global Safety Lead, Amryt Pharma
Oct 816:30
Conference pass

Speaker presentation

Risk Management 2

Speaker presentation

Oct 816:30
Conference pass

Speaker presentation

Patient Centricity

Speaker presentation

Oct 816:50
Conference pass

Close of conference

Keynotes

Close of conference

last published: 25/Jun/25 12:25 GMT

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