2024 AGENDA
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Amsterdam, 9 - 10 October 2024
Schedule
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Oct 98:00
Conference pass
Registration & Networking Meetings
Keynotes
Registration & Networking Meetings
Oct 98:55
Conference pass
Oct 99:00
Conference pass
Clinical Safety: evolving Patient Safety to achieve global drug development and health equity ambitions
Keynotes
Serban Ghiorghiu, Chief Safety Officer, AstraZeneca
Oct 99:20
Conference pass
Disruption in safety systems: cutting through GenAI hype to generate true ROI
Keynotes
Aman Wasan, Chief Executive Officer, ArisGlobal LLC
Oct 99:40
Conference pass
Enhancing medicines safety through external databases and artificial intelligence
Keynotes
Felix Arellano, Global Head of Pharmacovigilance and Drug Safety, Roche
Oct 910:00
Conference pass
Navigating the current & future: practical implications of GenAI in pharmacovigilance
Keynotes
Session Reserved for Parexel
Sanjay Vyas, President, Safety & Logistics and Country Head, India, Parexel
Oct 910:20
Conference pass
Regulatory and Drug Safety: Two key partners in a formidable journey
Keynotes
Oct 910:40
Conference pass
The future of pharmacovigilance: trends for 2025 and beyond
Keynotes
Session Reserved for IQVIA
Updesh Dosanjh, Practice Lead Safety Technology, IQVIA
Oct 911:00
Conference pass
Morning Break
Keynotes
Morning Break
Oct 911:40
Conference pass
Chair's Remarks
AI & Automation, Auditorium
Moderation
Pav Rishiraj, Director, Head of Patient Safety & ABPI PV Expert Chair, Ipsen & ABPI
Oct 911:40
Conference pass
Chair's Remarks
Risk Management, Exhibition Hall
Chair's Remarks - AXIAN
Oct 911:40
Conference pass
Chair's Remarks
Signal Detection & Management, Exhibition Hall
Oct 911:40
Conference pass
Chair's Remarks
Quality Assurance, G102
Oct 911:40
Conference pass
Chair's Remarks
Compliance, G103
Gloria Bustos, Senior Director, Global Head of Global Patient Safety, Renal Segment, Baxter Healthcare
Oct 911:40
Conference pass
Chair's Remarks
Case Processing, G104
Steve Dingman, Vice President, Independent PV Expert
Oct 911:40
Conference pass
Chair's Remarks
Medical Devices, G105
Sarah Freestone, Vice President, Head of Pharmacovigilance and Device Safety, UCB Pharma
Oct 911:40
Conference pass
Chair's Remarks
Patient Centricity, G106
Alina Ioana Tudor, Global Head, Medical Evaluation and ICSR Review, KYOWA KIRIN
Oct 911:40
Conference pass
Chair's Remarks
Digital Transformation, G107
Claudia Pierleoni-Nielsen, Director, Global Safety Surveillance, LEO Pharma
Oct 911:40
Conference pass
Chair's Remarks
PV Outsourcing, G109
Rita Lobatto, Vice President, Pharmacovigilance & QPPV, Pharming Group
Oct 911:45
Conference pass
Applications and innovations of AI in signal management
AI & Automation, Auditorium
Philip Jones, Senior Director, Disease Area Cluster Lead, Inflammation & Immunology, Pfizer
Oct 911:45
Conference pass
Challenges and opportunities in the new risk minimisation guidance
Risk Management, Exhibition Hall
Speaker presentation - AXIAN
Mohamed Abdillahi, Director, Risk Management Product Lead, Pfizer
Oct 911:45
Conference pass
The use of structured analysis in signal assessment
Signal Detection & Management, Exhibition Hall
Speaker presentation
Chris Bone, Director, Safety and Benefit Risk, Biogen
Oct 911:45
Conference pass
Preparation for inspection readiness: working with multicultural stake-holders
Quality Assurance, G102
Mijal Chavda, Senior Director, Global Head of GxP Inspections & GVP Quality, Kyowa Kirin International
Oct 911:45
Conference pass
Medical reviews of ICSRs: case studies from FDA
Compliance, G103
Riti Shah, Senior Medical Director, Pharmacovigilance, Chiesi
Oct 911:45
Conference pass
Innovations in case management processes: integrating systems with limited budgets
Case Processing, G104
Matteo Barion, Digital Innovation & Technologies Unit Head, QPPV Office, Chiesi Farmaceutici SpA
Oct 911:45
Conference pass
Novel signal detection methods for medical devices
Medical Devices, G105
Sarah Vaughan, Head of Vigilance Operations, MHRA
Oct 911:45
Conference pass
Pharmacovigilance systems in Africa: advancing global health goals
Patient Centricity, G106
Marcin Kruk, Senior Director, Drug Safety Unit Regional Head, Europe, Africa & Middle East, Pfizer
Oct 911:45
Conference pass
Innovation ecosystems within pharmacovigilance
Digital Transformation, G107
James Whitehead, Senior Director, Devices and Digital Safety, Astra Zeneca
Oct 911:45
Conference pass
Overcoming hurdles in managing external suppliers in case processing
PV Outsourcing, G109
Maximilian Jacobs, Head of Vendor Management, Pharmacovigilance, BAYER AG
Oct 912:05
Conference pass
Embracing change: the journey from manual to automated case workflows
AI & Automation, Auditorium
Sponsor Presentation - PharSafer
Graeme Ladds, CEO & Owner, PharSafer
Oct 912:05
Conference pass
Controlled Access Programme design and implementation case study
Risk Management, Exhibition Hall
Sponsor presentation - AXIAN
Kate Bendall, Head of Implementation, Axian Consulting ltd.
Oct 912:05
Conference pass
Leveraging real-world data for improved monitoring and evaluation of safety signals
Signal Detection & Management, Exhibition Hall
Sponsor Presentation - Parexel
Kausik Maiti, Executive Director, Safety Physicians, Parexel International
Oct 912:05
Conference pass
Global and local PV compliance and oversight: challenges and solutions
Quality Assurance, G102
Speaker Presentation - ProductLifeGroup
Lucy Green, Director of Local Safety PV, ProductLife Group
Minyar Chelly Kahloun, Director, of QPPV-LSO & Medical Writing, ProductLife Group
Oct 912:05
Conference pass
EU AI Act and PV compliance
Compliance, G103
Sponsor presentation - Sophos
Raghunandan Murthy, Director, Business Transformation and PV Consulting, Sophos IT Services
Oct 912:05
Conference pass
How to level the playing field in patient safety in 2024 if you are a small or mid-sized pharma organisation
Case Processing, G104
Sponsor presentation - Cognizant
Abhishek Garg, Delivery Director, cognizant
Venkat Venkataramanan, PV Practice Lead, Life Science Operations, cognizant
Oct 912:05
Conference pass
Navigating through EU MDR PSUR
Medical Devices, G105
Sponsor presentation - explic8
Louie Tan, Director, Medical Affairs, ClinChoice
Oct 912:05
Conference pass
Utilizing the measurement of cognition to determine drug safety in late phase clinical trials
Patient Centricity, G106
Sponsor presentation
Oct 912:05
Conference pass
Healthcare-grade AI: practical strategies for transforming PV workflows
Digital Transformation, G107
Sponsor presentation - IQVIA
Marie Flanagan, Director, Product Management, Safety Tech, IQVIA
Updesh Dosanjh, Practice Lead Safety Technology, IQVIA
Oct 912:05
Conference pass
Future-proofing pharmacovigilance: governance, data collection and analyses for global success.
PV Outsourcing, G109
Sponsor presentation - Qinecsa
Martin Holm-Petersen, Chief Executive Officer, Insife - Chief Strategy Officer, Qinecsa Solutions
Oct 912:25
Conference pass
AI safety systems and analytics: innovations for mid-sized biotech companies
AI & Automation, Auditorium
Speaker presentation
Tarak Thakker, Director, Safety Systems and Reporting, BeiGene
Oct 912:25
Conference pass
CAR-T digital approach / system to manage complex compliance and risk minimisation needs
Risk Management, Exhibition Hall
Speaker presentation - AXIAN
Matt Aspinall, Head of Product & Engagement Manager, Axian Consulting ltd.
Oct 912:25
Conference pass
Trial Safety Review Centre (TRISARC) as a team complementing study clinical team and patient safety in clinical trials
Signal Detection & Management, Exhibition Hall
Oct 912:25
Conference pass
Regulatory challenges in quality assurance: producing guidance for the public sector
Quality Assurance, G102
Marco Tuccori, Pharmacovigilance Manager, Coordinator & Co-Chair, University Hospital of Pisa, Tuscan Regional Centre of Pharmacovigilance & ISoP Scientific Board
Oct 912:25
Conference pass
Building compliance oversight in PV systems
Compliance, G103
Irina Maria Ciubotaru, Vice President, Head of Global Drug Safety and Pharmacovigilance, EU & UK QPPV, ITM Isotope Technologies Munich SE
Oct 912:25
Conference pass
Establishing case processing and compliance in social media in small and medium sized enterprises
Case Processing, G104
Oct 912:25
Conference pass
Combination products: combined efforts
Medical Devices, G105
Judy Barretto, Senior Director, Virology TA, Patient Safety, Gilead
Oct 912:25
Conference pass
Benefit risk assessments for patients
Patient Centricity, G106
Stéphanie Tcherny-Lessenot, Global Head, Benefit-Risk Evaluation, Sanofi
Oct 912:25
Conference pass
Assessment of digital health in post market safety – an industry and regulatory landscape
Digital Transformation, G107
Oct 912:25
Conference pass
New models for outsourcing case management: working with ESPs to build processes
PV Outsourcing, G109
Minhaj Obeidullah, Global Head Governance & Risk, Novartis
Oct 912:45
Conference pass
Leveraging Generative AI for aggregate report authoring
AI & Automation, Auditorium
Sponsor presentation - Ultragenic
Lalit Gehani, Director, Analytics and Reporting, Ultragenic
Oct 912:45
Conference pass
Application of behavioural science to risk management: An update
Risk Management, Exhibition Hall
Sponsor presentation - AXIAN
Marie-Claire Wilson, Engagement Manager, Axian Consulting ltd.
Oct 912:45
Conference pass
Practical approaches in signal detection during clinical studies
Signal Detection & Management, Exhibition Hall
John Fitzpatrick, Senior Pharmacovigilance Manager, ProPharma
Oct 912:45
Conference pass
Changing landscape of PV: strategies to win
Quality Assurance, G102
Sponsor presentation - QPD Group
Gorka Ibaibarriaga Ruiz, Pharmacovigilance Coordinator, QBD Group
Oct 912:45
Conference pass
A blueprint for optimizing pharmacovigilance for country affiliates
Compliance, G103
Sponsor presentation - IQVIA
Barry Mulchrone, Head of Safety Science & Strategy Lifecycle Safety, IQVIA
Oct 912:45
Conference pass
Strategies for successfully scaling GenAI PV initiatives from Pilot to Production
Case Processing, G104
Sponsor presentation - Indegene
Nikesh Shah, Vice President and Global Head, Drug Safety and Pharmacovigilance, Indegene
Hans-Jörg Römming, Executive Director, Head of GPS Operations, Merck
Griselda Saldana, Director, Global Safety, Amgen
Oct 912:45
Conference pass
Enabling patient centric pharmacovigilance through global real-world data
Patient Centricity, G106
Sponsor presentation
Robert Kyle, Vice President, Product for Pharmacovigilance, TriNetX
Oct 912:45
Conference pass
Navigating the tech revolution in pharmacovigilance: balancing innovations with regulatory requirements and daily operations
Digital Transformation, G107
Sponsor presentation - NNIT
Slobodan Vucinic, Senior Consultant, NNIT A/S
Oct 912:45
Conference pass
Pharmacovigilance system transfer: ensuring a seamless shift
PV Outsourcing, G109
Sponsor presentation - Insuvia
Ada Stelmakiene, Head of Pharmacovigilance, Insuvia
Oct 913:05
Conference pass
Where could we be in 5 years, what do we need to focus on now?
Risk Management, Exhibition Hall
Speaker presentation - AXIAN
Oct 913:05
Conference pass
Signal detection understanding similarities: medical devices, vaccines and drugs
Signal Detection & Management, Exhibition Hall
Israel Gutierrez, Chief Medical Officer, TLR Therapeutics
Oct 913:05
Conference pass
Building a delegation profile for QPPVs
Quality Assurance, G102
Heike von Treichel, Senior Director, Deputy EU QPPV, Head of PV QMS and QPPV Office, Merck
Oct 913:05
Conference pass
SYNAPSE: A connective, comprehensive, compliance concept
Compliance, G103
Oct 913:05
Conference pass
Integration of case processing in smaller pharmaceutical companies
Case Processing, G104
Johanna Strandell, Director, Patient Safety, Camurus AB
Oct 913:05
Conference pass
Driving patient centricity in pharmacovigilance at a country level
Patient Centricity, G106
Yvonne Nanciu, Country Head, Pharmacovigilance, Deputy EU QPPV, Bayer
Oct 913:05
Conference pass
The future of the PV industry in the next 10 years
Digital Transformation, G107
Oct 913:05
Conference pass
Transforming local safety roles
PV Outsourcing, G109
Begum Benli Peker, Director, Head of Patient Safety Netherlands & EU Hub Lead, Bristol Myers Squibb
Oct 913:25
Conference pass
Lunch
Keynotes
Lunch
Oct 914:25
Conference pass
01 AI & Automation Panel – Innovating in automation: diverse perspectives across the PV industry
AI & Automation, Auditorium
Ranga Reddy, Head of Drug Safety Technologies, Former CSL Vifor
Tjark Reblin, Senior Vice President, Global Head of Patient Safety, Ipsen
Claudia Lehmann, Vice President, Head, Patient Safety & Pharmacovigilance Operations, Boehringer Ingelheim International
Swadhin Khawas, Global Head of Solutions and Capabilities, HCLS, WNS Global Services Ltd
Oct 914:25
Conference pass
03 ArisGlobal Panel – Safeguard your safety technology investment
Signal Detection & Management, Exhibition Hall
Panel Discussion
Moderator: Will Gordon, Senior Vice President, Product Management, Safety, ArisGlobal LLC
Maurice Liemburg, Director, Workflow Management, Pharmacovigilance, Astellas
Attila Oláh, Vice President, Head, Global Patient Safety, EU-QPPV, Gedeon Richter PLC
Jorge Carmona, Global Product Line Lead, Head, Patient Safety Risk Management Informatics, Roche
Yvonne Schäfer, Head of Patient Safety & Pharmacovigilance Systems Business Solutions, Boehringer Ingelheim International
Oct 914:25
Conference pass
04 Quality Assurance Panel – Behind the curtains of inspections: recent advances in GVP inspections
Quality Assurance, G102
Moderator: Mijal Chavda, Senior Director, Global Head of GxP Inspections & GVP Quality, Kyowa Kirin International
Dominic Nguyen-Van-Tam, Senior Pharmacovigilance Inspector, MHRA
Tea Babic, Director, Head of PV Audits and Inspections, Deputy Head PV Compliance, Teva Pharmaceuticals
Oct 914:25
Conference pass
05 Compliance Panel – Global oversight for diverging regulations and business partners: harmonizing stakeholders
Compliance, G103
Moderator: Marco Colombati, PV Operations Manager, ITALFARMACO S.P.A.
Teresa Saragoça, Technical Director and Head of Regulatory Affairs, Italfarmaco PT
Fabio Miceli, EU QPPV, Norgine
Michelle Dardeno, Vice President, Aurinia
Oct 914:25
Conference pass
06 Compliance Panel – New challenges for PV inspection readiness: inspected and inspectors view point
Case Processing, G104
Claire Longman, Expert Pharmacovigilance Inspector, MHRA
Zina Sadeq, Director, Regional PV and Alliance Management, Deputy UK QPPV, Amicus Therapeutics
Diane Halle, Senior Manager, Pharmacovigilance Quality Assurance, Alnylam Pharmaceuticals
Oct 914:25
Conference pass
07 Medical Devices Panel - Different safety approaches between pharma, devices, and combination products
Medical Devices, G105
Judy Barretto, Senior Director, Virology TA, Patient Safety, Gilead
Omar Aimer, Executive Member of ISoP and NASoP President, International Society of Pharmacovigilance (ISoP)
Martha Menzel, Director, Clinical Safety, Edwards Lifesciences
Oct 914:25
Conference pass
08 EVERSANA Panel – The subtle art of simplifying pharmacovigilance
Patient Centricity, G106
08 Reserved Panel – EVERSANA
Moderator: Vivek Ahuja, Senior Vice President, Compliance, EVERSANA
Pav Rishiraj, Director, Head of Patient Safety & ABPI PV Expert Chair, Ipsen & ABPI
Uwe Gudat, Chief Medical Officer, Biocon Biologics
Oct 914:25
Conference pass
09 Digital Transformation Panel - Managing digital health – what are the considerations when implementing digital health to advance safety?
Digital Transformation, G107
Moderator: James Whitehead, Senior Director, Devices and Digital Safety, Astra Zeneca
Phil Tregunno, Deputy Director, Patient Safety Monitoring, Medicines & Healthcare products Regulatory Agency
Oct 915:20
Conference pass
Chair's Remarks
AI & Automation, Auditorium
Chair's Remarks
Bruce Palsulich, Vice President, Safety, Oracle Life Sciences
Oct 915:20
Conference pass
Chair's Remarks
Risk Management, Exhibition Hall
Ana Sofia Afonso, Director, Pharmacoepidemiology, Global Patient Safety, Eli Lilly
Oct 915:20
Conference pass
Chair's Remarks
Signal Detection & Management, Exhibition Hall
Oct 915:20
Conference pass
Chair's Remarks
Quality Assurance, G102
Jutta Syha, Independent PV Expert, Independent PV Expert
Oct 915:20
Conference pass
Chair's Remarks
Compliance, G103
Wasim Anwar, Vice President, Deputy QPPV, Novo Nordisk A/S
Oct 915:20
Conference pass
Chair's Remarks
Case Processing, G104
Chair's Remarks
Oct 915:20
Conference pass
Chair's Remarks
Medical Devices, G105
Chair's Remarks
Joan D'souza, Consultant, Independent PV Expert
Oct 915:20
Conference pass
Chair's Remarks
Patient Centricity, G106
Oct 915:20
Conference pass
Chair's Remarks
Digital Transformation, G107
Attila Oláh, Vice President, Head, Global Patient Safety, EU-QPPV, Gedeon Richter PLC
Oct 915:20
Conference pass
Chair's Remarks
PV Outsourcing, G109
Emma Boulton, Director, Local Safety Operations, Mundipharma
Oct 915:25
Conference pass
Machine learning and emerging technologies in patient safety
AI & Automation, Auditorium
Mark Widdowson, Senior Manager, Digital Capabilities, WorldWide Patient Safety, Bristol Myers Squibb
Oct 915:25
Conference pass
The importance of risk minimisation and implementation principles before commercialisation
Risk Management, Exhibition Hall
Asa Mattsson, Senior Director, Patient Safety Risk Management, Process & Implementation, AstraZeneca
Kristin Knalstad, Director, Risk Management, Patient Safety, AstraZeneca
Oct 915:25
Conference pass
Integration of real-world data into signal management
Signal Detection & Management, Exhibition Hall
Siva Kumar Buddha, Director, Pharmacovigilance, Head of Signals and Risk Management, Indegene Inc.
Oct 915:25
Conference pass
Risk-based auditing, from planning to closure
Quality Assurance, G102
Rebecca Webb, Senior Director, Safety, Vigilance and Medical Affairs QA, AbbVie
Oct 915:25
Conference pass
Compliance metrics for vendors and partners in MENA region
Compliance, G103
Mina G Awad, Pharmacovigilance Senior Manager and QPPV, Middle East, Kyowa Kirin International
Oct 915:25
Conference pass
Continuing the innovation journey in Moderna: clinical trials and case processing
Case Processing, G104
Marta Bałuka, Manager, Global Case Management, PV Operations, Moderna
Olga Błaszczyk, Manager, Global Case Management, PV Operations, Moderna
Oct 915:25
Conference pass
Companion diagnostics at the point of care
Medical Devices, G105
Ioanna Poulida, PhD Candidate, Department of Pharmacy, University of Patras, Greece
Oct 915:25
Conference pass
Patient-centricity across the product lifecycle: not anymore a wish but a reality
Patient Centricity, G106
Oct 915:25
Conference pass
Challenges in using social media for pharmacovigilance
Digital Transformation, G107
Oct 915:25
Conference pass
Different partners and providers for PV outsourcing
PV Outsourcing, G109
Juri Hodisch, Head, Drug Safety, QPPV, Aop Health
Oct 915:45
Conference pass
GxP environments and AI: proven implementations beyond the hype
AI & Automation, Auditorium
Sponsor presentation - iVigee
Jan Petracek, Chief Executive Officer, iVigee
Oct 915:45
Conference pass
Enhancing medical safety: an approach since ergonomics and human factors
Risk Management, Exhibition Hall
Sponsor presentation
Adriana Aristizabal, Medical Director, Vitalis
Oct 915:45
Conference pass
Key aspects of an effective signaling strategy
Signal Detection & Management, Exhibition Hall
Robert Weber, Product Management Director, Oracle Health Sciences
Oct 915:45
Conference pass
Process audits - a mirror to compliance
Quality Assurance, G102
Sponsor presentation - RiverArk
Milind Nadgouda, Director, Operations, RiverArk Limited
Ashok Kumar Giridharilal, Principal GxP QA Auditor, RiverArk Limited
Oct 915:45
Conference pass
DSUR overview and regulatory guidance implementation strategies
Compliance, G103
Sponsor presentation - Siro CLINPHARM
Rupesh Thorat, Head, Drug Safety, SIRO Clinpharm Pvt Ltd
Oct 915:45
Conference pass
Use of AI in pharmacovigilance - challenges and emerging opportunities
Case Processing, G104
Sponsor presentation
Narasimha Kumar, Chief Product and Commercial Officer, Datafoundry
Oct 915:45
Conference pass
Gaps in regulations for drug device combinations
Medical Devices, G105
Sponsor presentation
Joan D'souza, Consultant, Independent PV Expert
Oct 915:45
Conference pass
Enhancing PV education across HCPs: Implementation of an online PV course for pharmacists in Romania - a joint initiative
Patient Centricity, G106
Sponsor presentation
Elena Cucu, Deputy EU QPPV, AbbVie
Oct 915:45
Conference pass
Accelerating business transformation with Generative AI in BioPharma: real world samples
Digital Transformation, G107
Sponsor presentation - HCLTech
Sandesh Prabhu, Global Head, Life Sciences Practices and Solutions, HCL Technologies Ltd.
Oct 915:45
Conference pass
To AI or not to AI
PV Outsourcing, G109
Sponsor presentation - Eversana
Vivek Ahuja, Senior Vice President, Compliance, EVERSANA
Oct 916:05
Conference pass
AI driven solutions for simplifying reporting rules
AI & Automation, Auditorium
Katarzyna Gruchala, Director, PV Operations Global Submissions, Moderna
Oct 916:05
Conference pass
PV audits: pitfalls for the oversight of distributors
Quality Assurance, G102
Hadir Rostom, Independent PV Expert - Lecturer, Modern Sciences And Arts University
Oct 916:05
Conference pass
Training and mentoring compliance in pharmacovigilance: knowledge sharing to enhance global quality
Compliance, G103
Iwona Piotrowska-Potapczyk, Associate Director, Global Pharmacovigilance Case Management, MSD
Ewa Malinowska, Associate Director, Global Pharmacovigilance Case Management, MSD
Oct 916:05
Conference pass
Optimizing case management for SMEs
Case Processing, G104
Oct 916:05
Conference pass
Turning the ambition into a roadmap to ensure quality, speed, consistency and flexibility
Digital Transformation, G107
Yvonne Schäfer, Head of Patient Safety & Pharmacovigilance Systems Business Solutions, Boehringer Ingelheim International
Oct 916:05
Conference pass
Transitions in PV outsourcing: case processing and safety databases
PV Outsourcing, G109
Oct 916:25
Conference pass
Networking Break
Keynotes
Networking Break
Oct 917:05
Conference pass
Chair's Remarks
AI & Automation, Auditorium
Chair's Remarks
Suzanne Foncin, Independent PV Expert
Oct 917:05
Conference pass
Chair's Remarks
Risk Management, Exhibition Hall
Emanuel Lohrmann, Director, PV Therapeutic Area Lead, Cardio Renal, Otsuka Pharmaceuticals
Oct 917:05
Conference pass
Chair's Remarks
Signal Detection & Management, Exhibition Hall
Leith Kwaan, QPPV, National Bioproducts Institute NPC
Oct 917:05
Conference pass
Chair's Remarks
Quality Assurance, G102
Elena Keller, Director, PV, RA, Quality and Medical Operations, Local QPPV, Ipsen Pharma GmbH
Oct 917:05
Conference pass
Chair's Remarks
Compliance, G103
Chair's Remarks
Magda Daudin, Director, Head of PV Operations and Compliance, Idorsia
Oct 917:05
Conference pass
Chair's Remarks
Case Processing, G104
Chair's Remarks
Monika Kowalska, Director, Global Case Management, Moderna
Oct 917:05
Conference pass
Chair's Remarks
Medical Devices, G105
Chair's Remarks
Oct 917:05
Conference pass
Chair's Remarks
Patient Centricity, G106
Oct 917:05
Conference pass
Chair's Remarks
Digital Transformation, G107
Chair's Remarks
Camilla Hammerum, Vice President, Head of GPS TA Oncology, Ipsen
Oct 917:05
Conference pass
Chair's Remarks
PV Outsourcing, G109
Conny Johansson, Alliance Management Lead, Roche
Oct 917:10
Conference pass
How to approach innovation with GenAI in patient safety
AI & Automation, Auditorium
Suzanne Foncin, Independent PV Expert
Oct 917:10
Conference pass
Structured benefit risk assessments
Risk Management, Exhibition Hall
Oct 917:10
Conference pass
Safety monitoring in clinical studies
Signal Detection & Management, Exhibition Hall
Oct 917:10
Conference pass
Inspection readiness & setting up quality management systems for cell & gene therapies
Quality Assurance, G102
Kapil Bhutada, Director of Safety Operations and Compliance, Medical Safety & Pharmacovigilance, Askbio
Oct 917:10
Conference pass
Being inclusive at a global level: ensuring compliance in Taiwan and Korea
Compliance, G103
Ariane Stollenwerk, Director, Head of Central Europe & Asian Int. Markets, International PhV, UCB Pharma
Oct 917:10
Conference pass
Medium sized pharma perspectives for automations in case assessments
Case Processing, G104
Oana Rad, Senior Safety Scientist, B Braun
Oct 917:10
Conference pass
Finding common ground for combination products regarding vigilance
Medical Devices, G105
Ronald Boumans, Independent Medical Devices Expert, EU Medical Devices Expert
Oct 917:10
Conference pass
Management of local PV regulation for global patient safety perspectives
Patient Centricity, G106
Antonella Fretta, Senior Director, Aggregate Reporting Team Lead, Pfizer
Donald Puccio, Senior Director, Team Leader/Business Process Owner Aggregate Reports, Pfizer
Oct 917:10
Conference pass
i-Vigilance initiative leveraging digital transformation and artificial intelligence for enhanced pharmacovigilance compliance at local affiliates level
Digital Transformation, G107
Ibrahim Altamawy, Medical Affairs & Compliance Regional Head (MENA), SAJA Pharmaceuticals
Oct 917:10
Conference pass
Outsourcing of strategic PV activities
PV Outsourcing, G109
Conny Johansson, Alliance Management Lead, Roche
Oct 917:30
Conference pass
Applications of AI in pharmacovigilance
AI & Automation, Auditorium
Sponsor presentation - Transperfect
Christine Buggle, Senior Director, TransPerfect
Oct 917:30
Conference pass
Development RMPs (dRMP): importance in clinical programmes
Risk Management, Exhibition Hall
Sponsor presentation
Claudia Pierleoni-Nielsen, Director, Global Safety Surveillance, LEO Pharma
Oct 917:30
Conference pass
Process audits - a mirror to compliance
Quality Assurance, G102
Sponsor presentation
Milind Nadgouda, Director, Operations, RiverArk Limited
Oct 917:30
Conference pass
Smart steps in AI: ensuring compliance in pharmacovigilance
Compliance, G103
Sponsor presentation
Indy Ahluwalia, PV Consultant, Truliant Consulting
Oct 917:30
Conference pass
The role of medical doctors in risk management
Medical Devices, G105
Sponsor presentation
Oct 917:30
Conference pass
Details matter – outsourcing and simplification considering local affiliate requirements
Patient Centricity, G106
Sponsor presentation
Ekaterina Edle von Dall'Armi, Deputy Local QPPV & Senior Medical Advisor Patient Safety, GSK
Oct 917:30
Conference pass
PV SaaS movement – Expectations and key success factors
Digital Transformation, G107
Fabrice Besle, Director, PV Database & Analytic Reporting, Ipsen
Oct 917:30
Conference pass
Harnessing social media for product quality, safety, and customer-centric operations
PV Outsourcing, G109
Sponsor presentation - ALWIS
Abdul Rahim, Founder Director, ALWIS Solutions Limited
Oct 917:50
Conference pass
Pharmacovigilance intelligence surveillance – End-to-End (E2E) process to assure regulatory compliance
Compliance, G103
Tsambika Fuchs, Team Lead PV Intelligence and Performance Management, Merck Healthcare KGaA
Oct 917:50
Conference pass
MHRA: a digital transformation journey
Digital Transformation, G107
Sarah Vaughan, Head of Vigilance Operations, MHRA
Oct 917:50
Conference pass
QPPV oversight for local safety representatives outsourcing
PV Outsourcing, G109
Anna Stahl, Deputy QPPV, BeiGene
Oct 918:10
Conference pass
Close of conference and drinks reception
Keynotes
Close of conference and drinks reception
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Oct 108:55
Conference pass
Chair's Remarks
Keynotes
Shaloo Pandhi, Global Head, Patient Safety, Sandoz
Oct 109:00
Conference pass
Modernize your PV systems landscape: simplify and standardize to innovate
Keynotes
Session Reserved for Veeva
Jeroen van Doorn, Director, Business System Management & Innovation, MSD
Gianfranco Scibelli, Senior Director, Vault Safety, Europe, Veeva Systems
Oct 109:20
Conference pass
Artificial intelligence in pharmacovigilance at Pfizer: use of large language models
Keynotes
Oct 109:40
Conference pass
Building the future: the journey to developing an integrated, end-to-end safety platform for the drug safety industry
Keynotes
Session Reserved for RxLogix
Raj More, Chief Architect & CEO, RxLogix Corporation
Richard Wolf, Vice President, Client Relations, RxLogix Corporation
Oct 1010:00
Conference pass
Why it is time for the industry to bring in real-world data to drive better patient safety
Keynotes
Session Reserved for Cognizant
Swapnil Babasaheb Khot, Vice President & Delivery Leader Life, Sciences Digital Operations, cognizant
Oct 1010:20
Conference pass
Keynote Panel Discussion - Empowering patients: advancing patient-centric approaches in pharmacovigilance
Keynotes
Shaloo Pandhi, Global Head, Patient Safety, Sandoz
Jens-Ulrich Stegmann, Senior Vice President, Head Clinical Safety and Pharmacovigilance, EU QPPV, GSK
Karsten Lollike, Corporate Vice President, QPPV, Novo Nordisk
Fabian Heisig, Senior Vice President, Head Global Drug Safety & QPPV, Grunenthal
Ercem Atillasoy, Chief Regulatory and Safety Officer, Jazz Pharmaceuticals
Oct 1011:00
Conference pass
Morning Break
Keynotes
Morning Break & Interactive Poster Sessions
Oct 1011:40
Conference pass
Chair's Remarks
Automation, G104
Chair's Remarks
Teodora Perger, Senior Medical Director, Global Safety Physician, AstraZeneca
Oct 1011:40
Conference pass
Chair's Remarks
Artificial Intelligence, Auditorium
Pav Rishiraj, Director, Head of Patient Safety & ABPI PV Expert Chair, Ipsen & ABPI
Oct 1011:40
Conference pass
Chair's Remarks
Risk Management, Exhibition Hall
Frédérique Delannois, Executive Director, Safety Evaluation & Risk Management Head, Global Safety, GSK
Oct 1011:40
Conference pass
Chair's Remarks
Signal Detection & Management, Exhibition Hall
Oct 1011:40
Conference pass
Chair's Remarks
Quality Assurance, G102
Tanja Hoffman, Independent, Independent PV Expert
Oct 1011:40
Conference pass
Chair's Remarks
Compliance, G103
Daniela Di Cosmo, Senior Safety Advisor, Global Safety, Ferring Pharmaceuticals
Oct 1011:40
Conference pass
Chair's Remarks
Medical Devices, G105
Moderation
Richard Mayer, Senior Principal Engineer, Head of Medical Safety R&D, Johnson and Johnson
Oct 1011:40
Conference pass
Chair's Remarks
Patient Centricity, G106
Oct 1011:40
Conference pass
Chair's Remarks
Digital Transformation, G107
Chair's Remarks
Oct 1011:40
Conference pass
Chair's Remarks
PV Outsourcing, G109
Amina Baljic, Senior Director, Head, PV Operations and PV Excellence, Grunenthal
Oct 1011:45
Conference pass
AI application and automation of a probabilistic tool to assess causality
Artificial Intelligence, Auditorium
Fabio De Gregorio, Vice President, Head Of Drug Safety Europe, Shionogi BV
Oct 1011:45
Conference pass
Hyper automation in pharmacovigilance - Unleash the power of automation through integrated and connected technologies
Automation, G104
Oct 1011:45
Conference pass
Differing periodic reports and risk management plans for regulators
Risk Management, Exhibition Hall
Dineke Eikelboom, Associate Director, Medical Safety, Pharmacovigilance, Astellas pharma
Oct 1011:45
Conference pass
The role of AI in global signal detection
Signal Detection & Management, Exhibition Hall
Oct 1011:45
Conference pass
Comparing and contrasting different types of PV audits
Quality Assurance, G102
Ranjana Khanna, Global Director, GVP, QA, R&D Quality, BeiGene
Oct 1011:45
Conference pass
Compliance documentation – does it have to be complicated?
Compliance, G103
Oct 1011:45
Conference pass
Medical safety R&D
Medical Devices, G105
Richard Mayer, Senior Principal Engineer, Head of Medical Safety R&D, Johnson and Johnson
Oct 1011:45
Conference pass
Patient centricity from a safety perspective
Patient Centricity, G106
Ercem Atillasoy, Chief Regulatory and Safety Officer, Jazz Pharmaceuticals
Ilaria Grisoni, Executive Director, Head of EU & International Pharmacovigilance, QPPV Office and EEA QPPV, Jazz Pharmaceuticals
Oct 1011:45
Conference pass
The patient drug safety paradigm in the 2030's
Digital Transformation, G107
Fabio Lievano, Vice President, Safety Science, AbbVie
Oct 1011:45
Conference pass
Optimising outsourcing across affiliates and regions
PV Outsourcing, G109
Majken Berghuis, Director, Pharmacovigilance, International Operations, Novo Nordisk
Oct 1012:05
Conference pass
The Roadmap for PV innovation. The future of technology-led PV innovation from now towards 2030
Artificial Intelligence, Auditorium
Sponsor presentation - Insife
Martin Holm-Petersen, Chief Executive Officer, Insife - Chief Strategy Officer, Qinecsa Solutions
Oct 1012:05
Conference pass
Unlocking the power of GenAI in life sciences
Automation, G104
The integration of Generative AI in life sciences is transforming the industry, moving from theoretical exploration to practical application. This session will delve into the tangible benefits and strategic implementation of GenAI, covering its current and surprising capabilities, as well as its future potential. Join us for an engaging discussion on:
Capabilities - A Reality Beyond Imagination: Discover the unprecedented capabilities offered by GenAI and hear how these capabilities are stimulating new approaches within the life sciences sector.
Industry Starting Points: Explore common corporate starting points for adopting GenAI, focusing on quality and efficiency. Understand why these areas are pivotal for initial implementation and how they drive significant value.
Product Vision & Approach: Gain insights into our product vision, how we plan for anticipated capabilities, how we are future-proofing with our NavaX engine, and how we ensure the critical human element of this digital transformation is successful.
Practical Demonstration: Witness a live demo showcasing dynamic data extraction and narrative generation. See firsthand the impact on quality and efficiency, and hear our views on the industry imperative and future trajectory.
Don’t miss this opportunity to learn how GenAI is unlocking new possibilities in life sciences and how your organization can accelerate the application of advanced capabilities in life sciences R&D technology.
Jason Bryant, Vice President, Data & AI, ArisGlobal
Will Gordon, Senior Vice President, Product Management, Safety, ArisGlobal LLC
Oct 1012:05
Conference pass
Enhancing patient safety through comprehensive risk management plan oversight
Risk Management, Exhibition Hall
Oct 1012:05
Conference pass
Automated and centralised approach to enhance signal detection and surveillance efficiency for SMEs
Signal Detection & Management, Exhibition Hall
Sponsor presentation - PubHive Ltd
Raj Vaghela, Chief Executive Officer, PubHive Ltd.
Maja Barac, Chief Executive Officer & EU QPPV, Pharmavigil
Oct 1012:05
Conference pass
PV outsourcing - from industry to service provider, and back
Quality Assurance, G102
Sponsor presentation
Martijn van de Leur, Chief Operating Officer PV/RA/MI, Biomapas
Oct 1012:05
Conference pass
Bridging compliance gaps in risk minimisation measures: plan to performance evaluation
Compliance, G103
Sponsor presentation
Oct 1012:05
Conference pass
New standards for clinical evaluations of medical devices: upcoming ISO standards
Medical Devices, G105
Sponsor presentation
Milos Stojkovic, Safety Process Director, Roche
Oct 1012:05
Conference pass
Building patient-centric PV partnerships
Patient Centricity, G106
Sponsor presentation
Sonia Mangnoesing, Director, Global Drug Safety, Arriello sro
Oct 1012:05
Conference pass
Technology’s impact on the safety business process
Digital Transformation, G107
Sponsor presentation
Sameer Thapar, Strategic Client Advisor, Oracle Life Sciences
Michael Braun-Boghos, Senior Director, Safety Strategy, Oracle Health Sciences
Oct 1012:05
Conference pass
Best practices when outsourcing PV services at the local and regional level
PV Outsourcing, G109
Alex Brenchat, Vice President, Local Pharmacovigilance Services, PharmaLex
Oct 1012:15
Conference pass
Effective management strategies for development safety update reports amid challenges and complexities
Risk Management, Exhibition Hall
Mugdha Chopra, Co-Founder and Director, AWINSA Life Sciences
Oct 1012:25
Conference pass
Application of machine translations (MT) and AI technologies in end-to-end case processing
Automation, G104
Achilleas Kalogirou, Lead, Office of Safety Operations, AbbVie
Oct 1012:25
Conference pass
Generative AI and pharmacovigilance writing - a winning combination
Artificial Intelligence, Auditorium
Pharma Speaker - Insife
Victor Hamel, Product Manager, Quartica, Inc.
Oct 1012:25
Conference pass
Contraception in clinical trials
Risk Management, Exhibition Hall
Oct 1012:25
Conference pass
Safety management in cell and gene therapies
Signal Detection & Management, Exhibition Hall
Céline Muffang, Associate Director, Medical Safety & Pharmacovigilance, Askbio
Asif Mahmood, Vice President, Medical Safety & Pharmacovigilance, Askbio
Oct 1012:25
Conference pass
Don't be a CrAPA…do the CAPA
Quality Assurance, G102
Erika Barbarosie, Associate Director, Compliance, Gilead Sciences
Oct 1012:25
Conference pass
PV Down Under: experiences from a TGA inspection
Compliance, G103
Oct 1012:25
Conference pass
Safety and security of AI powered medical devices
Medical Devices, G105
Oct 1012:25
Conference pass
Safety monitoring of patients in advanced therapies trials
Patient Centricity, G106
David Chonzi, Independent Pharma Physician, Independent PV Expert
Oct 1012:25
Conference pass
Improving mechanistic understanding of adverse events by modelling biological mechanisms
Digital Transformation, G107
Thomas Nirnberger, Chief Executive Officer, Biofi
Uwe Schühly, Head of Drug Safety and Pharmacovigilance, Santhera Pharmaceuticals
Oct 1012:25
Conference pass
From transition to transformation: improving quality and speed of delivery for patient safety
PV Outsourcing, G109
Justin Joubert, Senior Director, Acquisitions, PV Agreements & Contract Liason, GSK
Oct 1012:45
Conference pass
Enhancing drug safety with AI and NLP: innovations for efficient decision-making
Artificial Intelligence, Auditorium
Sponsor presentation - IQVIA
Jane Reed, Director, NLP, Applied AI Science, IQVIA
Oct 1012:45
Conference pass
Medical literature monitoring: integrating local and global
Automation, G104
Sponsor presentation
Oct 1012:45
Conference pass
Navigating the risk minimization tracking landscape: leveraging technology for streamlined, standardized and harmonized commitments tracking
Risk Management, Exhibition Hall
Sponsor presentation - Orbit by Feith Systems
Kevin Fetterman, Executive Director, Orbit, Orbit By Feith Systems
Oct 1012:45
Conference pass
Exploring signal detection in early phase clinical drug trials: focus on drug-induced liver injury (DILI)
Signal Detection & Management, Exhibition Hall
Sponsor presentation - Soterius
Sumit Verma, President, Clinical Safety and Pharmacovigilance Operations, Soterius, Inc.
Oct 1012:45
Conference pass
Inspection in gene therapies: different approaches and experiences
Quality Assurance, G102
Sponsor presentation
Elisabetta Di Martino, Director, GCP, GVP & GLP, Quality Assurance, Orchard Therapeutics
Oct 1012:45
Conference pass
The importance of good collaboration between different vendors to ensure compliance with the global/local regulations
Compliance, G103
Sponsor presentation
Myrto Ioannidi, Director, Global Case Processing, UBC
Esther Aparicio, Team Manager, Global Case Processing, UBC
Oct 1012:45
Conference pass
Developing risk management plans for cell and gene therapies
Patient Centricity, G106
Sponsor presentation
Oct 1012:45
Conference pass
AI/ML – opportunities in pharmacovigilance
Digital Transformation, G107
Sponsor presentation
Sarah Sendrup, CCO & Principal Consultant, Herax
Oct 1012:45
Conference pass
MDR: How integrated workflows can support your Clinical Evaluation Report (CER)
PV Outsourcing, G109
Sponsor presentation
Oct 1013:05
Conference pass
Large language models for causality assessment
Artificial Intelligence, Auditorium
Maurizio Sessa, Associate Professor, Pharmacovigilance and Pharmacoepidemiology, University of Copenhagen
Oct 1013:05
Conference pass
Raising foundational digital dexterity across patient safety
Automation, G104
Speaker presentation
Mark Widdowson, Senior Manager, Digital Capabilities, WorldWide Patient Safety, Bristol Myers Squibb
Oct 1013:05
Conference pass
Effectiveness of risk minimization measures in Europe
Risk Management, Exhibition Hall
Maha Lakshmi Elluri, Global Safety Director, EEA/UK QPPV, Indivior Pharmaceuticals
Oct 1013:05
Conference pass
Signal detection for orphan diseases
Signal Detection & Management, Exhibition Hall
Alexandru Barbarosie, EU/UK QPPV, Global Safety Lead, Amryt Pharma
Oct 1013:05
Conference pass
Auditing PV databases
Quality Assurance, G102
Milind Nadgouda, Director, Operations, RiverArk Limited
Oct 1013:05
Conference pass
Towards a patient-centric shift: reinventing adherence in tuberculosis care
Patient Centricity, G106
Nibedita Rath, Scientific Director, Open Source Pharma Foundation
Oct 1013:05
Conference pass
PSMF spotlight – how connecting data will improve your processes
Digital Transformation, G107
Christian Schmitz-Moormann, Life Sciences Facilitator, Generis
Naomi Bradley, Client Delivery Manager, Generis
Oct 1013:05
Conference pass
Utilising compliance ICSR metrics and PSR for vendor oversight
PV Outsourcing, G109
Melanie Dullemond, PV Compliance Head, Medical and PV Quality, Sanofi
Oct 1014:25
Conference pass
01 Regulatory Agency Panel - Harmonising PV operations across the globe
Artificial Intelligence, Auditorium
Moderator: Myriam Salem, National Good Pharmacovigilance Practices Inspection Program Coordinator, Health Canada
Elena Prokofyeva, Head of Drug Safety Unit, DG Post, FAMHP - Federal Agency for Medicines and Health Products in Belgium
Claire Longman, Expert Pharmacovigilance Inspector, MHRA
Oct 1014:25
Conference pass
06 Signal Detection & Management Panel – Safety related posts to agency websites and submissions excluding label updates
Automation, G104
Veronica Fjellstrom, Global Head, Pharmacovigilance and Patient Safety, Oncopeptides AB
Nayanika Rivankar, Signal Management Strategy Lead, Merck Group
Phillip Eichorn, Global Head of Drug Safety, Chiesi
Oct 1014:25
Conference pass
02 Risk Management Panel – QPPV Oversight for risk management planning and execution
Risk Management, Exhibition Hall
Moderator: Ilaria Grisoni, Executive Director, Head of EU & International Pharmacovigilance, QPPV Office and EEA QPPV, Jazz Pharmaceuticals
Valentina Mancini, Senior Director, Pharmacovigilance, EU & UK QPPV, Shionogi & TransCelerate
Margherita D'Antuono, EU-UK QPPV, Piramal Critical Care
Laura Paola Boga, Senior Director, Head of Global Pharmacovigilance, UK & EU QPPV, Dompé Farmaceutici SpA
Oct 1014:25
Conference pass
03 Signal Detection & Management Panel – Integration of real-world data into signal detection activities
Signal Detection & Management, Exhibition Hall
Moderator: Akhilesh Chamediya, Global Medical Director, Patient Safety Lead, AstraZeneca & Alexion
Maulik Mehta, President, Safety and Pharmacovigilance, TriNetX
Tom Organ, Safety Science Director, Neuroscience TA, Global Patient Safety, IPSEN
Stéphanie Tcherny-Lessenot, Global Head, Benefit-Risk Evaluation, Sanofi
Oct 1014:25
Conference pass
04 Quality Assurance Panel – Quality oversight of non-interventional studies
Quality Assurance, G102
Valerie Vandevoorde, Executive Director, Global Pharmacovigilance Quality Head, Merck
Jolanda De Bruijne, Senior Director, Head of PV Compliance, Teva Pharmaceuticals
Oct 1014:25
Conference pass
05 Compliance Panel – Optimizing PSMFs for inspection findings
Compliance, G103
Moderator: Monika Manske, Associate Director, Lead Quality Management and Deputy EEA QPPV, Viatris
Jan Cleerbout, Deputy QPPV, Johnson & Johnson Innovative Medicine
Rafael Josupeit, EEA QPPV, Procter & Gamble
Balaji Sainath Malla, Head of Pharmacovigilance, QPPV- EU & UK, Dr. Reddy's Laboratories Inc
Nadine Schreiber, Head, Global Pharmacovigilance, medac GmbH
Oct 1014:25
Conference pass
07 Risk Management Panel – Continuous professional training for medicine related stakeholders and patients
Medical Devices, G105
Galina Cordero, Head of Pharmacovigilance Department, QPPV, JSC Farmak
Nathan Rivers, Associate Director, Medical Safety, Oncology, Jazz Pharmaceuticals
Miriam Marotti, Senior Medical Director, Patient Safety Oncology, AstraZeneca
Devi Padmanaban, Executive Medical Director, Neurocrine Biosciences
Oct 1014:25
Conference pass
08 Patient Centricity Panel – Shared decision-making in patient centricity, is it safe?
Patient Centricity, G106
Moderator: Mary Lynne van Poelgeest-Pomfret, President, World Federation for Incontinence and Pelvic Problems (WFIPP)
Amelie Fassbender, Regional Medical Director, Developed Markets, Viatris
Mark Daniels, Director, Safety Physician, Jazz Pharmaceuticals
Amit Aggarwal, Executive Director, Medical Affairs & Strategic Partnerships, ABPI
Oct 1014:25
Conference pass
09 PV Outsourcing Panel – Evolution of outsourcing: highlights and challenges for vendor management
Digital Transformation, G107
09 Reserved Panel
Moderator: Kathy Roberts, Vice President, Global Phamacovigilance, Incyte Corp.
Erica Bavol, Senior Director, Head of Safety Operations, Compliance and Systems, Corcept
Martin Sournac, Manager, Global Pharmacovigilance operations, Incyte
Abiola David, Senior Director, Global Process Owner, ICSR Management, PV Operations, GSK
Eniko Barta Kondas, Head, Global PV Operations, Gedeon Richter PLC
Oct 1014:25
Conference pass
10 Risk Management Panel – Benefit risk management and assessments: engaging patients
PV Outsourcing, G109
Moderator: Luiz Lima, Vice President, Head of Neuroscience, Global Patient Safety, IPSEN
John Solomon, Head of Pharmacovigilance, UK & Ireland, Sanofi
Marcin Marciniak, Senior Director, Global Safety and PV Expert WHC, Gedeon Richter Switzerland
Anna Pelnikevich, Director, Head of Benefit-Risk Management, Merck
Oct 1015:20
Conference pass
Chair's Remarks
Artificial Intelligence, Auditorium
Chair's Remarks
Oct 1015:20
Conference pass
Chair's Remarks
Risk Management, Exhibition Hall
Chair's Remarks
Joanna Han, Independent PV Expert
Oct 1015:20
Conference pass
Chair's Remarks
Signal Detection & Management, Exhibition Hall
Chair's Remarks
Oct 1015:20
Conference pass
Chair's Remarks
Quality Assurance, G102
Chair's Remarks
Isabella Caramuta, Deputy QPPV, Shionogi BV
Oct 1015:20
Conference pass
Chair's Remarks
Compliance, G103
Chair's Remarks
Oct 1015:20
Conference pass
Chair's Remarks
Patient Centricity, G106
Chair's Remarks
Krupa Patel, Senior Safety Scientist, Global Patient Safety, IPSEN
Oct 1015:20
Conference pass
Chair's Remarks
Digital Transformation, G107
Chair's Remarks
Nathalie Joffre, Global Vigilance Director, EU QPPV, Biocodex, Inc.
Oct 1015:20
Conference pass
Chair's Remarks
PV Outsourcing, G109
Chair's Remarks
Oct 1015:25
Conference pass
Advancing AI for PV professionals
Artificial Intelligence, Auditorium
Oct 1015:25
Conference pass
Harmonizing local activities to improve PV efficiency
Risk Management, Exhibition Hall
Marjan Dzeparoski, RA and PV Manager, Bionika Pharmaceuticals
Oct 1015:25
Conference pass
First year of competitive safety monitoring of the Pfizer & GSK RSV mass vaccination in the United States
Signal Detection & Management, Exhibition Hall
Lionel Van Holle, Founder, OpenSourcePV
Oct 1015:25
Conference pass
Local and regional divestment: PV collaboration and quality assurance for database transfers
Quality Assurance, G102
Lynne Comiskey, Divestment Coordination Lead, Sanofi
Oct 1015:25
Conference pass
Fostering end to end collaboration between regulatory and safety organisations for RSI
Compliance, G103
Oct 1015:25
Conference pass
Sharing is caring – how sharing safety science insights helps affiliate PV teams realize the PV value proposition
Patient Centricity, G106
Vivien Stettner, Director, International PSEQ Strategy & Sites, AbbVie
Oct 1015:25
Conference pass
Preparing drug safety data for AI: best practices and key considerations for maximizing accuracy and compliance
Digital Transformation, G107
Sam Kay, Vice President, Pharma, Basil Systems
Oct 1015:25
Conference pass
Effects of outsourcing on key PV activities: differences from large to small sized pharma
PV Outsourcing, G109
Speaker presentation
Mette Stie Kallesøe, Head of Pharmacovigilance, QPPV, Hansa Biopharma
Oct 1015:45
Conference pass
The regulatory landscape of AI: the current state and future trends
Artificial Intelligence, Auditorium
Sponsor presentation - Primevigilance
Nikodem Latocha, Associate Director, Computerised Systems Quality, PrimeVigilance
Oct 1015:45
Conference pass
Minimizing risk with your PV procurement business partners
Risk Management, Exhibition Hall
Sponsor presentation
Mark Cawley, Associate Director, R&D Procurement, Jazz Pharmaceuticals
Oct 1015:45
Conference pass
Article 20 procedure for JAKis - learnings from the safety physician
Signal Detection & Management, Exhibition Hall
Sponsor presentation
Ivana Vranic, Director, Safety Risk Lead, Inflammation & Immunology, Pfizer
Oct 1015:45
Conference pass
The role of drug safety in due diligences
Quality Assurance, G102
Sponsor presentation
Giovanni Furlan, Director, Worldwide Safety Site Lead, Pfizer
Oct 1015:45
Conference pass
Harmonising PSSFs and fulfilling requirements of local agencies
Compliance, G103
Sponsor presentation
Oct 1015:45
Conference pass
Real world evidence within reverse translation
Patient Centricity, G106
Sponsor presentation
Jost Leemhuis, Safety Science Partner and Global Business Lead, Roche
Oct 1015:45
Conference pass
Digital transformation: small steps versus giant leaps
Digital Transformation, G107
Sponsor presentation
Andrew Moore, Director, PV Operations and Compliance, Takeda
Oct 1015:45
Conference pass
Experiences of outsourcing in critical PV activities: ICSRs processing, aggregate reports and literature reviews
PV Outsourcing, G109
Sponsor presentation
Anna Kończak, EU QPPV, Polpharma
Oct 1016:05
Conference pass
AI in predictive safety
Artificial Intelligence, Auditorium
Speaker presentation
Sriram Venkateswaran, Safety Data Science Director, Hoffmann la Roche Ltd
Oct 1016:05
Conference pass
Common platforms for education materials in differing geographies
Risk Management, Exhibition Hall
Cristina Hentea, Director, Safety Surveillance and Risk Management, Viatris
Oct 1016:05
Conference pass
Challenges in creating PV standards across Ukraine and CEE
Quality Assurance, G102
Galina Cordero, Head of Pharmacovigilance Department, QPPV, JSC Farmak
Oct 1016:05
Conference pass
Vaccine pharmacovigilance in Africa – lessons learnt
Patient Centricity, G106
Oct 1016:05
Conference pass
PV vendors qualifications and their oversight
PV Outsourcing, G109
Speaker presentation
last published: 07/Oct/24 14:56 GMT
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