Amsterdam, 9 - 10 October 2024

Schedule

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Oct 98:55
Conference pass

Chair's Remarks

Keynotes
Mariette Boerstoel Streefland, Senior Vice President, Worldwide Patient Safety Officer, Bristol Myers Squibb
Oct 99:00
Conference pass

Keynote presentation

Keynotes
Serban Ghiorghiu, Chief Safety Officer, AstraZeneca
Oct 99:40
Conference pass

Enhancing medicines safety through external databases and artificial intelligence

Keynotes
Felix Arellano, Senior Vice President, Global Head of Safety and Risk Management, Roche
Oct 910:20
Conference pass
Oct 911:40
Conference pass

Chair's Remarks

AI & Automation
Peter De Veene, Associate Vice President, Global QPPV, MSD
Oct 911:40
Conference pass

Chair's Remarks

Signal Detection & Management
Oct 911:40
Conference pass

Chair's Remarks

Compliance
Gloria Bustos Busto, Senior Director, Head of Pharmacovigilance, EMEA & APAC / Global Patient Safety, Baxter Healthcare
Oct 911:40
Conference pass

Chair's Remarks

Case Processing
Garry Flounders, Global Pharmacovigilance Operations Lead, Biosimilars, Biogen
Oct 911:40
Conference pass

Chair's Remarks

Medical Devices
Sarah Freestone, Vice President, Head of Pharmacovigilance and Device Safety, UCB Pharma
Oct 911:40
Conference pass

Chair's Remarks

Patient Centricity
Wally Landsberg, Vice President, Global Head Medical Safety, Kyowa Kirin, Inc.
Oct 911:40
Conference pass

Chair's Remarks

Digital Transformation
Oct 911:40
Conference pass

Chair's Remarks

PV Outsourcing
Rita Lobatto, Vice President Pharmacovigilance & QPPV, Pharming Group
Oct 911:45
Conference pass
Oct 911:45
Conference pass

Connecting signal management and benefit-risk assessments

Signal Detection & Management
Dimitrios Zampatis, Global Program Safety Lead, Global Patient Safety, Sandoz
Oct 911:45
Conference pass

Preparation for inspection readiness: working with multicultural stake-holders

Quality Assurance
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
Riti Shah, Medical Director, Pharmacovigilance, Chiesi
Oct 911:45
Conference pass

Delegating and verifying case processing: diverging regulatory requirements and harmonizing best practices

Case Processing
Nancy Dubois, Senior Director, Head of Global Patient Safety, US Region, EMD Serono
Oct 911:45
Conference pass

Novel signal detection methods for medical devices

Medical Devices
Sarah Vaughan, Head of Vigilance Operations, MHRA
Oct 911:45
Conference pass

Pharmacovigilance systems in Africa: advancing global health goals

Patient Centricity
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
James Whitehead, Senior Director, Devices and Digital Safety, Astra Zeneca
Oct 911:45
Conference pass

What successful outsourcing can look like in small pharma

PV Outsourcing
Lisa Lawrence-Miyasaki, Vice President, Head of Pharmacovigilance, Alumis
Oct 912:25
Conference pass

PharmaVigiPredict: A pilot, predictive surveillance model in pharmacovigilance using artificial intelligence

AI & Automation
Meenal Patwardhan, Vice President, AbbVie
Oct 912:25
Conference pass

Signal management for AAV gene therapies: advancements and challenges

Signal Detection & Management
Mason Shih, Vice President, Safety Science, BioMarin Pharmaceutical Inc.
Oct 912:25
Conference pass

Regulatory challenges in quality assurance: producing guidance for the public sector

Quality Assurance
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
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
Oct 912:25
Conference pass

Title TBC

Medical Devices
Sylvie Bartus, Senior Director, Clinical Safety Global, Clinical Affairs, Surgical Structural Heart, Edwards Lifesciences
Oct 912:25
Conference pass

Benefit risk assessments for patients

Patient Centricity
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
Oct 912:25
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New models for outsourcing case management: working with ESPs to build processes

PV Outsourcing
Minhaj Obeidullah, Head, Compliance and Risk Management, Novartis
Oct 912:45
Conference pass

Practical approaches in signal detection during clinical studies

Signal Detection & Management
John Fitzpatrick, Senior Pharmacovigilance Manager, ProPharma
Oct 913:05
Conference pass

Applications and innovations of AI in signal management

AI & Automation
Philip Jones, Senior Director, Disease Area Cluster Lead, Inflammation & Immunology, Pfizer
Oct 913:05
Conference pass

Signal detection understanding similarities: medical devices, vaccines and drugs

Signal Detection & Management
Israel Gutierrez, Chief Medical Officer, TLR Therapeutics
Oct 913:05
Conference pass

Building a delegation profile for QPPVs

Quality Assurance
Heike von Treichel, Senior Director, Deputy EU QPPV, Head of PV QMS and QPPV Office, Merck
Oct 913:05
Conference pass

Driving a compliant culture through the QPPV office

Compliance
Jessica Mårlind Würtele, Director, Patient Safety Excellence, AstraZeneca
Oct 913:05
Conference pass

Integration of case processing in smaller pharmaceutical companies

Case Processing
Johanna Strandell, Director Patient Safety, Camurus AB
Oct 913:05
Conference pass

Changing legislation across geographies for medical devices

Medical Devices
Judy Barretto, Senior Global Process Director, Signal Management, Roche
Oct 913:05
Conference pass

Driving patient centricity in pharmacovigilance at a country level

Patient Centricity
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
Oct 913:05
Conference pass

Transforming local safety roles

PV Outsourcing
Begum Benli Peker, Director, Head of Patient Safety Netherlands & EU Hub Lead, Bristol Myers Squibb
Oct 914:25
Conference pass

01 AI & Automation Panel – Innovating in automation: diverse perspectives across the PV industry

AI & Automation
Arvind Bellur, Executive Director, Head, PV Innovation and Transformation, CSL Behring
Finn Larsen, Head, Technology and Data Management, Sandoz Patient Safety
Uwe Gudat, Chief Medical Officer, Biocon Biologics
Claudia Lehmann, Vice President, Head, Patient Safety & Pharmacovigilance Operations, Boehringer Ingelheim International
Oct 914:25
Conference pass

02 Risk Management Panel – Benefit risk management and assessments: engaging patients

Risk Management
Luiz Lima, Vice President, Head of Neuroscience, Global Patient Safety, Ipsen
Marcin Marciniak, Senior Director, Global Safety and PV Expert WHC, Gedeon Richter Switzerland
Sunita Dhar, Executive Medical Group Director, Clinical Safety, Genentech
Oct 914:25
Conference pass

03 Signal Detection & Management Panel – Safety related posts to agency websites and submissions excluding label updates

Signal Detection & Management
Willemijn Van Der Spuij, Executive Director, International Patient Safety, Bristol-Myers Squibb
Jean-Christophe Delumeau, Board Director, Institute of Pharmacovigilance
Oct 914:25
Conference pass

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

Quality Assurance
Tea Babic, Director, Head of PV Audits and Inspections, Deputy Head PV Compliance, Teva Pharmaceuticals
Raj Bhogal, Senior Director, R&D Business Strategy & Operations, Jazz Pharmaceuticals
Oct 914:25
Conference pass

05 Compliance Panel – Global oversight for diverging regulations and business partners: harmonizing stakeholders

Compliance
Michelle Motta Dardeno, Vice President, Head, Global Patient Safety, Aurinia
Marco Colombati, PV Operations Manager, ITALFARMACO S.P.A.
Oct 914:25
Conference pass

06 Compliance Panel – Global oversight for diverging regulations and business partners: harmonizing stakeholders

Case Processing
Diane Halle, Senior Manager, Pharmacovigilance Quality Assurance, Alnylam Pharmaceuticals
Anne Raison, Head of Quality and Medical Compliance Management, ROCHE SAS France
Oct 914:25
Conference pass

07 Medical Devices Panel - Different safety approaches between pharma, devices, and combination products

Medical Devices
Judy Barretto, Senior Global Process Director, Signal Management, Roche
Omar Aimer, Executive Committee member of ISoP; Founder of InnoVigilance, Innovigilance
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
James Whitehead, Senior Director, Devices and Digital Safety, Astra Zeneca
Phil Tregunno, Deputy Director, Patient Safety Monitoring, Medicines & Healthcare products Regulatory Agency
Anastasia Ukhova, Global Medical Head, Digital Healthcare, Sanofi
Oct 915:20
Conference pass

Chair's Remarks

Risk Management
Ana Sofia Afonso, Director, Pharmacoepidemiology, Global Patient Safety, Eli Lilly
Oct 915:20
Conference pass
Oct 915:20
Conference pass

Chair's Remarks

Quality Assurance
Jutta Syha, Independent PV Expert
Oct 915:20
Conference pass

Chair's Remarks

Compliance
Wasim Anwar, Vice President, Deputy QPPV, Novo Nordisk A/S
Oct 915:20
Conference pass
Oct 915:20
Conference pass

Chair's Remarks

Digital Transformation
Attila Oláh, Vice President, Head, Global Patient Safety, EU-QPPV, Gedeon Richter PLC
Oct 915:20
Conference pass

Chair's Remarks

PV Outsourcing
Emma Boulton, Director, Safety Operations, Mundipharma
Oct 915:25
Conference pass

Automation in aggregate reporting with the help of AI

AI & Automation
Robert Di Giovanni, Senior Global Patient Safety Lead, Novartis
Oct 915:25
Conference pass

Procedure and RMP governance: challenges and solutions for the PV sector

Risk Management
Kristin Knalstad, Director, Risk Management, Patient Safety, AstraZeneca
Asa Mattsson, Senior Director, Patient Safety Risk Management, Process & Implementation, AstraZeneca
Oct 915:25
Conference pass

Integration of real-world data into signal management

Signal Detection & Management
Siva Kumar Buddha, Global Pharmacovigilance Physician, Senior Manager, Teva Pharmaceuticals
Oct 915:25
Conference pass

The changing landscape of PV inspections

Quality Assurance
Smruti Kothari, Associate Director, PV QA, Jazz Pharmaceuticals
Oct 915:25
Conference pass

Compliance metrics for vendors and partners in MENA region

Compliance
Mina G Awad, Pharmacovigilance Senior Manager and QPPV, Middle East, Kyowa Kirin International
Oct 915:25
Conference pass

Monitoring compliance in case processing

Case Processing
Katarzyna Gruchala, Director, PV Operations Global Submissions, Moderna
Oct 915:25
Conference pass

Integrating patient voices in risk minimization measures

Patient Centricity
Robert Massouh, Head, Risk Management and Benefit-Risk Evaluation, GSK
Oct 915:25
Conference pass

Continuing the innovation journey in Moderna: clinical trials and case processing

Digital Transformation
Monika Kowalska, Director, Global Case Management, Moderna
Oct 915:25
Conference pass

Different partners and providers for PV outsourcing

PV Outsourcing
Juri Hodisch, Head, Drug Safety, QPPV, AOP Health
Oct 916:05
Conference pass

Machine learning and emerging technologies in patient safety

AI & Automation
Sibel Guerler, Senior Director, Head of Innovation, Partnerships and Process Optimisation, WorldWide Patient Safety, Bristol Myers Squibb
Oct 916:05
Conference pass

Variated control distribution systems for biosimilars: managing risk minimization

Risk Management
John Hart, Director, EEA & UK QPPV, Samsung Bioepis NL B.V
Oct 916:05
Conference pass

Safety management in phase 1 studies

Signal Detection & Management
Sutirtha Mukhopadhyay, Senior Associate Director, Senior Patient Safety Physician, Boehringer Ingelheim
Oct 916:05
Conference pass

PV audits: pitfalls for the oversight of distributors

Quality Assurance
Hadir Rostom, Independent PV Expert - Lecturer, Modern Sciences And Arts University
Oct 916:05
Conference pass

Involvement for partner-ship management in Merck Healthcare

Compliance
Marko Strott, Associate Director, Partnership Management, Global Patient Safety, Merck
Oct 916:05
Conference pass

Optimizing case management for SMEs

Case Processing
Oct 916:05
Conference pass

Gaps in regulations for drug device combinations

Medical Devices
Dr. Joan D'souza, Independent PV Expert
Oct 916:05
Conference pass

RA and safety joining forc-es for patient centricity

Patient Centricity
Markus Drumm, Head of Global Patient Safety Regions, Merck Healthcare KGaA
Oct 916:05
Conference pass

Challenges in using social media for pharmacovigilance

Digital Transformation
Oct 916:05
Conference pass

Transitions in PV outsourcing: case processing and safety databases

PV Outsourcing
Oct 917:05
Conference pass

Chair's Remarks

Signal Detection & Management
Leith Kwaan, QPPV, National Bioproducts Institute NPC
Oct 917:05
Conference pass

Chair's Remarks

PV Outsourcing
Vipin Sethi, Head of Global Pharmacovigilance And Medical Affairs, Cadila Pharmaceuticals
Oct 917:10
Conference pass

AI safety systems and analytics: innovations for mid-sized biotech companies

AI & Automation
Tarak Thakker, Director, Head of Safety Systems and Analytics, BeiGene
Oct 917:10
Conference pass

Structured benefit risk assessments

Risk Management
Marta Pujol, Senior Director, Patient Safety, AstraZeneca
Oct 917:10
Conference pass

Safety monitoring in clinical studies

Signal Detection & Management
Oct 917:10
Conference pass

Risk-based auditing, from planning to closure

Quality Assurance
Rebecca Webb, Senior Director, Safety, Vigilance and Medical Affairs QA, AbbVie
Oct 917:10
Conference pass

Being inclusive at a global level: ensuring compliance in Taiwan and Korea

Compliance
Ariane Stollenwerk, Director, Head of Central Europe & Asian Int. Markets, International PhV, UCB Pharma
Oct 917:10
Conference pass

Software as a medical device: SaMD

Medical Devices
Ben Kitchens, Associate Director, Medical Devices, Diagnostics Lead, Otsuka Pharmaceutical Companies (U.S.)
Oct 917:10
Conference pass

Enhancing PV education across HCPs: Implementation of an online PV course for pharmacists in Romania - a joint initiative

Patient Centricity
Elena Cucu, Deputy EU QPPV, AbbVie
Oct 917:10
Conference pass

iVigilance: aligning digital transformation and regulations with local LSRs

Digital Transformation
Ibrahim Altamawy, Medical Affairs & Compliance Regional Head (MENA), SAJA Pharmaceuticals
Oct 917:10
Conference pass

Outsourcing of strategic PV activities

PV Outsourcing
Conny Johansson, Alliance Management Lead, Roche
Oct 917:50
Conference pass

NLP system performance evaluation and analysis

AI & Automation
Marina Suvakov, Global Head, Product Safety Surveillance, Philip Morris International
Oct 917:50
Conference pass

Development RMPs (dRMP): importance in clinical programmes

Risk Management
Claudia Pierleoni-Nielsen, Director, Global Safety Surveillance, LEO Pharma
Oct 917:50
Conference pass

Signal detection for orphan diseases

Signal Detection & Management
Alexandru Barbarosie, EU/UK QPPV, Global Safety Lead, Amryt Pharma
Oct 917:50
Conference pass

Key performance indicators in a robust global PV system

Compliance
Tsambika Fuchs, Team Lead PV Intelligence and Performance Management, Merck Healthcare KGaA
Oct 917:50
Conference pass

Finding common ground for combination products regarding vigilance

Medical Devices
Ronald Boumans, Independent Medical Devices Expert, EU Medical Devices Expert
Oct 917:50
Conference pass

Management of local PV regulation for global patient safety perspectives

Patient Centricity
Antonella Fretta, Senior Director, Aggregate Reporting Team Lead, Pfizer
Laura Pasetti, Director, Aggregate Reporting Author, Pfizer
Oct 917:50
Conference pass

Turning the ambition into a roadmap to ensure quality, speed, consistency and flexibility

Digital Transformation
Yvonne Schäfer, Head of Patient Safety & Pharmacovigilance Systems Business Solutions, Boehringer Ingelheim International

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Oct 108:55
Conference pass

Chair's Remarks

Keynotes
Shaloo Pandhi, Global Head, Patient Safety, Sandoz
Oct 109:20
Conference pass
Oct 1010:20
Conference pass

Keynote panel discussion

Keynotes
Fatima Bhayat, Chief Safety Officer, Head of Global Patient Safety, Amgen Inc
Karsten Lollike, Corporate Vice President, QPPV, Novo Nordisk
Ercem Atillasoy, Chief Regulatory and Safety Officer, Jazz Pharmaceuticals
Ira Solomon, Chief Safety Officer, Innovation, Johnson & Johnson
Fabian Heisig, Senior Vice President, Head Global Drug Safety & QPPV, Grunenthal
Avinash Kakade, Senior Vice President, Global Head of Pharmacovigilance, Dr. Reddy's Laboratories
Oct 1011:40
Conference pass

Chair's Remarks

Artificial Intelligence
Pav Rishiraj, Director, Head of Patient Safety & ABPI PV Expert Chair, Ipsen & ABPI
Oct 1011:40
Conference pass

Chair's Remarks

Risk Management
Frédérique Delannois, Executive Director, Safety Evaluation & Risk Management Head, Global Safety, GSK
Oct 1011:40
Conference pass

Chair's Remarks

Quality Assurance
Vivienne van de Walle, Medical Director, P.T. and R
Oct 1011:40
Conference pass

Chair's Remarks

Compliance
Daniela Di Cosmo, Senior Safety Advisor, Global Safety, Ferring Pharmaceuticals
Oct 1011:40
Conference pass

Chair's Remarks

Medical Devices
Maritess Esguerra, Senior PV Process Director, Genentech
Oct 1011:40
Conference pass

Chair's Remarks

PV Outsourcing
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
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
Karthick Sukumaran, Director, Technology Enablement, Intelligent Safety Automation, Roche Products Ltd
Oct 1011:45
Conference pass

Differing periodic reports and risk management plans for regulators

Risk Management
Oct 1011:45
Conference pass

The role of AI in global signal detection

Signal Detection & Management
Oct 1011:45
Conference pass

Comparing and contrasting different types of PV audits

Quality Assurance
Ranjana Khanna, Global Director, GVP, QA, R&D Quality, BeiGene
Oct 1011:45
Conference pass

North American pharmacovigilance compliance requirements and inspection readiness

Compliance
Jaylaxmi Nalawade, Director, Pharmacovigilance and REMS, Lupin
Oct 1011:45
Conference pass

Medical safety R&D

Medical Devices
Richard Mayer, Senior Principal Engineer, Head of Medical Safety R&D, Johnson and Johnson
Oct 1011:45
Conference pass

Title TBC

Patient Centricity
Ilaria Grisoni, Executive Director, Head of EU & International Pharmacovigilance, QPPV Office and EEA QPPV, Jazz Pharmaceuticals
Ercem Atillasoy, Chief Regulatory and Safety Officer, Jazz Pharmaceuticals
Oct 1011:45
Conference pass

The patient drug safety paradigm in the 2030's

Digital Transformation
Fabio Lievano, Vice President, Safety Science, AbbVie
Oct 1011:45
Conference pass

Optimising outsourcing across affiliates and regions

PV Outsourcing
Majken Berghuis, Director, Pharmacovigilance, International Operations, Novo Nordisk
Oct 1012:05
Conference pass

Enhancing patient safety through comprehensive risk management plan oversight

Risk Management
Oct 1012:15
Conference pass

Effective management strategies for development safety update reports amid challenges and complexities

Risk Management
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
Achilleas Kalogirou, Lead, Office of Safety Operations, AbbVie
Oct 1012:25
Conference pass

Integrating patient insights into benefit risk assessments

Risk Management
Suzanne Foncin, Senior Director, Head of Safety Analysis and Writing, UCB
Oct 1012:25
Conference pass

Safety management in cell and gene therapies

Signal Detection & Management
Asif Mahmood, Vice President, Medical Safety & Pharmacovigilance, AskBio
Oct 1012:25
Conference pass

The realms of audits and inspections

Quality Assurance
Erika Barbarosie, Associate Director, Compliance, Gilead Sciences
Oct 1012:25
Conference pass

PSMF innovations: using digital tools to build user friendly documents

Compliance
Maria Jose Reneses, Director, Deputy EU QPPV and Head of PSMF, Takeda
Oct 1012:25
Conference pass

New standards for clinical evaluations of medical devices: upcoming ISO standards

Medical Devices
Milos Stojkovic, Safety Process Director, Roche
Oct 1012:25
Conference pass

Monitoring patients in advance therapeutics

Patient Centricity
David Chonzi, Independent Pharma Physician, Independent PV Expert
Oct 1012:25
Conference pass

Open access platform to advance perinatal therapeutics

Digital Transformation
Oct 1012:25
Conference pass

From transition to transformation: improving quality and speed of delivery for patient safety

PV Outsourcing
Justin Joubert, Senior Director, Acquisitions, PV Agreements & Contract Liason, GSK
Oct 1012:45
Conference pass

Sponsor presentation

Quality Assurance
Erika Barbarosie, Associate Director, Compliance, Gilead Sciences
Oct 1013:05
Conference pass

Future innovations with AI: beyond back-end tool

Artificial Intelligence
Rishi Chopra, Executive Director, Global Head of Pharmacovigilance Regions, CSL
Oct 1013:05
Conference pass

Effectiveness of risk minimization measures in Europe

Risk Management
Maha Lakshmi Elluri, Global Safety Director, EEA/UK QPPV, Indivior Pharmaceuticals
Oct 1013:05
Conference pass

Evaluation of adverse events from the Moderna COVID vaccine

Signal Detection & Management
Priyadarshani Dharia, Director, Global Safety Epidemiology, Real World Evidence, Moderna Therapeutics
Oct 1013:05
Conference pass

Inspection in gene therapies: different approaches and experiences

Quality Assurance
Elisabetta Di Martino, Director, GCP, GVP & GLP, Quality Assurance, Orchard Therapeutics
Oct 1013:05
Conference pass

Compliance documentation – does it have to be complicated?

Compliance
Oct 1013:05
Conference pass

Towards a patient-centric shift: reinventing adherence in tuberculosis care

Patient Centricity
Nibedita Rath, Scientific Director, Open Source Pharma Foundation
Oct 1013:05
Conference pass

The promise and challenges of tokenization in clinical trial linkage to real world data

Digital Transformation
Alexander Liede, Senior Director, Global Epidemiology, AbbVie
Oct 1014:25
Conference pass

02 Risk Management Panel – QPPV Oversight for risk management planning and execution

Risk Management
Valentina Mancini, Senior Director, Pharmacovigilance, EU & UK QPPV, Shionogi & TransCelerate
Ilaria Grisoni, Executive Director, Head of EU & International Pharmacovigilance, QPPV Office and EEA QPPV, Jazz Pharmaceuticals
Laura Paola Boga, Senior Director, Head of Global Pharmacovigilance, UK & EU QPPV, Dompé farmaceutici SpA
Margherita D'Antuono, EU-UK QPPV, Piramal Critical Care
Oct 1014:25
Conference pass

03 Signal Detection & Management Panel – Integration of real-world data into signal detection activities

Signal Detection & Management
Akhilesh Chamediya, Global Medical Director, Patient Safety Lead, AstraZeneca & Alexion
Tom Organ, Safety Science Director, Neuroscience TA, Global Patient Safety, Ipsen
Justyna Amelio, Director, Global Epidemiology, AbbVie
Oct 1014:25
Conference pass

04 Quality Assurance Panel – Enhancing cross-departmental collaboration for non-interventional studies

Quality Assurance
Oct 1014:25
Conference pass

05 Compliance Panel – Optimizing PSMFs for inspection findings

Compliance
Jan Cleerbout, Deputy QPPV, Johnson & Johnson Innovative Medicine
Monika Manske, Associate Director, Lead Quality Management and Deputy EEA QPPV, Viatris
Oct 1014:25
Conference pass

07 Risk Management Panel – Continuous professional training for medicine related stakeholders and patients

Medical Devices
Nathan Rivers, Senior Manager, Medical Safety, Jazz Pharmaceuticals
Oct 1014:25
Conference pass

08 Patient Centricity Panel – What is the impact of shared decision making in patient centricity?

Patient Centricity
Ludovic Apoux, Director, Global Lead, Signal Detection, Haleon
Mary Lynne van Poelgeest-Pomfret, President, World Federation for Incontinence and Pelvic Problems (WFIPP)
Mark Daniels, Director, Safety Physician, Jazz Pharmaceuticals
Amit Aggarwal, Executive Director, Medical Affairs & Strategic Partnerships, ABPI
Shaantanu Donde, Senior Medical Director, Head of Portfolio Management Team, Clinical Development & Medical Affairs, Viatris
Oct 1014:25
Conference pass

10 PV Outsourcing Panel – Evolution of outsourcing: highlights and challenges for vendor management

PV Outsourcing
Kathy Roberts, Vice President, Global Phamacovigilance, Incyte Corp.
Oct 1015:25
Conference pass

Advancing AI for PV professionals

Artificial Intelligence
Julia Appelskog, Senior Director, EU QPPV, Global Vaccine Safety, Novavax
Oct 1015:25
Conference pass

Harmonizing local activities to improve PV efficiency

Risk Management
Marjan Dzeparoski, RA and PV Manager, Bionika Pharmaceuticals
Oct 1015:25
Conference pass

Harmonizing local activities to improve PV efficiency

Risk Management
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
Lionel Van Holle, Founder, OpenSourcePV
Oct 1015:25
Conference pass

Local and regional divestment: PV collaboration and quality assurance for database transfers

Quality Assurance
Lynne Comiskey, Divestment Coordination Lead, Sanofi
Oct 1015:25
Conference pass

Fostering end to end collaboration between regulatory and safety organisations for RSI

Compliance
Jenny Griffiths, Senior Principal Associate, Medicines Quality Organisation, Eli Lilly and Company
Oct 1015:25
Conference pass

Sharing is caring – how sharing safety science insights helps affiliate PV teams realize the PV value proposition

Patient Centricity
Vivien Stettner, International PV Operational Excellence Associate Director, AbbVie
Oct 1015:25
Conference pass

MHRA: a digital transformation journey

Digital Transformation
Sarah Vaughan, Head of Vigilance Operations, MHRA
Oct 1016:05
Conference pass

Safety profiling of medicinal products

Risk Management
Tommaso Venturi, Global Pharmacovigilance Risk Evaluation Specialist, ITALFARMACO S.P.A.
Oct 1016:05
Conference pass

Signal management in an immuno-oncology clinical trial

Signal Detection & Management
Ilana Frishman, Senior Director, Pharmacovigilance & Drug Safety, Compugen
Oct 1016:05
Conference pass

The role of drug safety in due diligences

Quality Assurance
Giovanni Furlan, Director, Worldwide Safety Site Lead, Pfizer
Oct 1016:05
Conference pass

Harmonising PSSFs and fulfilling requirements of local agencies

Compliance
Oct 1016:05
Conference pass

Real world evidence within reverse translation

Patient Centricity
Jost Leemhuis, Safety Science Partner and Global Business Lead, Roche
Oct 1016:05
Conference pass

Digital transformation: small steps versus giant leaps

Digital Transformation
Andrew Moore, Director, PV Operations and Compliance, Takeda
Oct 1017:10
Conference pass

Common platforms for education materials in differing geographies

Risk Management
Cristina Hentea, Director, Safety Surveillance and Risk Management, Viatris
Oct 1017:10
Conference pass

Novel methods for signal assessment

Signal Detection & Management
Chris Bone, Pharmacovigilance Scientist, Biogen
Oct 1017:10
Conference pass

PV Down Under: experiences from a TGA inspection

Quality Assurance
Oct 1017:10
Conference pass

First in human: oncology clinical trials - safety considerations

Patient Centricity
Tanuja Halady, Senior Medical Director, Head of Global Patient Safety, Oncology Group III, Merck
Oct 1017:10
Conference pass

Improving mechanistic understanding of adverse events by modelling biological mechanisms

Digital Transformation
Uwe Schühly, Senior Global Program Safety Team Lead, Cell & Gene Therapy, Novartis
Thomas Nirnberger, Chief Executive Officer, Biofi
Oct 1017:50
Conference pass

Contraception in clinical trials

Risk Management
last published: 21/Feb/24 11:25 GMT

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