AGENDA
Amsterdam, 4 - 5 October 2023
Schedule
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Oct 48:55
Conference pass
Chair's Remarks
Keynotes
Karsten Lollike, Corporate Vice President, QPPV, Novo Nordisk
Oct 49:00
Conference pass
Key considerations for how to effectively manage the safety oversight of cross-sector combination product solutions
Keynotes
Ira Solomon, Chief Safety Officer, Innovation, Johnson & Johnson
Oct 49:20
Conference pass
The transformative safety platform that puts the patient at the center for an integrated patient experience
Keynotes
Beena Wood, Senior Vice President, Safety & Medical Affairs Product Management, ArisGlobal LLC
Oct 49:40
Conference pass
Complexities and learnings from PV system transformation
Keynotes
Shaloo Pandhi, Senior Vice President, Global Head, Patient Safety, Sandoz
Oct 410:00
Conference pass
Large language models and generative AI: implications and opportunities for pharmacovigilance
Keynotes
Oct 410:20
Conference pass
Panel Discussion: Digital Transformation – Innovator, disruptor or interrupter to the safety of patients?
Keynotes
Deepa Venkataraman, Vice President, Drug Safety and Pharmacovigilance, Corcept Therapeutics
Claudia Lehmann, Vice President, Head Global Patient Safety & Pharmacovigilance Operations, Boehringer Ingelheim International
Phil Tregunno, Deputy Director, Patient Safety Monitoring, Medicines & Healthcare products Regulatory Agency
Serban Ghiorghiu, Chief Safety Officer, AstraZeneca
Fabian Heisig, SVP, Head Global Drug Safety & Qualified Person for Pharmacovigilance, Grunenthal
Oct 411:30
Conference pass
Chair's Remarks
AI & Automation
Pav Rishiraj, Director, Head of Patient Safety & PV Expert Chair, Ipsen & ABPI
Oct 411:30
Conference pass
Chair's Remarks
Risk Management
Mette Stie Kallesøe, Head of Pharmacovigilance, QPPV, Hansa Biopharma
Oct 411:30
Conference pass
Chair's Remarks
Signal Detection & Management
Mattia Calissano, Head of Pharmacovigilance, Orchard Therapeutics
Oct 411:30
Conference pass
Chair's Remarks
Quality Assurance & Compliance
Valentina Mancini, Senior Director, Pharmacovigilance, QPPV, Shionogi & TransCelerate
Oct 411:30
Conference pass
Chair's Remarks
Case Processing
Franciane Flament, Senior Director, GPS Regional Oversight Team Head, Ipsen
Oct 411:30
Conference pass
Chair's Remarks
Medical Devices
Begum Benli Peker, Director, Head of Patient Safety Netherlands & Hub Lead, Bristol Myers Squibb
Oct 411:30
Conference pass
Oct 411:30
Conference pass
Chair's Remarks
Regulatory Affairs
Reinhold Schilling, Head of Global Pharmacovigilance, EU QPPV, Wörwag Pharma GmbH & Co. KG
Oct 411:30
Conference pass
Chair's Remarks
Vaccine Safety
Donia Al-Bastaky, Head of Drug Safety, Ministry of Health, Kuwait
Oct 411:30
Conference pass
Chair's Remarks
PV Outsourcing
Wally Landsberg, VP, Global Head Medical Safety, Kyowa Kirin, Inc.
Oct 411:35
Conference pass
Auditing special programs: a fine line between GCP and GVP
Quality Assurance & Compliance
Ranjana Khanna, Global Director, GVP, QA, Clinical and Medical Quality, BeiGene GmbH
Oct 411:35
Conference pass
Automation and pharmacovigilance: identifying risk factors for AEs
AI & Automation
Michael von Forstner, Global Head, Patient Safety and Pharmacovigilance Biosimilars, Biogen
Oct 411:35
Conference pass
CIOMS XII: Key principles for benefit risk assessments
Risk Management
Stewart Geary, Global Safety Officer, Eisai
Oct 411:35
Conference pass
Devices transforming pharmacovigilance
Medical Devices
James Whitehead, Senior Director, Devices and Digital Safety, Astra Zeneca
Oct 411:35
Conference pass
Implementation of competitive safety intelligence in an early post marketing context - a case study
Vaccine Safety
Lionel Van Holle, Founder, OpenSourcePV
Oct 411:35
Conference pass
Increasing productivity in ICSR management with automation
Case Processing
Hans-Jörg Römming, Executive Director, Head of GPS Operations, Merck
Oct 411:35
Conference pass
Interfaces between regulatory affairs and drug safety
Regulatory Affairs
Sarah Al-Musaed, Regulatory Affairs and Drug Safety Manager (LRP-PV), Grünenthal Denmark ApS
Oct 411:35
Conference pass
MHRA’s digital transformation journey
Digital Transformation
Sarah Vaughan, Head of Vigilance Development, MHRA
Oct 411:35
Conference pass
PV outsourcing in the MENA region
PV Outsourcing
Mina G Awad, Pharmacovigilance Manager and QPPV, Middle East., Kyowa Kirin International
Oct 411:35
Conference pass
Running DMCs from PV: pros and cons
Signal Detection & Management
Karsten Lollike, Corporate Vice President, QPPV, Novo Nordisk
Oct 411:55
Conference pass
Applying AI earlier in pharmacovigilance workflow to optimize patient centricity
AI & Automation
Oct 411:55
Conference pass
Enhancing patient safety: detecting signals to risk mitigation actions
Signal Detection & Management
Oct 411:55
Conference pass
Ensuring quality, when PV is outsourced
PV Outsourcing
Noelle Humphrey, Vice President of Quality, Primevigilance
Oct 411:55
Conference pass
Evolution of safety systems
Digital Transformation
Oct 411:55
Conference pass
MAH; EU and non-EU countries – how to keep oversight by using partners
Quality Assurance & Compliance
Lucy Green, QPPV Activity Manager, ProductLife Group
Minyar Chelly Kahloun, QPPV Director, ProductLife Group
Oct 412:15
Conference pass
AI & Real-World Evidence
AI & Automation
Stephanie Tcherny-Lessenot, Global Head of Benefit-Risk Evaluation, Sanofi
Oct 412:15
Conference pass
Building a product safety team
Medical Devices
Juan Daccach, Vice President, Global Product Safety, Merz Aesthetics
Oct 412:15
Conference pass
Case processing improvements with automation
Case Processing
Deanna Montes de Oca, Senior Director PV Operations -Case Management, Moderna Therapeutics
Oct 412:15
Conference pass
Company core safety information versus local labelling
Quality Assurance & Compliance
Delphine Bertram, Head of Safety Vigilance, EMEA, EU QPPV, Santen
Oct 412:15
Conference pass
Data science: upskilling the PV profession
Digital Transformation
Phillip Eichorn, Global Head of Drug Safety, Amryt
Oct 412:15
Conference pass
Impacts of MRNA vaccines on patient safety
Vaccine Safety
Wumi McDowall, Director, Pharmacovigilance, Medical & Regulatory QA, Seqirus
Oct 412:15
Conference pass
Managing PV compliance with small distribution partners
PV Outsourcing
Jutta Syha, Independent PV Expert
Oct 412:15
Conference pass
Preparing a regulatory safety response
Regulatory Affairs
Nicola Wallis, Executive Director, PV Innovation, UK QPPV, BeiGene Germany GmbH
Oct 412:15
Conference pass
RMP for biosimilars
Risk Management
Dimitris Zampatis, Global Program Safety Lead, Global Patient Safety, Sandoz
Oct 412:15
Conference pass
Validation of signals by means of a probabilistic causality assessment tool
Signal Detection & Management
Fabio De Gregorio, Vice President, Head Of Drug Safety Europe, Shionogi BV
Oct 412:35
Conference pass
Constantly evolving device regulations
Medical Devices
Vedaant Shourie, SME, PV Business & Systems Implementations, Pinnaxis
Oct 412:35
Conference pass
Different local PV operating models and their influence on QPPV oversight and PV System efficiency
PV Outsourcing
Ada Stelmakiene, Head of Pharmacovigilance, Insuvia
Oct 412:35
Conference pass
Leveraging LLMs & workflow automation for aggregate reporting
AI & Automation
Lalit Gehani, Practice Lead, Reporting & Analytics, Ultragenic
Oct 412:35
Conference pass
Navigating an automation strategy and making the leap to AI
Case Processing
Oct 412:35
Conference pass
Optimizing signal detection and management within a compliance framework
Signal Detection & Management
Philipp Hofmann, Director, Pharmacovigilance and Global QPPV, Navitas Life Sciences
Oct 412:35
Conference pass
Proactively plan your (d)RMP: When to start?
Risk Management
Hanneke Dominicus, Senior Manager, Benefit Risk, ProPharma Group Inc.
Oct 412:35
Conference pass
PV gap analysis - an assured tool for inspection readiness
Quality Assurance & Compliance
Jay Dave, Technical Director, Pharmacovigilance, COD research
Oct 412:55
Conference pass
AAV based gene therapies: case processing and signal detection challenges
Case Processing
Mason Shih, Vice President, Safety Science, BioMarin Pharmaceutical Inc.
Oct 412:55
Conference pass
Local and regional QPPV oversight integration into a global PV system
Quality Assurance & Compliance
Petra Lerner-Hiller, PV Quality and QPPV Relations Lead, Deputy QPPV, Merck
Oct 412:55
Conference pass
Natural language processing in pharmacovigilance and aggregate reports
AI & Automation
Israel Gutierrez, Chief Medical Officer, TLR Therapeutics
Oct 412:55
Conference pass
Regulatory intelligence in pharmacovigilance and future readiness
Regulatory Affairs
Ibrahim Altamawy, Medical Affairs & Compliance Regional Head (MENA), SAJA Pharmaceuticals
Oct 412:55
Conference pass
Regulatory strategies concerning drug delivery devices
Medical Devices
Ronald Boumans, EU Medical Devices Expert
Oct 412:55
Conference pass
Risk management of newly introduced oral contraceptives
Risk Management
Jorgen Matz, Head of Global Pharmacovigilance & Clinical Quality, EU QPPV, Insud Pharma
Oct 412:55
Conference pass
Signal detection during pandemic times: learning lessons
Vaccine Safety
Maria Maddalena Lino, Safety Risk Lead Director, COVID Vaccine, Pfizer
Oct 412:55
Conference pass
Staffing needs and structure of a PV department
Digital Transformation
Rudi Scheerlinck, Safety Strategy Lead, Merck Healthcare Oncology
Oct 412:55
Conference pass
The world of outsourcing: recent developments and insights
PV Outsourcing
Abiola David, Senior Director, Global Process Owner, ICSR Management, PV Operations, GSK
Oct 412:55
Conference pass
Ways to choose statistical methodologies for signal detection
Signal Detection & Management
Siva Kumar Buddha, Global Pharmacovigilance Physician, Senior Manager, Teva Pharmaceuticals
Oct 413:15
Conference pass
Diamond Sponsor Workshop: Best practices for case processing in pharmacovigilance
Keynotes
Location: G001
Venkat Venkataramanan, PV Domain Lead, Cognizant
Inder Sachdeva, Global Delivery Leader, Cognizant
G001
Oct 414:15
Conference pass
01 AI & Automation Panel - Processing innovations: increasing quality and efficiency using AI and automation
AI & Automation
Kapil Bhutada, Senior Director, Quality and Compliance, Inozyme Pharma
Fabrice Besle, Director, PV Database & Analytic Reporting, Ipsen
Marcin Kruk, Senior Director, Drug Safety Unit Regional Head, Europe, Africa & Middle East, Pfizer
Shaloo Pandhi, Senior Vice President, Global Head, Patient Safety, Sandoz
Amina Baljic, Head of PV Ops & PV Excellence, Grunenthal
Oct 414:15
Conference pass
02 Risk Management Panel - Evolutions in local risk minimization activities: effectiveness assessments using pharmacoepidemiology tools
Risk Management
John Solomon, Head of Pharmacovigilance, UK & Ireland, Sanofi
Suzanne Foncin, Senior Director, Head of Safety Analysis and Writing, UCB
Myriam Salem, Pharmacovigilance Manager, Health Canada
Anna Pelnivekich, Director, Head, Project Safety Reports, Merck
Mahalakshmi Elluri, Global Safety Director, Indivior Pharmaceuticals
Roger Mutter, Deputy QPPV, Galapagos GMBH
Oct 414:15
Conference pass
03 Signal Detection & Management Panel – Safety related posts to agency websites and submissions
Signal Detection & Management
Sean Burke, Senior Director, Regional Lead, International Pharmacovigilance, MSD
Amit Kubavat, Global Program Safety Lead, Sandoz International GmbH
Akhilesh Chamediya, Director, Senior Medical Expert Drug Safety, EU QPPV, AiCuris Anti-infective Cures AG
Ana Sofia Afonso, Director, Pharmacoepidemiology, Global Patient Safety, Eli Lilly
Mohammed Ali Kotal, Global Head, Medical Safety, Sandoz International GmbH
Thomas Organ, Safety Science Director, Neuroscience, Global Patient Safety, Ipsen
Oct 414:15
Conference pass
04 Quality Assurance & Compliance Panel – Inspections from an auditor’s perspective
Quality Assurance & Compliance
Raj Bhogal, Senior Director, R&D Business Strategy & Operations, Jazz Pharmaceuticals
Marianne Mounir, Senior Global Auditor, Bayer
Lucy Hampshire, Associate Vice President, Head, Medicines Quality Organisation International, Eli Lilly And Company
Mijal Chavda, Senior Director, Global Head of GxP Inspections & GVP Quality, Kyowa Kirin International
Tea Babic, Director, Head of PV Audits and Inspections, Deputy Head PV Compliance, Teva Pharmaceuticals
Oct 414:15
Conference pass
05 Case Processing Panel – Developing standards and approaches for quickly scaling company case processing
Case Processing
Majken Berghuis, Director, Pharmacovigilance, International Operations, Novo Nordisk
Paridhi Anand, Director, PV Operations, Standard and Training in Case Processing, Moderna Therapeutics
Linda Härmark, Deputy Director, Netherlands Pharmacovigilance Centre Lareb
Emma Boulton, Director, Safety Operations, Mundipharma
Inge Jeding-Jansen, Senior Director, Head of Global Pharmacovigilance, ALK
Oct 414:15
Conference pass
06 Medical Devices Panel - Different safety approaches between pharma, devices, and combination products
Medical Devices
Juan Daccach, Vice President, Global Product Safety, Merz Aesthetics
Lisa Benaise, Vice President, Head of PV, Calliditas
Judy Barretto, Global Process Owner, Signal Management Director, Roche
Oct 414:15
Conference pass
07 Digital Transformation Panel - Contrary to popular belief – digital transformation is about people first
Digital Transformation
Stella Lee, Asia-Pacific Drug Safety Unit, Coordinating Manager, Menarini Group
Sibel Guerler, Head of Innovation, Partnerships and Process Optimisation, WorldWide Patient Safety, Bristol Myers Squibb
Marianne Soergel, Drug Safety Lead, Molecular Partners AG
Ajibade Adesina, Director, PV Process Excellence and Learning Strategy, Bristol-Myers Squibb
Emma-Jane Brookes, Co-Founder, Partner, Truliant Consulting
Oct 414:15
Conference pass
08 Regulatory Affairs Panel – Labelling and patient safety in non-EU countries
Regulatory Affairs
Azira Cajic, Head of Division for Pharmacovigilance and Materiovigilance ALMBiH, Agency for Medicinal Product and Medical Devices BiH
Renato Rjavec, Product Director, ArisGlobal LLC
Marjan Dzeparoski, RA and PV Manager, Bionika Pharmaceuticals
Branka Stojanovic, Country Safety Lead, Serbia, QPPV, Pfizer
Sandra Reda, Quality Assurance Specialist & Deputy QPPV, New Bridge Pharmaceuticals F.Z. .L.L.C
Donia Al-Bastaky, Head of Drug Safety, Ministry of Health, Kuwait
Oct 414:15
Conference pass
09 Interactive Panel - Using real-world data across the pharmacovigilance lifecycle
Vaccine Safety
Jeff Brown, Chief Scientific Officer, TriNetX
Nathan Rivers, Senior Manager, Medical Safety, Jazz Pharmaceuticals
Oct 414:15
Conference pass
10 PV Outsourcing Panel – Evolution of outsourcing
PV Outsourcing
Lynne Comiskey, PV Regions Hub Coordination Lead, Sanofi
Kieran O'Donnell, Independent PV Expert
Jin Vermaat, Vice President and Head of PV Affiliate Relations, Takeda
Monika Zych, Director, Pharmacovigilance ECEMEA, Baxter
Claudia Maria Pammer, Head of Pharmacovigilance, Lyomark Pharma GmbH, Bendalis GmbH
Caitlin Keel, Director, Global Head of Case Management & Standards, Global Product Safety and Pharmacovigilance, United Therapeutics
Oct 415:10
Conference pass
Chair's Remarks
AI & Automation
Hans-Jörg Römming, Executive Director, Head of GPS Operations, Merck
Oct 415:10
Conference pass
Chair's Remarks
Signal Detection & Management
Marcin Marciniak, Senior Director, Global Safety and PV Expert WHC, Gedeon Richter Switzerland
Oct 415:10
Conference pass
Chair's Remarks
Quality Assurance & Compliance
Lucy Hampshire, Associate Vice President, Head, Medicines Quality Organisation International, Eli Lilly And Company
Oct 415:10
Conference pass
Chair's Remarks
Case Processing
Smruti Kothari, Associate Director, PV QA, Jazz Pharmaceuticals
Oct 415:10
Conference pass
Chair's Remarks
Medical Devices
Milos Stojkovic, Safety Process Director, ROCHE
Oct 415:10
Conference pass
Chair's Remarks
Digital Transformation
Ajibade Adesina, Director, PV Process Excellence and Learning Strategy, Bristol-Myers Squibb
Oct 415:10
Conference pass
Chair's Remarks
Regulatory Affairs
Attila Olah, Head Global Patient Safety, EU/UK-QPPV, Gedeon Richter PLC
Oct 415:10
Conference pass
Chair's Remarks
Vaccine Safety
Saikat Biswas, Global Head of Medical devices & Pharmaceutical services, Wipro
Oct 415:10
Conference pass
Chair's Remarks
PV Outsourcing
Gemma Jimenez Sese, Patient Safety Director, Almirall
Oct 415:10
Conference pass
Oct 415:15
Conference pass
Challenges in interactions between pharmacovigilance and regulatory departments
Regulatory Affairs
Marco Colombati, PV Operations Manager, ITALFARMACO S.P.A.
Oct 415:15
Conference pass
Fractional stratified k-fold cross validation: A new methodology to investigate training data sufficiency in computer system validation
AI & Automation
Juergen Dietrich, Senior Lead Data Scientist, Pharmacovigilance, Bayer AG
Oct 415:15
Conference pass
Generic risk minimization doesn’t mean low quality but high service
Risk Management
Michael von Forstner, Global Head, Patient Safety and Pharmacovigilance Biosimilars, Biogen
Oct 415:15
Conference pass
Inspections: the good, the bad & the things nobody tells you!
Quality Assurance & Compliance
Mijal Chavda, Senior Director, Global Head of GxP Inspections & GVP Quality, Kyowa Kirin International
Oct 415:15
Conference pass
Journey to compliance: local PV set up with service providers
PV Outsourcing
Nicola Wallis, Executive Director, PV Innovation, UK QPPV, BeiGene Germany GmbH
Oct 415:15
Conference pass
Merging companies ICSR processes in parallel with changing safety databases
Case Processing
Anna Liptak Askne, Director, ICSR Post-marketing, AstraZeneca
Anna Karin Traff, Director, ICSR Lead, AstraZeneca
Oct 415:15
Conference pass
Misuse or off-label use of medical devices
Medical Devices
Daniela Gramaglia, Medical Device Vigilance Manager, Chiesi Farmaceutici SpA
Oct 415:15
Conference pass
Repurposing old vaccines for current and future pandemics
Vaccine Safety
Nibedita Rath, Scientific Director, Open Source Pharma Foundation
Oct 415:15
Conference pass
Signal evaluation and management: future innovations
Signal Detection & Management
Carolyn Cranfield, Director, Global Process Owner, PV Excellence, Global Safety, GSK
Oct 415:15
Conference pass
Simplifying with automation today: implementing innovation
Digital Transformation
Mark Widdowson, Manager, Digital Insights and Innovation, Bristol Myers Squibb
Oct 415:35
Conference pass
Cutting-edge insights into vaccine safety in preterm infants: a 2023 update
Vaccine Safety
Camille Lenoir, Safety Scientist, UBC
Antoinette Defaux, Associate Director, Pharmacovigilance, UBC
Oct 415:35
Conference pass
Effective execution of an early access program
PV Outsourcing
Hayley Marsh, Senior Vigilance Scientist, Voisin Consulting Life Sciences
Oct 415:35
Conference pass
Generative AI: path to implementation in PV case processing and beyond
Case Processing
Nikesh Shah, Vice President, Global Head, Drug Safety & PV, Indegene
Oct 415:35
Conference pass
Managing safety reporting complexity through intelligence automation
Quality Assurance & Compliance
Oct 415:35
Conference pass
Navigating the digital fog: a case for intelligent automation in drug safety
Digital Transformation
Sanjeev Srivastav, Director, PV Signal, RxLogix
Oct 415:35
Conference pass
Proactive, hypothesis free signal detection
Signal Detection & Management
Elizabeth Smalley, Director, Product Management Data and Analytics, ArisGlobal LLC
Oct 415:35
Conference pass
PV & safety automation to centralizing local market support: language & literature
AI & Automation
Christine Buggle, Senior Director, TransPerfect
Oct 415:35
Conference pass
The Sobi experience with controlled distribution using electronic systems
Risk Management
Maria Dahlin, Director, Global Pharmacovigilance & Patient Safety, Sobi (Swedish Orphan Biovitrum)
Oct 415:55
Conference pass
AI and implications of upskilling: consequences and challenges
AI & Automation
Uwe Gudat, Chief Medical Officer, Aretaeus sàrl
Oct 415:55
Conference pass
Digital transformation in case processing within Moderna
Case Processing
Monika Kowalska, Director, PV Operations ICSR Quality, Moderna
Oct 415:55
Conference pass
From health authority requirements to aggregate reports: ensuring vaccine safety compliance
Vaccine Safety
Antonella Fretta, Senior Director, Aggregate Reporting Team Lead, Pfizer
Oct 415:55
Conference pass
Global regulatory trends: a futuristic view
Regulatory Affairs
Samah Ragab, Director, Regulatory Affairs & PV, Middle East, Organon
Oct 415:55
Conference pass
Harvesting safety data for scientific decisions
Digital Transformation
Sameen Desai, Executive Director, Head of Worldwide Patient Safety and Risk Management IT, Bristol-Myers Squibb
Oct 415:55
Conference pass
Looking to the future; beyond education to behavioural support and proactive risk management
Risk Management
Mark Perrott, Founder, Managing Partner, Axian Consulting Ltd.
Oct 415:55
Conference pass
Mapping surveillance across departments: combination products
Medical Devices
Janni Hermansen, Head, Global Safety Surveillance, Biologics & Devices, LEO Pharma
Oct 415:55
Conference pass
Outsourcing decisions, strategies and operating models for clinical safety
PV Outsourcing
Conny Johansson, Alliance Management Lead, Roche
Oct 415:55
Conference pass
Pharmacovigilance intelligence in a global PV system
Quality Assurance & Compliance
Tsambika Fuchs, Team Lead PV Intelligence and Performance Management, Merck Healthcare KGaA
Oct 415:55
Conference pass
Preparing for the future: signals and surveillance for psychedelic and opioid drugs
Signal Detection & Management
Richard Dart, Executive Director, Rocky Mountain Poison & Drug Center
Oct 416:45
Conference pass
Chair's Remarks
AI & Automation
Amira Modi, Global Head, SRQ GTM Strategy, Marketing and Enablement, IQVIA
Oct 416:45
Conference pass
Chair's Remarks
Risk Management
Jan Cleerbout, Deputy EU QPPV, QPPV Office, Johnson & Johnson
Oct 416:45
Conference pass
Chair's Remarks
Signal Detection & Management
Linda Bech, Associate Director, Head of Patient Safety Nordics, Gilead Sciences
Oct 416:45
Conference pass
Chair's Remarks
Quality Assurance & Compliance
Santiago Schiaffino, Medical Director, Senior Patient Safety Physician, AstraZeneca
Oct 416:45
Conference pass
Chair's Remarks
Case Processing
Meenakshi Ramachandran, Manager, Drug Safety, Molecular Partners AG
Oct 416:45
Conference pass
Chair's Remarks
Digital Transformation
Ariane Stollenwerk, Head of Central Europe & Asian Int. Markets, International PhV,, UCB Pharma
Oct 416:45
Conference pass
Chair's Remarks
Patient Centricity
Olga Panek-Białkowska, Associate Director, Global Pharmacovigilance Case Management, MSD Polska
Oct 416:45
Conference pass
Chair's Remarks
Vaccine Safety
Veronica Urdaneta, Senior Director, Global Safety Physician, Moderna
Oct 416:45
Conference pass
Chair's Remarks
PV Outsourcing
Laura Paola Boga, Head of Global Pharmacovigilance, UK & EU QPPV, Dompé farmaceutici SpA
Oct 416:50
Conference pass
Adverse events in the digital age
AI & Automation
Robert Di Giovanni, Global Patient Safety Lead, Novartis
Oct 416:50
Conference pass
Competency acceleration: enabling leaders in role, putting patients at the centre
Patient Centricity
Darren Stewart, Chief Experience Officer, Competency Accelerator, F. Hoffmann-La Roche
Oct 416:50
Conference pass
From regulatory intelligence to effective implementation of PV regulatory requirements
Quality Assurance & Compliance
Maud Le Petitcorps, Associate Director Safety Oversight, Johnson & Johnson
Oct 416:50
Conference pass
Importance of quality in case processing
Case Processing
Kavita Ramji, Safety Officer, Pfizer
Oct 416:50
Conference pass
Personal data protection and pharmacovigilance: points to consider
Digital Transformation
Sergiy Kryvych, Senior Drug Safety Officer & Medical Advisor, Deputy Local Pharmacovigilance Responsible Person, Pfizer
Oct 416:50
Conference pass
Quantitative signal detection: a targeted approach
Signal Detection & Management
Tommaso Venturi, Corporate Risk Assessment Specialist, ITALFARMACO S.P.A.
Oct 416:50
Conference pass
Safety risk management strategies: process and oversight
Risk Management
Melanie Demarke, Director, Global Process Owner, PV Excellence, Global Safety, GSK
Oct 416:50
Conference pass
Successfully outsourcing local safety activities
PV Outsourcing
Wivina De Waele, Senior Director, Safety Lead Europe, Global Patient Safety, Alexion – AstraZeneca Rare Disease
Oct 416:50
Conference pass
Vaccine pharmacovigilance in outbreak situations
Vaccine Safety
Heinz Weidenthaler, Vaccine Pharmacovigilance Expert
Oct 417:10
Conference pass
Post-COVID safety signal detection from spontaneous reporting systems
Signal Detection & Management
Jordi Mestres, CSO & Founder, Chemotargets
Oct 417:10
Conference pass
Transform your drug safety processes with natural language processing
AI & Automation
Oct 417:10
Conference pass
What to check in qualifying a vendor for efficient pharmacovigilance outsourcing.
PV Outsourcing
Galina Stamenova, Senior Safety Manager, Excelya
Oct 417:30
Conference pass
Expectations for QPPV oversight
Quality Assurance & Compliance
Margherita D'Antuono, EU-UK QPPV, Piramal Critical Care
Oct 417:30
Conference pass
Global safety assessment for the Moderna mRNA COVID-19 vaccine: analysis after 1.3 billion doses
Vaccine Safety
Veronica Urdaneta, Senior Director, Global Safety Physician, Moderna
Oct 417:30
Conference pass
Integrating data across regions: analyzing regulatory complexities for AI & automation
AI & Automation
Teresa Saragoça, Director, Regulatory Affairs & Technical Manager, Italfarmaco
Oct 417:30
Conference pass
Learning lessons on implementation of pregnancy prevention program at a generic set up
Risk Management
Dnyaneshwar Sanap, EU & UK QPPV, Head, Regional PV and Global Compliance Training, Glenmark Pharmaceuticals
Oct 417:30
Conference pass
Outsourcing effects on QPPVs
PV Outsourcing
Bert Van Leeuwen, Deputy QPPV, Astellas Pharma Europe BV
Oct 417:30
Conference pass
Patient safety & customer engagement pro-grams: potential challenges, solutions and the importance of cross functional teams
Patient Centricity
Amar Swaroop, Director, Global Lead, Customer Engagement Programmes, Viatris
Oct 417:30
Conference pass
Professional development in PV: attracting and developing talent through internal training programs
Digital Transformation
Karolina Danysz, Associate Director, PV Affiliate Relations Liason, EUCAN, Takeda
Oct 417:30
Conference pass
Signal detection: clinical development vs post marketing: do you have the right profile for the job?
Signal Detection & Management
Kishore Saha, Chief Specialist, Lundbeck
Create your personal agenda –check the favourite icon
Oct 58:55
Conference pass
Chair’s remarks
Keynotes
Francoise Sillan, Vice President, Global Patient Safety, EU & UK QPPV, Ipsen
Oct 59:00
Conference pass
The new post-COVID pharmacovigilance landscape
Keynotes
Patrick Caubel, Chief Safety Officer, Pfizer
Oct 59:20
Conference pass
Rethinking safety services - a tech / AI driven future of PV
Keynotes
Sanjay Vyas, Executive Vice President, Safety & Logistics and Country Head of India, Parexel
Oct 59:40
Conference pass
Moving drug safety departments from cost centres to strategic partners
Keynotes
Fatima Bhayat, Vice President, Head of Global Patient Safety and Chief Safety Officer, Amgen Inc
Oct 510:00
Conference pass
Globalizing pharmacovigilance systems to navigate dynamic regulatory landscape with speed and efficiency
Keynotes
Oct 510:20
Conference pass
Managing pharmacovigilance in Asia-Pacific: challenges and opportunities
Keynotes
Gloria Bustos, Senior Director, Head of Pharmacovigilance, EMEA & APAC / Global Patient Safety, Baxter Healthcare
Oct 511:30
Conference pass
Chair's Remarks
AI & Automation
Claudia Lehmann, Vice President, Head Global Patient Safety & Pharmacovigilance Operations, Boehringer Ingelheim International
Oct 511:30
Conference pass
Chair's Remarks
Risk Management
Balwant Heer, Vice President, Global Head of Drug Safety, Viatris
Oct 511:30
Conference pass
Chair's Remarks
Signal Detection & Management
Howard Snow, Vice President, Head of Pharmacovigilance, Sobi (Swedish Orphan Biovitrum)
Oct 511:30
Conference pass
Chair's Remarks
Quality Assurance & Compliance
Jeremie Dedessus Le Moutier, Head of Global PV Excellence, Global Safety, GSK
Oct 511:30
Conference pass
Chair's Remarks
Case Processing
Ellen Ravn Englev, Senior Director, SO Processes & PV Technology, Safety Operations, Global Safety, Novo Nordisk
Oct 511:30
Conference pass
Chair's Remarks
Medical Devices
Begum Benli Peker, Director, Head of Patient Safety Netherlands & Hub Lead, Bristol Myers Squibb
Oct 511:30
Conference pass
Chair's Remarks
Digital Transformation
Pilar Carrero, Vice President, Global Safety, LEO Pharma
Oct 511:30
Conference pass
Chair's Remarks
Patient Centricity
Linda Härmark, Deputy Director, Netherlands Pharmacovigilance Centre Lareb
Oct 511:30
Conference pass
Chair's Remarks
Safety in the US
David Lilienfeld, Vice President, Drug Safety and Pharmacovigilance, Elevar Therapeutics
Oct 511:30
Conference pass
Chair's Remarks
Translational Safety
Marcin Kruk, Senior Director, Drug Safety Unit Regional Head, Europe, Africa & Middle East, Pfizer
Oct 511:35
Conference pass
Achieving scalability in case processing capabilities through digitization
Case Processing
Katarzyna Gruchala, Director, PV Operations Case Processing, Moderna
Oct 511:35
Conference pass
Challenges of signal detection in orphan medicinal products
Signal Detection & Management
Erika Barbarosie, Associate Director, Compliance, Gilead Sciences
Oct 511:35
Conference pass
Connecting patient level to molecular data: an ongoing review
Translational Safety
Sibel Guerler, Head of Innovation, Partnerships and Process Optimisation, WorldWide Patient Safety, Bristol Myers Squibb
Oct 511:35
Conference pass
Impact of pharmacogenomic information on labelling
Risk Management
Giovanni Furlan, Worldwide Safety Site Lead & Safety Risk Lead Director, Pfizer
Oct 511:35
Conference pass
Physical devices: current challenges and considerations for combination products
Medical Devices
Judy Barretto, Global Process Owner, Signal Management Director, Roche
Oct 511:35
Conference pass
Publishing PV data: What to expect and how to manage
Safety in the US
James Eldridge, Director, Pharmacovigilance North America, Y-mAbs
Oct 511:35
Conference pass
QPPV gatekeeper operating model: driving efficient QPPV oversight
Digital Transformation
Jessica Mårlind Würtele, Director, Patient Safety Excellence, AstraZeneca
Oct 511:35
Conference pass
Quality management planning for pharmacovigilance
Quality Assurance & Compliance
Marlo Corrao, Quality Director, Pharmacovigilance Excellence, GSK
Oct 511:35
Conference pass
Updates in patient centricity and pharmacovigilance
Patient Centricity
Stephanie Tcherny-Lessenot, Global Head of Benefit-Risk Evaluation, Sanofi
Oct 511:35
Conference pass
Use of AI in ICSRs: regulatory experiences of AI in PV
AI & Automation
Sarah Vaughan, Head of Vigilance Development, MHRA
Oct 511:55
Conference pass
Managing PV for emerging regulators
Case Processing
Inder Sachdeva, Global Delivery Leader, Cognizant
Venkat Venkataramanan, PV Domain Lead, Cognizant
Oct 511:55
Conference pass
Transforming literature management using smart digital automation
Digital Transformation
Saikat Biswas, Global Head of Medical devices & Pharmaceutical services, Wipro
Oct 512:15
Conference pass
Applications of machine learning in safety surveillance & risk management
AI & Automation
Philip Jones, Senior Director, Disease Area Cluster Lead, Inflammation & Immunology, Pfizer
Oct 512:15
Conference pass
Applying consumer centric approaches in risk management
Patient Centricity
Dagmara Okla, Senior Director, Head of Global Safety, Clinical Development & Medical Affairs Quality, Excellence & Governance, EU QPPV, Haleon
Oct 512:15
Conference pass
Experience with structured benefit-risk assessment
Risk Management
Suzanne Foncin, Senior Director, Head of Safety Analysis and Writing, UCB
Oct 512:15
Conference pass
Increasing collaboration and compliance in the area of investigator sponsored studies (ISS)
Case Processing
Jill Leake, Director, Head of Clinical Safety Operations, Merck Healthcare KGaA
Oct 512:15
Conference pass
Pregnancy and breast feeding regulatory land-scape assessment: outcomes and proposed solutions
Safety in the US
Nadezda Abramova, Safety Strategy Lead, Merck Healthcare KGaA
Leesha Balramsingh-Harry, Safety Data Acquisition Lead, Roche
Oct 512:15
Conference pass
PSMFs on a global or local level
Quality Assurance & Compliance
Hadir Rostom, President, ISoP Egypt Chapter
Oct 512:15
Conference pass
Safety considerations for inhaled drug delivery systems
Medical Devices
Santanu Mukhopadhyay, Head, Medical Safety, VecturaFertin Pharma
Oct 512:15
Conference pass
The future of PV: impact of digital and social trans-formation
Digital Transformation
Ricarda Tiemeyer, Head of Pharmacovigilance, DACH Region, Biogen
Oct 512:15
Conference pass
Translational psychiatry: genome guided treatments of psychiatric patients
Translational Safety
George Patrinos, Professor, Department of Pharmacy & Adjunct Professor, Department of Genetics and Genomics, University of Patras & United Arab Emirates University
Oct 512:15
Conference pass
Underlying diseases and signal detection: challenges with limited patient populations
Signal Detection & Management
Steve Dingman, Vice President, Head of Pharmacovigilance, ImmunoGen Inc
Oct 512:35
Conference pass
Artful simplification: transforming pharmacovigilance
AI & Automation
Vivek Ahuja, Senior Vice President, Global Delivery Excellence, Strategy & Growth, PV, Quality & Regulatory Service Lines, Eversana
Oct 512:35
Conference pass
Benefit-risk 360: enabling real-time safety surveillance oversight and proactive benefit-risk management
Risk Management
Kevin Fetterman, Exec Director, Client Engagement, Orbit By Feith Systems
Oct 512:35
Conference pass
Evaluation of drug-induced liver injury risk in pre marketing clinical drug trials
Signal Detection & Management
Sumit Verma, President, Clinical Safety and PV, Soterius, Inc.
Oct 512:35
Conference pass
Nurturing a culture of quality within drug safety
Case Processing
Humaira Qureshi, President, Qinecsa Solutions
Oct 512:55
Conference pass
Automation: the good, the bad and the ugly
AI & Automation
Marina Suvakov, Global Head Product, Safety Surveillance, Philip Morris International
Oct 512:55
Conference pass
Bringing in outsourced activities
Digital Transformation
Irina Maria Ciubotaru, Head of Pharmacovigilance and Drug Safety, ITM Isotope Technologies Munich SE
Oct 512:55
Conference pass
Identifying and managing signals in oncology populations: balancing benefit-risk
Signal Detection & Management
Simon Ashworth, Head of Pharmacovigilance and Medical Safety, Ono Pharmaceutical Co., Ltd
Oct 512:55
Conference pass
Potential drug safety risks associated with drug development
Translational Safety
Galina Cordero, Head of Pharmacovigilance Department, QPPV, JSC Farmak
Oct 512:55
Conference pass
Proportional centralized approach to pharmacovigilance in consumer healthcare
Patient Centricity
John Poustie, EMEA Pharmacovigilance Director, UK QPPV, Haleon
Oct 512:55
Conference pass
Risk assessments for audits
Quality Assurance & Compliance
Gemma Berry Jones, Associate Director, GVP Quality, Kyowa Kirin
Oct 512:55
Conference pass
Risk management approaches: comparisons between the EU and US
Safety in the US
Markus Drumm, Head of Global Patient Safety Regions, Merck Healthcare KGaA
Oct 512:55
Conference pass
Risk management planning in clinical development
Risk Management
Mircea Ciuca, Independent PV Expert
Oct 512:55
Conference pass
Substance based medical devices
Medical Devices
Joan D’souza, Independent PV Expert
Oct 512:55
Conference pass
Transferring to a new safety database: academic clinical trials
Case Processing
Tuula Ikonen, Head of Pharmacovigilance, E.O.R.T.C.
Oct 514:15
Conference pass
02 Risk Management Panel - Benefit risk management and assessments: challenges and opportunities
Risk Management
Anja-Helena Loos, Director, Biostatistics Oncology, Merck
Robert Massouh, Head, Risk Management and Benefit-Risk Evaluation, GSK
Elian Khazneh, Head of GPS, Benefit Risk Strategy and Management, Global Patient Safety, Merck Healthcare KGaA
Balaji Sainath Malla, Head of Pharmacovigilance, QPPV- EU & UK, Dr. Reddy's Laboratories Inc
Luiz Lima, Vice President, Global Patient Safety, Therapeutic Area Lead, Neuroscience, Ipsen
Oct 514:15
Conference pass
03 Signal Detection & Management Panel – Equitable access to pharmacovigilance services
Signal Detection & Management
Francoise Sillan, Vice President, Global Patient Safety, EU & UK QPPV, Ipsen
Olga Menang, Director, Drug Safety and Pharmacovigilance, Fresenius Kabi
Nkululeko Mdladla, Clinical Safety Manager, ViiV Healthcare
Leith Kwaan, QPPV, National Bioproducts Institute NPC
Natalie Farrar, Director, Safety and Pharmacovigilance, ViiV Healthcare
Alexandru Barbarosie, EU/UK QPPV, Global Safety Lead, Amryt Pharma
Oct 514:15
Conference pass
04 Quality Assurance & Compliance Panel – Modular approaches to PSMFs
Quality Assurance & Compliance
Franziska Rathjens, Head of Business Process Management & PV Tools, Deputy QPPV, B Braun
Monika Manske, Lead Quality Management and Deputy EEA QPPV, Viatris
Clara Goncalves, Head QPPV And Alliance Office, Grunenthal
Emma Wiman, Director, Regulatory Compliance & Quality, EMENA, accord healthcare
Oct 514:15
Conference pass
06 Medical Devices Panel – The role of persons responsible for regulatory compliance in postmarketing surveillance for medical devices
Medical Devices
James Whitehead, Senior Director, Devices and Digital Safety, Astra Zeneca
Milos Stojkovic, Safety Process Director, ROCHE
Stella Lee, Asia-Pacific Drug Safety Unit, Coordinating Manager, Menarini Group
Janni Hermansen, Head, Global Safety Surveillance, Biologics & Devices, LEO Pharma
Oct 514:15
Conference pass
07 Digital Transformation Panel - QPPV oversight and digital transformation
Digital Transformation
Ilaria Grisoni, Executive Director, Head of EU & International Pharmacovigilance, QPPV Office and EEA QPPV, Jazz Pharmaceuticals
Maria Jose Reneses, Director, Deputy EU QPPV and Head of PSMF, Takeda
Veronica Fjellstrom, Head, Global Patient Safety & Medical Information, EU & UK QPPV, Karo Pharma
Klaus Bitsch-Jensen, Director, Head of QPPV Office, EU QPPV, ALK
Raphael Van Eemeren, Senior Director, EU/UK QPPV, Global Patient Safety,, Amgen
Oct 514:15
Conference pass
08 Patient Centricity Panel – Real world evidence in patient support programmes
Patient Centricity
Mary Lynne Van Poelgeest-Pomfret, President, World Federation For Incontinent Patients
Linda Härmark, Deputy Director, Netherlands Pharmacovigilance Centre Lareb
Garry Flounders, Global Pharmacovigilance Operations Lead, Biosimilars, Biogen
Will Pajak, Senior Business Process Leader, International Patient Safety, Roche
Alina Tudor, Senior Director, Pharmacovigilance, Kyowa Kirin
Oct 514:15
Conference pass
09 Quality Assurance & Compliance Panel – Challenges and best practices for PV legislation implementation
Safety in the US
Anne Raison, Head of Quality and Medical Compliance Management, ROCHE
Emmanuelle Pinès, Head of Safety Policy & Process Oversight, QPPV Office, Janssen
Sophie Radicke, Head of GPvP and Senior Pharmacovigilance Inspector, MHRA
Diane Halle, Senior Manager, Pharmacovigilance Quality Assurance, Alnylam Pharmaceuticals
Oct 514:15
Conference pass
10 Translational Safety Panel - Pharmacovigilance in cell and gene therapies
Translational Safety
David Chonzi, Global Head of PVE, Instil Bio
Oct 515:10
Conference pass
Chair's Remarks
AI & Automation
Aman Wasan, Chief Commercial Officer, ArisGlobal LLC
Oct 515:10
Conference pass
Chair's Remarks
Risk Management
Eva Van Engelen, Director, Global Patient Safety, Gilead Sciences
Oct 515:10
Conference pass
Chair's Remarks
Signal Detection & Management
Ellen Bonagua, Executive Director, Drug Safety, Insmed Incorporated
Oct 515:10
Conference pass
Chair's Remarks
Quality Assurance & Compliance
Wasim Anwar, Vice President & Deputy QPPV, Novo Nordisk A/S
Oct 515:10
Conference pass
Chair's Remarks
Case Processing
Daniela Di Cosmo, Senior Safety Advisor, Global Safety, Ferring Pharmaceuticals
Oct 515:10
Conference pass
Chair's Remarks
Digital Transformation
Peter De Veene, QPPV, Incyte Biosciences
Oct 515:10
Conference pass
Chair's Remarks
Patient Centricity
Devi Padmanaban, Executive Director, Drug Safety, Neurocrine Biosciences
Oct 515:10
Conference pass
Chair's Remarks
Translational Safety
Henk Johan Streefkerk, CEO & Medical Director, Amarna Therapeutics Bv
Oct 515:15
Conference pass
Evolution of quantitative and qualitative case management data
Case Processing
Caitlin Keel, Director, Global Head of Case Management & Standards, Global Product Safety and Pharmacovigilance, United Therapeutics
Oct 515:15
Conference pass
How artificial intelligence and automation can change drug safety management
AI & Automation
Marco Tuccori, Pharmacovigilance Manager, Coordinator & Co-Chair, University Hospital of Pisa, Tuscan Regional Centre of Pharmacovigilance & ISoP Scientific Board
Oct 515:15
Conference pass
Overview of REMS program development
Safety in the US
Lilliam Fernandes, Director, Clincial Safety and Pharmacovigilance, Adaptimmune LLC
Oct 515:15
Conference pass
PSMF: Common challenges and inspection readiness
Quality Assurance & Compliance
Isabella Caramuta, Deputy QPPV, Shionogi BV
Oct 515:15
Conference pass
PV and pharmaceutical manufacturing
Risk Management
Rainer Heissing, Executive Director, Deputy EU/UK QPPV, Gilead Sciences
Oct 515:15
Conference pass
Reimagining signal detection in LMICs
Signal Detection & Management
Nkululeko Mdladla, Clinical Safety Manager, ViiV Healthcare
Oct 515:15
Conference pass
Safety real world evidence for treatment decisions
Patient Centricity
Jost Leemhuis, Safety Science Partner, ROCHE
Oct 515:15
Conference pass
Translating preclinical safety findings into the design of the first in human study
Translational Safety
Henk Johan Streefkerk, CEO & Medical Director, Amarna Therapeutics Bv
Oct 515:15
Conference pass
Use of a database for the management of pharmacovigilance agreements
Digital Transformation
Marko Strott, Associate Director, Partnership Management, Global Patient Safety, Merck
Oct 515:55
Conference pass
Accommodating local and regional reporting requirements in a global PV organization
Case Processing
Bartosz Olas, Principal Safety Data Manager, Global Pharmacovigilance Case Management, MSD Polska
Oct 515:55
Conference pass
Applications of AI & machine learning in pharmacovigilance: from automation to copilot
AI & Automation
Philip Jones, Senior Director, Disease Area Cluster Lead, Inflammation & Immunology, Pfizer
Oct 515:55
Conference pass
Applying health literacy principles: advances and innovations
Translational Safety
Kate Anteyi, Director, Global Safety Physician, Moderna Therapeutics
Oct 515:55
Conference pass
Future directions in signal detection, evaluation and communication
Signal Detection & Management
Vipin Sethi, Head Of Global Pharmacovigilance And Medical Affairs, Cadila Pharmaceuticals
Oct 515:55
Conference pass
Myocarditis and pericarditis after mRNA-vaccines: addressing additional risk management strategies
Risk Management
Veronica Urdaneta, Senior Director, Global Safety Physician, Moderna
Oct 515:55
Conference pass
PV hubs powering affiliate transformation towards greater patient centricity
Patient Centricity
Michael Becker, International PV, Global Head, PV Hubs, ROCHE
Oct 515:55
Conference pass
PV quality management in biotechs
Quality Assurance & Compliance
Gemma Sayers, Director, Pharmacovigilance Quality Management Lead, Regeneron Pharmaceuticals
Oct 515:55
Conference pass
Transforming pharmacovigilance: elevating skills through a digital platform and innovative skills framework
Digital Transformation
Ajibade Adesina, Director, PV Process Excellence and Learning Strategy, Bristol-Myers Squibb
Oct 516:45
Conference pass
Chair's Remarks
Risk Management
Natasa Mihajlovic, Managing Director, NostraPharma Ltd
Oct 516:45
Conference pass
Chair's Remarks
Signal Detection & Management
Karin Thelen, Head of Drug Safety, Cardior Pharmaceuticals
Oct 516:45
Conference pass
Chair's Remarks
Quality Assurance & Compliance
Jolanda De Bruijne, Senior Director, Head of PV Compliance, Teva Pharmaceuticals
Oct 516:45
Conference pass
Chair's Remarks
Patient Centricity
Gabrielle Amselem, Director, Patient Safety Excellence, AstraZeneca & Alexion
Oct 516:50
Conference pass
Failures of risk minimization measures: common findings when things go wrong
Risk Management
Natasa Mihajlovic, Managing Director, NostraPharma Ltd
Oct 516:50
Conference pass
First experience with IRIS platform for EMA GVP inspection
Quality Assurance & Compliance
Julia Appelskog, EU QPPV, Global Vaccine Safety, Novavax
Oct 516:50
Conference pass
Peculiarities of signal detection in paediatric population
Signal Detection & Management
Sutirtha Mukhopadhyay, Senior Patient Safety Physician, Boehringer Ingelheim
Oct 516:50
Conference pass
Speaker presentation
Translational Safety
Galina Cordero, Head of Pharmacovigilance Department, QPPV, JSC Farmak
Oct 516:50
Conference pass
Substance based medical devices
Medical Devices
Joan D’souza, Independent PV Expert
Oct 517:30
Conference pass
First experience with IRIS platform for EMA GVP inspection
Quality Assurance & Compliance
Julia Appelskog, EU QPPV, Global Vaccine Safety, Novavax
last published: 21/Sep/23 15:55 GMT
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