European Pharmacovigilance Congress 2024
Conference overview
The European Pharmacovigilance Congress, organized by Pharma Education Center, is recognized as one of the most important and appreciated global pharmacovigilance conferences.
EUPV congress is proud to have high quality scientific content as its main characteristic which has attracted growing interest from speakers, sponsors and participants from all over the world.
The EUPV congress gathers PV professionals at all career levels, including key decision makers (e.g. VPs, Executives and Directors,) interested in the always evolving pharmacovigilance world and its new trends, since they are always looking for new ideas to implement more efficient and effective strategies and tools for their departments.
To further improve the value of the congress and continuously make it more and more interesting by bringing new ideas and scientific contents, this year the Scientific Advisory Group has been further widened with the addition of new PV key opinion leaders who need no introduction since their knowledge and skills are world class.
EUPV congress is the forum where all PV stakeholders from all over the world meet and exchange ideas.
ANNUAL EUPV BOOKLET
The 3rd European Pharmacovigilance Congress: speaker abstracts 2019
The 4th European Pharmacovigilance Congress: speaker abstracts 2020
The 5th European Pharmacovigilance Congress: speaker abstracts 2021
The 6th European Pharmacovigilance Congress: speaker abstracts 2022
The 7th European Pharmacovigilance Congress: speaker abstracts 2023
Published by Sage Journals, visit their website here
Congress Format
The European Pharmacovigilance Congress will be a mixed event!
18-19 November | Virtual 9 am- 6 pm
21 November | APERITIF TIME, NH Milano Congress Centre 6 pm – 9 pm
22 November | Face to face, NH Milano Congress Center 9.30 am – 5 pm
APERITIF TIME – November 21 from 6 to 9 pm – NH Milano Congress
Reserve your place to meet and network with your colleagues, experts and opinion leaders!
This year the congress will include:
– 25 Topics
– 11 Virtual & Face-to-Face Parallel Sessions
– 25 Interactives Round Tables
– 2 Face to-Face Workshops
– 2 LECTIO Magistralis
Why attend?
- Learn about the latest Pharmacovigilance trends and updates
- Share experiences and solutions at a leading European event
- Forge new collaborations with key decision makers
- Networking through the virtual platform with Pharma Companies Delegates and Speakers
Who should attend?
- Pharma, Biotech and Medical Devices Industries
- Pharmacovigilance Associations
- Regulatory Bodies
- CROs and CMOs
- Clinical Research Sites
- Data Management Companies
- Software Development Companies
- University Faculties
- PV Consultant Societies
TOPICS 2024
THEMATIC SESSIONS
18/11 – Virtual
– Biological Basis of Adverse Reactions (with focus on SCARs)
– Immunological Adverse Reactions
– Parallel– Comunicating Safety Information in the Digital Era (in progress)
– Signal Detection
– Risk Management
– Parallel – Risk Minimiztion Measures
– LECTIO Magistralis
19/11 – Virtual
– Authorities’ Assessment of PV Reports
– Real Word Data & Real Word Evidence
– Parallel – Evolving Landscape of Electronic Safety data in PV
– Manufacturing & PV Interfaces
– Parallel – Safety in Clinical Trials
– MedDRA (in progress)
– Parallel – Non EU PV Requirements
– LECTIO Magistralis
22/11 – Milan
– Evolving Pharmacovigilance Strategies
– Main Global and Local PV Updates
– F2F Workshop
– Practical Experience of Applying Artificial Intelligence in PV
– Audit & Inspections
and more parallel sessions coming…
November 18th 2024, Virtual
09.00 – Marco Sardella, Chief Pharmacovigilance Officer & EU QPPV | ADIENNE Pharma & Biotech
09.10 – Arduino Mangoni, Strategic Professor in Clinical
Pharmacology | Flinders University, Senior Consultant in Clinical Pharmacology and General Medicine, Adelaide, Australia
09.15 – Chairperson – Giovanni Furlan, Worldwide Safety Site Lead – Thessaloniki (Greece), Safety Risk Lead, Director | Pfizer S.r.l.
09.20 – Severe cutaneous adverse drug reactions: epidemiological and pathophysiological considerations
Arduino Mangoni, Strategic Professor in Clinical Pharmacology | Flinders University, Senior Consultant in Clinical Pharmacology and General Medicine, Adelaide, Australia
09.40 – Understanding the Pathophysiological Mechanisms of SCARS: A Call for Harmonized Definitions and CIOMS Recommendations
Chia-Yu Chu, Prof. Department of Dermatology | National Taiwan University
10.00 – Biological basis of adverse drug reactions affecting the central nervous system
Georgios Papazisis, Professor of Clinical Pharmacology; Medical Director, Clinical Research Unit, School of Medicine | Aristotle University of Thessaloniki, Greece
10.20 – Round Table and Q&A Time
Moderator: G. Furlan
Panelists: A. Mangoni; C. Y. Chu; G. Papazisis
10.50 – Coffee Break & networking
11.10 – Chairperson – Mattia Calissano, Head of Pharmacovigilance | Orchard Therapeutics
11.15 – Assessing the global ,regional and personal immunogenity risk of biologic therapy
Anne de Groot, CEO/CSO and Director | EpiVax
11.35 – Mitigation strategies for immunogenicity of biological therapeutic: Sometimes more is Better
Amy Rosenberg, Senior Director and Consultant, Immunology | EpiVax, Inc
11.55 – Round Table
Moderator: M. Calissano
Panelists: A. De Groot; A. Rosenberg
12.30 – LUNCH
11.10 – Chairperson – Paola Kruger, Head of Expert Patient | EUPATI (Europe an Patient’s Academy for Therapeutic Innovation)
11.20 – Safety Communication aspects of the ConcePTION Mobile App
Amanda Alexe, PV Policy and Liaison Lead, QPPV Office | Novartis
11.40 – Marco Greco, European Patients’ Forum President (EPF) – TBC
12.00 – Panel Discussion
12.30 – LUNCH
1.45 – Chairperson – Maddalena Lino, Safety Risk Lead Director | Pfizer
1.50 – Multi-modal data science for signal detection – What are the Challenges? What are the Opportunities
Natsiavas Pantelis, Researcher (Grade C) | Institute of Applied Biosciences of Centre for Research and Technology Hellas (INAB|CERTH), Thessaloniki, Greece
2.10 – What is the role of Big Data and Artificial Intelligence in Pharmacovigilance?
Gianluca Trifirò | Full Professor of Pharmacology Department of Diagnostics and Public Health | University of Verona
2.30 – Insights into recent safety observations associated with CART cell therapies
Vibha Jawa | Executive Director for Biotherapeutics Bioanalysis in clinical Pharmacology, Pharmacometricsand Bioanalysis (NDB) organization | Bristol Myers Squibb
2.50 – Round Table and Q&A Time:
Moderator: M. Lino
Panelists: V. Jawa, N. Pantelis, G. Trifirò, F. De Gregorio | Shionogi Europe
3.20 – Coffee Break & Networking
Maria Beatrice Panico | Principal Consultant | Scendea
3.40 – Chairperson – Glyn Belcher, CEO | PV Consultancy Ltd.
3.45 – Proposing Benefit-Risk Management Plans as the evolution of RMPs
Robert Massouh, Head of (PV) Risk Management and Benefit Risk Evaluation | Gsk
4.05 – Pregnancy prevention – RMM effectiveness evaluation experience
Klaudija Marijanovic Barac, Sr. Director, EU&UK QPPV Deputy, Head Periodic Reports and Risk Management Unit | TEVA
4.25 – Pharmaceuticals in the environment: from Echopharmacovigilance to neurobehavioral studieson zebrafish
Giovanna Paolone, Associate Professor of Pharmacology – Department of Diagnostics and Public Health | University of Verona
4.45 – Round Table and Q&A Time
Moderator: G. Belcher
Panelists: R. Massouh; K.M. Barac; G. Paolone
3.40 – Chairperson – Hrvoje Macek, VP, Medical & Scientific Affairs, an Patient’s Academy for Therapeutic Innovation
3.45 – Design, implementation, and evaluation of risk minimization measures
Michael Von Forstner, Head of Safety Science | Sobi
4.05 – aRMM in pregnancy risk mitigation
Iva Kuliš, Principal Coordinator for Information in PV and Rational Pharmacotherapy, Dept for PV and Rational Pharmacotherapy| HALMED
4.25 – Challenges of benefit-risk assessment – when to trigger a referral procedure?
Barbara Kovačić Bytyqi, Head of Departement for Pharmacovigilance and Rational Pharmacotherapy | HALMED
4.45 – Round Table and Q&A Time
Moderator: H. Macek
Panelists: B. Kovačić Bytyqi; I. Kuliš; M. Von Forstner
5.15 – Marco Sardella, Chief Pharmacovigilance Officer & EU QPPV | ADIENNE Pharma & Biotech
5.20 – What are the cardiovascular risks of NSAIDs?
Nicholas Moore, Emeritus Professor of Clinical Pharmacology | University of Bordeaux
5.45 – Q&A Time
6.00 – Closure of the Day
November 19th 2024, Virtual
09.00 – Marco Sardella, Chief Pharmacovigilance Officer & EU QPPV | ADIENNE Pharma & Biotech
09.10 – Chairperson – Mircea Ciuca, Global Therapeutic Area Head in Global Clinical Safety and Pharmacovigilance
09.15 – PSUR assessment by The Malta Medicines Authority
John Joseph Borg | Director Post-Licensing | Malta
Medicines Authority
09.35 – Challenges in risk-benefit assessment
Roxana Dondera | Head of Pharmacovigilance and Risk Management Unit | National Agency for Medicine and Medical Devices of Romania
09.55 – Risk Management Plan for Radiopharmaceuticals
Sofia Trantza | Senior Pharmacovigilance Expert | PRAC member Greece
10.15 – Round Table and Q&A Time
Moderator: M. Ciuca
Panelists: J.J. Borg; R. Dondera; S. Trantza
10.45 – Coffee Break & networking
11.05 – Chairperson – Lembit Rago, Secretary-General | Council for International Organizations of Medical Sciences (CIOMS)
11.10 – RWD and RWE in regulatory decision making: CIOMS WG XIII Report
Lembit Rago, Secretary-General |Council for International Organizations of Medical Sciences (CIOMS)
11.30 – From RWD to RWE – Teva experience
Željana Margan Koletić, Senior Manager, Risk Management Plans (RMP) Team Leader | Teva
11.50 – Analysis of the nature and contributory factors of medication safety incidents following Hospital disharge using National Reporting and Learning System (NRLS) data from England and Wales: a multi-method study
Fatema Alqenae, Pharmacist | Kuwait – Winner EUPV 2023 Award
12.10 – Round Table and Q&A Time
Moderator: L. Rago
Panelists: Z.M. Koletic; F. Alqenae
12.30 – LUNCH
11.05 – Chairperson – Jan Petracek, CEO | iVigee
11.10 – Evolving Landscape of electronic safe data in PV in the EU
Calin Lungu | DDCS S.A., CEO
11.40 – TBD
12.00 – Panel Discussion
12.30 – LUNCH
1.45 – Chairperson – Valentina Mancini, Senior Director Pharmacovigilance QPPV | Shionogi Europe
1.50 – Looking for triggers: from the small signal to the bigger picture
AIFA Representative (tbc)
2.10 – NCE Early Development and Manufacturing : Idiosyncratic Reactions Risk Mitigation in Post Marketing
Terenzio Ignoni, SVP Quality and CMC | Gain Therapeutics
2.30 – Impact of Manufacturing Changes on Pharmacovigilance for Biological Products
Dina B. Tresnan, Disease Area Cluster Lead – Immunolo-Oncology; Safety Surveillance and Risk Management, Worldwide Safety | Pfizer
2.50 – Round Table
Moderator: TBC
Panelists: AIFA Representative (tbc); T. Ignoni; D. Tresnan
1.45 – Chairperson – Mircea Ciuca, Global Therapeutic Area Head in Global Clinical Safety and Pharmacovigilance
1.50 – Safety in clinical trials under the clinical trial regulation: state of play and first experience
Elena Prokofyeva, Head of safety in clinical trials unit, DG Post, FAMHP
2.10 – From SUSAR to risk via signal management
Mircea Ciuca | Global Therapeutic Area Head in Global Clinical Safety and Pharmacovigilance
2.30/3 – Q&A Time
3.20 – Coffee Break
3.40 – Chairperson – Marco Sardella, Chief Pharmacovigilance Officer & EU QPPV | ADIENNE Pharma & Biotech
3.45 – Adverse Event Grouping Strategies During Clinical Trial Analysis
Scott Proestel | VP, Medical Informatics | Medpace, Inc., former Senior Medical Officer | FDA
4.05 – Aoibhinn McDonnell | Safety Risk Lead, Director, Safety Surveillance and Risk Management | Pfizer
4.25 – Round Table
Moderator: M. Sardella
Panelists: S. Proestel; A. McDonnell
3.40 – Chairperson – Mattia Calissano, Head of Pharmacovigilance | Orchard Therapeutics
3.45 – UK Pharmacovigilance Requirements: A Regulator’s Perspective
Fazil Afzal, Medical Assessor at Medicines and Healthcare products Regulatory Agency (tbc)
4.05 – Elevating Pharmacovigilance in Saudi Arabia beyond Benchmarks to Innovation
Mayssa Abou Ghannam, Country Safety Team Lead, Saudi Arabia, Gulf, Pakistan, Afghanistan | Johnson & Johnson
4.25 – Comparison of RMM Approaches across EU, Japan and US
Robert Massouh, Head of (PV) Risk Management and Benefit Risk Evaluation | Gsk
4.45 – Regulatory Requirements of Pharmacovigilance in India
Geeta Shanbhag, VP Pharmacovigilance and MedicoRegulatory Affairs | Ipca Laboratories Ltd.
5.05 – Round Table
Moderator: M. Calissano
Panelists: F. Afzal; M. AbouGhannam; R. Massouh; G. Shanbhag
5.30 – Marco Sardella, Chief Pharmacovigilance Officer & EU QPPV | ADIENNE Pharma & Biotech
5.30 – Pharmacovigilance – Where have we come from and where are we going?
Glyn Belcher | Senior Scientific Advisor | EUPV Congress
6.00 Closure of the Day
November 22nd, Face-to-Face in Milan
09.20 – Marco Sardella, Chief Pharmacovigilance Officer & EU QPPV | ADIENNE Pharma & Biotech
9.30 – Chairperson – Giovanni Furlan, Worldwide Safety Site Lead – Thessaloniki (Greece), Safety Risk Lead, Director | Pfizer S.r.l.
Panel Discussion:
Felix Arellano, Senior Vice President and the Global Head of Safety & Risk Management | Roche
Andrew Bate, VP Safety Innovation & Analytics | GSK
Marcin Kruk, Drug Safety Regional Head Europe , Africa, Middle East, Worlwide Medical & Safety | Pfizer Inc.
Sofia Trantza, Senior Pharmacovigilance Expert | PRAC Member Greece
10.40 – Coffee Break
11.10 – Chairperson – Calin Lungu, CEO | DDCS S.A.
11.15 – ICH E6 (R3)
AIFA Representative (tbc)
11.35 – Global and Local PV Regulatory Intelligence with AI: New Collection, Assessment, and Interpretation
Marcela Fialova, Chief Operating Officer | iVigee
11.55 – Global and Local PV requirements – Establishing and maintaining a compliant global PV system
Ilaria Grisoni, Exec. Dir., Head of EU/International PV & Office of QPPV, EEA QPPV | Jazz Pharmaceuticals
12.15 – Round Table
Moderator: C. Lungu
Panelists: AIFA Representative; I. Grisoni; M. Fialova; D. Marcozzi | Fidiapharma
12.40 – Award Ceremony for the selected PV article published in Therapeutic Advanced in Drug Safety 2023
12.50 – Lunch & Networking
INTERACTIVE WORKSHOP
Topic 1
The Latest revisions of GVP guidelines on Risk Minimisation Measures and Definition – let’s navigate together through the updates
Mercedina del Papa, Strategic Advisor, EU QPPV | Prime Vigilance
Topic 2
Pharmacovigilance between MA application and approval – challenges for sponsors transforming to MAH
Natalia Kalousova Kocankova, Senior Strategic Advisor, EU QPPV Office Director | PrimeVigilance
2.00 – Chairperson – Andrew Bate, VP Safety Innovation & Analytics | GSK
2.05 – MHRA experience in applications for AI in Pharmacovigilance
Phil Tregunno, Deputy Director, Patient Safety Monitoring, Safety and Surveillance | MHRA
2.25 – Revolutionize Signal management with AI
Maurizio Sessa, Associate Professor of Pharmacoepidemiology | University of Copenhagen
2.45 – AI in Pharmacovigilance at the Swedish Medical products Agency
Gabriel Westman, Head of Artificial Intelligence | Swedish Medical Products Agency
3.05 – Round Table
Moderator: A. Bate
Panelists: P. Tregunno; M. Sessa; V. Mancini | Shionogi Europe
3.30 – Coffee Break
4.00 – Chairperson – Gian Nicola Castiglione, Pharmacovigilance Senior Consultant, Member and Secretary of SIMeF, ETS Board, Master of Labor. Past Head of Global Pharmacovigilance and EU-UK QPPV | Chiesi Farmaceutici S.p.A.
4.05 – AIFA Representative (tbc)
4.25 – Aurora María Rojo Sanchís, Head of GCP and GVP Inspectorate Spanish Agency of Medicines and Medical Devices (AEMPS)
4.45 – Iva Novak, Head of European Pharmacovigilance and EU QPPV | Teva
5.05 – Round Table
Moderator: G.N. Catiglione
Panelists: AIFA Representative; M. D’Antuono | Piramal , I. Novak; A.M. Rojo Sanchís
5.30 – Closure of the Congress
Scientific Advisory Group 2024 – In Progress…
Andrew Bate
VP, Head of Safety Innovation & Analytics | GSK
Glyn Belcher
Senior Scientific Advisor | EU PV
Congress
Mattia Calissano
Head of Pharmacovigilance | Orchard Therapeutics
Gian Nicola Castiglione
Pharmacovigilance Senior Consultant, Member and Secretary of SIMeF, ETS Board, Master of Labor. Past Head of Global Pharmacovigilance and EU-UK QPPV | Chiesi Farmaceutici S.p.A.
Mircea Ciuca
Global Therapeutic Area Head in Global Clinical Safety and Pharmacovigilance
Giovanni Furlan
Worldwide Safety Site Lead – Thessaloniki (Greece), Safety Risk Lead, Director | Pfizer S.r.l.
Calin A. Lungu
DDCS S.A., CEO
Hrvoje Maček
VP, Medical & Scientific Affairs, EU QPPV | PrimeVigilance
Valentina Mancini
Senior Director Pharmacovigilance, QPPV | Shionogi Europe
Jan Petracek
CEO | iVigee
Director, Institute of Pharmacovigilance
Marco Sardella
Chief Pharmacovigilance Officer & EU-UK QPPV| ADIENNE Pharma & Biotech
Speakers 2024 – In Progress…
John -Joseph Borg
Director Post-Licensing | Malta Medicines Authority
Roxana Dondera
Head of Pharmacovigilance and Risk Management Unit | National Agency for Medicine and Medical Devices of Romania
Fazil Afzal
Medical Assessor | Medicines and Healthcare products Regulatory Agency (MHRA)
Felix Arellano
Senior Vice President and the Global Head of Safety & Risk Management | Roche
Phil Tregunno
Deputy Director, Patient Safety Monitoring, Safety and Surveillance | MHR
Scott Proestel
VP, Medical Informatics |Medpace,Inc., former Senior Medical Officer | FDA (tbc)
Glyn Belcher
Senior Scientific Advisor | EU PV Congress
Lembit Rägo
Secretary-General | Council for International Organizations of Medical Sciences (CIOMS)
Sofia Trantza
Senior Pharmacovigilance Expert , PRAC member Greece
Calin A. Lungu
DDCS S.A., CEO
Terenzio Ignoni
SVP Quality and CMC | Gain Therapeutics
Arduino Mangoni
Strategic Professor in Clinical Pharmacology | Flinders University; Senior Consultant in Clinical Pharmacology and General Medicine, Adelaide, Australia
Andrew Bate
VP Safety Innovation & Analytics | GSK
Gabriel Westman
Head of Artificial Intelligence | Swedish Medical Products Agency
Anne De Groot
CEO/CSO and Director | Epivax
Robert Massouh
Head of (PV) Risk Management and Benefit Risk Evaluation | Gsk
Nicholas Moore
Emeritus Professor of Clinical Pharmacology | University of Bordeaux
Chia Yu Chu
Prof. Department of Dermatology | National Taiwan University
Georgios Papazisis
Professor of Clinical Pharmacology; Medical Director, Clinical Research Unit | School of Medicine, Aristotle University of Thessaloniki
Fabio De Gregorio
Vice President, Head of Drug Safety Europe | Shionogi Europe
Mayssa AbouGhannam
Country Safety Team Lead, Saudi Arabia, Gulf, Pakistan, Afghanistan | Johnson & Johnson
Marcin Kruk
Drug Safety Regional Head Europe , Africa, Middle East, Worlwide Medical & Safety |Pfizer Inc.
Elena Prokofyeva
Head of safety in clinical trials unit, DG Post, FAMHP
Amalia Alexe
PV Policy and Liaison Lead, QPPV Office | Novartis
Amy Rosemberg
Senior Director and Consultant, Immunology | EpiVax, Inc
Maurizio Sessa
Associate Professor of Pharmacoepidemiology | University of Copenhagen
Geeta Shanbhag
VP Pharmacovigilance and Medico-Regulatory Affairs | Ipca Laboratories Ltd
Giovanna Paolone
Associate Professor of Pharmacology – Department of Diagnostics and Public Health | University of Verona
Alqenae Fatema
Pharmacist | University of Manchester –
Winner EUPV 2024 Award
Dina B. Tresnan
Disease Area Cluster Lead -Immunolo-Oncology; Safety
Surveillance and Risk Management, Worldwide Safety | Pfizer
Ilaria Grisoni
Executive Director, Head of EU/International PV & Office of QPPV, EEA QPPV | Jazz Pharmaceuticals
Vibha Jawa
Executive Director | Bristol Myers Squibb
Klaudija Marijanovic Barac
Sr. Director, EU&UK QPPV Deputy, Head Periodic Reports and Risk Management Centre | TEVA
Zeljana Margan Koletic
Senior Manager, Risk Management Plans (RMP) Team Leader | Teva
Iva Novak
Head of European Pharmacovigilance and EU QPPV | Teva
Marcela Fialova
Chief Operating Officer | iVigee
Margherita D’Antuono
EU-UK QPPV| Piramal Critical Care
Aurora María Rojo Sanchís
Head of GCP and GVP Inspectorate Spanish Agency of Medicines and Medical Devices (AEMPS)
Marco Greco
European Patients’ Forum President (EPF)
Maddalena Lino
Safety Risk Lead Director | Pfizer
Daniela Marcozzi
Head of Corporate Clinical Safety, Pharmacovigilance and R&D Compliance QP for Pharmacovigilance EU & UK, Graduated Plan Officer AMG 63a
Company Representative for Competent Health Authorities
Barbara Kovačić Bytyqi
Head of Department for Pharmacovigilance and Rational Pharmacotherapy | HALMED
Paola Kruger
Expert Patient | EUPATI (European Patient’s Academy for Therapeutic Innovation)
Iva Kuliš
Principal Coordinator for Information in PV and Rational Pharmacotherapy, Dept for PV and Rational Pharmacotherapy | HALMED
Michael Von Forstner
Head of Safety Science| Sobi
Aoibhinn McDonnell
Safety Risk Lead, Director, Safety Surveillance and Risk Management | Pfizer
Natalia Kalousova Kocankova
Senior Strategic Advisor, EU QPPV Office Director | PrimeVigilance
Mercedina del Papa
Strategic Advisor, EU QPPV | Prime Vigilance
Sponsors & Media Partners 2024 – In Progress…
Baupharma
Silver Sponsor
Baupharma
Silver Sponsor
Baupharma, headquartered in Prague, is a premier pharmaceutical service provider with over 25 years of industry experience. Our international team offers comprehensive services—including pharmacovigilance, regulatory affairs, medical writing, batch release and distribution, translations, and clinical research—across the EU, MENA region, CIS, Africa, USA, LATAM, and beyond. With offices in Czech Republic, Saudi Arabia, UAE and Egypt, we ensure efficient project management and collaboration, delivering tailored solutions that meet the unique needs of each market.
Visit our website »
Insuvia
Bronze Sponsor
Insuvia
Bronze Sponsor
Insuvia is designed to act as a pharmacovigilance unit for pharmaceutical companies in those countries and regions, where they have no internal structures or decide to focus their resources on commercial activities. In this context, we provide the regional EU and country-level expertise to solve all pharmacovigilance challenges that pharmaceutical companies encounter while commercializing their products.
Visit our website »
iVigee
Gold Plus Sponsor
iVigee
Gold Plus Sponsor
iVigee is a leading pharmacovigilance services and technology company focused on creating simple, powerful, and elegant drug safety solutions that span the entire drug safety life cycle.
We combine years of experience with the latest innovative AI technologies to create the ‘instant pharmacovigilance department’, deployable anywhere, on-demand.
Our teams support clients around the world with progressive pharmacovigilance and data management requirements from our strategic bases in Central Europe and the US East Coast.
iVigee: Simple. Powerful. Elegant.
Visit our website »
Pharma D&S
Exhibitor
Pharma D&S
Exhibitor
Pharma D&S is an European Service Provider active in Lifescience field with a panel of more than 180 consultants who provide and support pharmaceutical companies in Pharmacovigilance, Clinical Research, Regulatory Affairs and Quality needs. We are partner whit over 400 companies by managing different areas of the product’s entire lifecycle and our customers can find a range of services and a multidisciplinary activities. We believe in the Relationship and client’s Loyalty, in understanding and sharing their goals, integrating with their staff and processes. We trust People, fostering their growth and promoting their commitment. We believe in Innovation and Creativity, in seeking constantly new approaches, ideas and solutions.
Visit our website »
Accuvigil Private Limited
Sponsor
Accuvigil Private Limited
Sponsor
Accuvigil is a dynamic newcomer in the world of pharmacovigilance, with its revolutionary approach and unparalleled commitment to drug safety and regulatory excellence. Our seasoned pharmacovigilance experts bring 30 years of combined experience to ensure the safety and efficacy of your products throughout their lifecycle. We offer comprehensive end-to-end pharmacovigilance solutions, making us the ideal partner for PV outsourcing for companies with or without established PV infrastructure. We provide top-notch services at competitive prices by harnessing the latest knowledge and state-of-the-art software from our strategic SAAS partnerships. Choose Accuvigil for proactive and dependable pharmacovigilance support, safeguarding both your brand and public health.
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PrimeVigilance
Gold Sponsor
PrimeVigilance
Gold Sponsor
PrimeVigilance, an Ergomed company, has grown to become the leading Pharmacovigilance specialist company, delivering global solutions for clinical safety and post-marketing pharmacovigilance and medical information from our operational hubs based in Europe, the USA, and Japan.
Our extensive experience enables us to offer a comprehensive, top-quality, cost-effective, and innovative safety solution. Our flexible approach, tailor-made to work with clients, allows us to deliver the services that meet your clinical and post-marketing needs.
PrimeVigilance provides pharmacovigilance solutions to over 200 clients who distribute their products worldwide. PrimeVigilance manages a global Pharmacovigilance system with a choice of leading drug safety databases stretching to more than 100 countries.
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Sage
Media Partner
Sage
Media Partner
Published by SAGE, Therapeutic Advances in Drug Safety (Impact Factor: 4.4) is an international peer-reviewed Open Access journal, delivering the highest quality original research articles, reviews, and scholarly comment on pioneering efforts and innovative studies pertaining to the safe use of drugs in patients. The journal has a strong clinical and pharmacological focus and is aimed at an international audience of clinicians and researchers in drug safety, providing an online forum for rapid dissemination of recent research and perspectives in this area.
As the official Media Partner of the 6th edition of the European Pharmacovigilance Congress, Therapeutic Advances in Drug Safety will be publishing an online abstract supplement which will be free to access online.
For more information:
E-mail: jonathan.collin@sagepub.co.uk
Twitter: @TADrugSafety
Visit our website »
Max Application
Exhibitor
Max Application
Exhibitor
Max Application is an IT company specialized in software solutions and focused on continuity, competence and passion in service.
Oracle partner for over 20 years, it offers cloud and on-premise solutions for sectors such as textile manufacturing, automotive and in mainly healthcare. The flagship of the latter is SafetyDrugs, the leading safety database for pharmacovigilance in Italy, accompanied by the Business Intelligence module, essential for Signal Detection.
Always committed to innovation, now part of Abacus Group, it benefits from the synergies and opportunities offered by this strategic partnership in areas such as IT infrastructure, cybersecurity, system integration and artificial intelligence.
Visit our website »
Become a sponsor
The European Pharmacovigilance Congress provides an excellent opportunity to get in touch with PV professionals and decision makers through a powerful virtual exhibition area. To sponsor the event, contact us.
Conference Venue
Step 1
On November 18-19 the event will be VIRTUAL to grant you the possibility of joining the conference even from your office or home, wherever you may be. We have organized a true virtual location, a space where you will be able to:
- Follow the live streaming of the congress, listen to experts and opinion makers and be informed about latest trends and technological breakthroughs in drug safety
- Visit the VIRTUAL EXHIBITION AREA and all the stands of our sponsors
- Join Q&A times and round tables to discuss the current hot topics in the field
- Chat with our sponsors and learn about new technologies and services to ease your daily work and increase the performance
Step 2
Let’s finally meet face to face in Milan on November 22! A great chance to meet in person the EUPV experts and colleagues. A great chance to meet in person the EUPV experts and colleagues. The conference will be hosted in the wonderful spaces of NH Milano Congress Centre, in Assago, Milan.
By plane
From Malpensa Airport:
-
- take the bus to the central station, then the subway towards Assago Milanofiori Forum
- take the express train from Malpensa to the Cadorna station, then the Green subway in the direction of Assago Milanofiori Forum.
From Linate Airport:
take the bus to San Babila station, then the subway towards Assago Milanofiori Forum.
By train
From Centrale or Cadorna train station, take green line subway to Assago Milanofiori Forum.
By tram
From Piazza del Duomo:
take the red subway line towards RHO FIERAMILANO and change at CADORNA. Take the green line towards ASSAGO MILANOFIORI FORUM and get off at the Assago Milanofiori Forum stop. Walk for about 7 minutes to reach the hotel.
Conference overview
The European Pharmacovigilance Congress, organized by Pharma Education Center, is recognized as one of the most important and appreciated global pharmacovigilance conferences.
EUPV congress is proud to have high quality scientific content as its main characteristic which has attracted growing interest from speakers, sponsors and participants from all over the world.
The EUPV congress gathers PV professionals at all career levels, including key decision makers (e.g. VPs, Executives and Directors,) interested in the always evolving pharmacovigilance world and its new trends, since they are always looking for new ideas to implement more efficient and effective strategies and tools for their departments.
To further improve the value of the congress and continuously make it more and more interesting by bringing new ideas and scientific contents, this year the Scientific Advisory Group has been further widened with the addition of new PV key opinion leaders who need no introduction since their knowledge and skills are world class.
EUPV congress is the forum where all PV stakeholders from all over the world meet and exchange ideas.
ANNUAL EUPV BOOKLET
The 3rd European Pharmacovigilance Congress: speaker abstracts 2019
The 4th European Pharmacovigilance Congress: speaker abstracts 2020
The 5th European Pharmacovigilance Congress: speaker abstracts 2021
The 6th European Pharmacovigilance Congress: speaker abstracts 2022
The 7th European Pharmacovigilance Congress: speaker abstracts 2023
Published by Sage Journals, visit their website here
Congress Format
The European Pharmacovigilance Congress will be a mixed event!
18-19 November | Virtual 9 am- 6 pm
21 November | APERITIF TIME, NH Milano Congress Centre 6 pm – 9 pm
22 November | Face to face, NH Milano Congress Center 9.30 am – 5 pm
APERITIF TIME – November 21 from 6 to 9 pm – NH Milano Congress
Reserve your place to meet and network with your colleagues, experts and opinion leaders!
This year the congress will include:
– 25 Topics
– 11 Virtual & Face-to-Face Parallel Sessions
– 25 Interactives Round Tables
– 2 Face to-Face Workshops
– 2 LECTIO Magistralis
Why attend?
- Learn about the latest Pharmacovigilance trends and updates
- Share experiences and solutions at a leading European event
- Forge new collaborations with key decision makers
- Networking through the virtual platform with Pharma Companies Delegates and Speakers
Who should attend?
- Pharma, Biotech and Medical Devices Industries
- Pharmacovigilance Associations
- Regulatory Bodies
- CROs and CMOs
- Clinical Research Sites
- Data Management Companies
- Software Development Companies
- University Faculties
- PV Consultant Societies
TOPICS 2024
THEMATIC SESSIONS
18/11 – Virtual
– Biological Basis of Adverse Reactions (with focus on SCARs)
– Immunological Adverse Reactions
– Parallel– Comunicating Safety Information in the Digital Era (in progress)
– Signal Detection
– Risk Management
– Parallel – Risk Minimiztion Measures
– LECTIO Magistralis
19/11 – Virtual
– Authorities’ Assessment of PV Reports
– Real Word Data & Real Word Evidence
– Parallel – Evolving Landscape of Electronic Safety data in PV
– Manufacturing & PV Interfaces
– Parallel – Safety in Clinical Trials
– MedDRA (in progress)
– Parallel – Non EU PV Requirements
– LECTIO Magistralis
22/11 – Milan
– Evolving Pharmacovigilance Strategies
– Main Global and Local PV Updates
– F2F Workshop
– Practical Experience of Applying Artificial Intelligence in PV
– Audit & Inspections
and more parallel sessions coming…
November 18th 2024, Virtual
09.00 – Marco Sardella, Chief Pharmacovigilance Officer & EU QPPV | ADIENNE Pharma & Biotech
09.10 – Arduino Mangoni, Strategic Professor in Clinical
Pharmacology | Flinders University, Senior Consultant in Clinical Pharmacology and General Medicine, Adelaide, Australia
09.15 – Chairperson – Giovanni Furlan, Worldwide Safety Site Lead – Thessaloniki (Greece), Safety Risk Lead, Director | Pfizer S.r.l.
09.20 – Severe cutaneous adverse drug reactions: epidemiological and pathophysiological considerations
Arduino Mangoni, Strategic Professor in Clinical Pharmacology | Flinders University, Senior Consultant in Clinical Pharmacology and General Medicine, Adelaide, Australia
09.40 – Understanding the Pathophysiological Mechanisms of SCARS: A Call for Harmonized Definitions and CIOMS Recommendations
Chia-Yu Chu, Prof. Department of Dermatology | National Taiwan University
10.00 – Biological basis of adverse drug reactions affecting the central nervous system
Georgios Papazisis, Professor of Clinical Pharmacology; Medical Director, Clinical Research Unit, School of Medicine | Aristotle University of Thessaloniki, Greece
10.20 – Round Table and Q&A Time
Moderator: G. Furlan
Panelists: A. Mangoni; C. Y. Chu; G. Papazisis
10.50 – Coffee Break & networking
11.10 – Chairperson – Mattia Calissano, Head of Pharmacovigilance | Orchard Therapeutics
11.15 – Assessing the global ,regional and personal immunogenity risk of biologic therapy
Anne de Groot, CEO/CSO and Director | EpiVax
11.35 – Mitigation strategies for immunogenicity of biological therapeutic: Sometimes more is Better
Amy Rosenberg, Senior Director and Consultant, Immunology | EpiVax, Inc
11.55 – Round Table
Moderator: M. Calissano
Panelists: A. De Groot; A. Rosenberg
12.30 – LUNCH
11.10 – Chairperson – Paola Kruger, Head of Expert Patient | EUPATI (Europe an Patient’s Academy for Therapeutic Innovation)
11.20 – Safety Communication aspects of the ConcePTION Mobile App
Amanda Alexe, PV Policy and Liaison Lead, QPPV Office | Novartis
11.40 – Marco Greco, European Patients’ Forum President (EPF) – TBC
12.00 – Panel Discussion
12.30 – LUNCH
1.45 – Chairperson – Maddalena Lino, Safety Risk Lead Director | Pfizer
1.50 – Multi-modal data science for signal detection – What are the Challenges? What are the Opportunities
Natsiavas Pantelis, Researcher (Grade C) | Institute of Applied Biosciences of Centre for Research and Technology Hellas (INAB|CERTH), Thessaloniki, Greece
2.10 – What is the role of Big Data and Artificial Intelligence in Pharmacovigilance?
Gianluca Trifirò | Full Professor of Pharmacology Department of Diagnostics and Public Health | University of Verona
2.30 – Insights into recent safety observations associated with CART cell therapies
Vibha Jawa | Executive Director for Biotherapeutics Bioanalysis in clinical Pharmacology, Pharmacometricsand Bioanalysis (NDB) organization | Bristol Myers Squibb
2.50 – Round Table and Q&A Time:
Moderator: M. Lino
Panelists: V. Jawa, N. Pantelis, G. Trifirò, F. De Gregorio | Shionogi Europe
3.20 – Coffee Break & Networking
Maria Beatrice Panico | Principal Consultant | Scendea
3.40 – Chairperson – Glyn Belcher, CEO | PV Consultancy Ltd.
3.45 – Proposing Benefit-Risk Management Plans as the evolution of RMPs
Robert Massouh, Head of (PV) Risk Management and Benefit Risk Evaluation | Gsk
4.05 – Pregnancy prevention – RMM effectiveness evaluation experience
Klaudija Marijanovic Barac, Sr. Director, EU&UK QPPV Deputy, Head Periodic Reports and Risk Management Unit | TEVA
4.25 – Pharmaceuticals in the environment: from Echopharmacovigilance to neurobehavioral studieson zebrafish
Giovanna Paolone, Associate Professor of Pharmacology – Department of Diagnostics and Public Health | University of Verona
4.45 – Round Table and Q&A Time
Moderator: G. Belcher
Panelists: R. Massouh; K.M. Barac; G. Paolone
3.40 – Chairperson – Hrvoje Macek, VP, Medical & Scientific Affairs, an Patient’s Academy for Therapeutic Innovation
3.45 – Design, implementation, and evaluation of risk minimization measures
Michael Von Forstner, Head of Safety Science | Sobi
4.05 – aRMM in pregnancy risk mitigation
Iva Kuliš, Principal Coordinator for Information in PV and Rational Pharmacotherapy, Dept for PV and Rational Pharmacotherapy| HALMED
4.25 – Challenges of benefit-risk assessment – when to trigger a referral procedure?
Barbara Kovačić Bytyqi, Head of Departement for Pharmacovigilance and Rational Pharmacotherapy | HALMED
4.45 – Round Table and Q&A Time
Moderator: H. Macek
Panelists: B. Kovačić Bytyqi; I. Kuliš; M. Von Forstner
5.15 – Marco Sardella, Chief Pharmacovigilance Officer & EU QPPV | ADIENNE Pharma & Biotech
5.20 – What are the cardiovascular risks of NSAIDs?
Nicholas Moore, Emeritus Professor of Clinical Pharmacology | University of Bordeaux
5.45 – Q&A Time
6.00 – Closure of the Day
November 19th 2024, Virtual
09.00 – Marco Sardella, Chief Pharmacovigilance Officer & EU QPPV | ADIENNE Pharma & Biotech
09.10 – Chairperson – Mircea Ciuca, Global Therapeutic Area Head in Global Clinical Safety and Pharmacovigilance
09.15 – PSUR assessment by The Malta Medicines Authority
John Joseph Borg | Director Post-Licensing | Malta
Medicines Authority
09.35 – Challenges in risk-benefit assessment
Roxana Dondera | Head of Pharmacovigilance and Risk Management Unit | National Agency for Medicine and Medical Devices of Romania
09.55 – Risk Management Plan for Radiopharmaceuticals
Sofia Trantza | Senior Pharmacovigilance Expert | PRAC member Greece
10.15 – Round Table and Q&A Time
Moderator: M. Ciuca
Panelists: J.J. Borg; R. Dondera; S. Trantza
10.45 – Coffee Break & networking
11.05 – Chairperson – Lembit Rago, Secretary-General | Council for International Organizations of Medical Sciences (CIOMS)
11.10 – RWD and RWE in regulatory decision making: CIOMS WG XIII Report
Lembit Rago, Secretary-General |Council for International Organizations of Medical Sciences (CIOMS)
11.30 – From RWD to RWE – Teva experience
Željana Margan Koletić, Senior Manager, Risk Management Plans (RMP) Team Leader | Teva
11.50 – Analysis of the nature and contributory factors of medication safety incidents following Hospital disharge using National Reporting and Learning System (NRLS) data from England and Wales: a multi-method study
Fatema Alqenae, Pharmacist | Kuwait – Winner EUPV 2023 Award
12.10 – Round Table and Q&A Time
Moderator: L. Rago
Panelists: Z.M. Koletic; F. Alqenae
12.30 – LUNCH
11.05 – Chairperson – Jan Petracek, CEO | iVigee
11.10 – Evolving Landscape of electronic safe data in PV in the EU
Calin Lungu | DDCS S.A., CEO
11.40 – TBD
12.00 – Panel Discussion
12.30 – LUNCH
1.45 – Chairperson – Valentina Mancini, Senior Director Pharmacovigilance QPPV | Shionogi Europe
1.50 – Looking for triggers: from the small signal to the bigger picture
AIFA Representative (tbc)
2.10 – NCE Early Development and Manufacturing : Idiosyncratic Reactions Risk Mitigation in Post Marketing
Terenzio Ignoni, SVP Quality and CMC | Gain Therapeutics
2.30 – Impact of Manufacturing Changes on Pharmacovigilance for Biological Products
Dina B. Tresnan, Disease Area Cluster Lead – Immunolo-Oncology; Safety Surveillance and Risk Management, Worldwide Safety | Pfizer
2.50 – Round Table
Moderator: TBC
Panelists: AIFA Representative (tbc); T. Ignoni; D. Tresnan
1.45 – Chairperson – Mircea Ciuca, Global Therapeutic Area Head in Global Clinical Safety and Pharmacovigilance
1.50 – Safety in clinical trials under the clinical trial regulation: state of play and first experience
Elena Prokofyeva, Head of safety in clinical trials unit, DG Post, FAMHP
2.10 – From SUSAR to risk via signal management
Mircea Ciuca | Global Therapeutic Area Head in Global Clinical Safety and Pharmacovigilance
2.30/3 – Q&A Time
3.20 – Coffee Break
3.40 – Chairperson – Marco Sardella, Chief Pharmacovigilance Officer & EU QPPV | ADIENNE Pharma & Biotech
3.45 – Adverse Event Grouping Strategies During Clinical Trial Analysis
Scott Proestel | VP, Medical Informatics | Medpace, Inc., former Senior Medical Officer | FDA
4.05 – Aoibhinn McDonnell | Safety Risk Lead, Director, Safety Surveillance and Risk Management | Pfizer
4.25 – Round Table
Moderator: M. Sardella
Panelists: S. Proestel; A. McDonnell
3.40 – Chairperson – Mattia Calissano, Head of Pharmacovigilance | Orchard Therapeutics
3.45 – UK Pharmacovigilance Requirements: A Regulator’s Perspective
Fazil Afzal, Medical Assessor at Medicines and Healthcare products Regulatory Agency (tbc)
4.05 – Elevating Pharmacovigilance in Saudi Arabia beyond Benchmarks to Innovation
Mayssa Abou Ghannam, Country Safety Team Lead, Saudi Arabia, Gulf, Pakistan, Afghanistan | Johnson & Johnson
4.25 – Comparison of RMM Approaches across EU, Japan and US
Robert Massouh, Head of (PV) Risk Management and Benefit Risk Evaluation | Gsk
4.45 – Regulatory Requirements of Pharmacovigilance in India
Geeta Shanbhag, VP Pharmacovigilance and MedicoRegulatory Affairs | Ipca Laboratories Ltd.
5.05 – Round Table
Moderator: M. Calissano
Panelists: F. Afzal; M. AbouGhannam; R. Massouh; G. Shanbhag
5.30 – Marco Sardella, Chief Pharmacovigilance Officer & EU QPPV | ADIENNE Pharma & Biotech
5.30 – Pharmacovigilance – Where have we come from and where are we going?
Glyn Belcher | Senior Scientific Advisor | EUPV Congress
6.00 Closure of the Day
November 22nd, Face-to-Face in Milan
09.20 – Marco Sardella, Chief Pharmacovigilance Officer & EU QPPV | ADIENNE Pharma & Biotech
9.30 – Chairperson – Giovanni Furlan, Worldwide Safety Site Lead – Thessaloniki (Greece), Safety Risk Lead, Director | Pfizer S.r.l.
Panel Discussion:
Felix Arellano, Senior Vice President and the Global Head of Safety & Risk Management | Roche
Andrew Bate, VP Safety Innovation & Analytics | GSK
Marcin Kruk, Drug Safety Regional Head Europe , Africa, Middle East, Worlwide Medical & Safety | Pfizer Inc.
Sofia Trantza, Senior Pharmacovigilance Expert | PRAC Member Greece
10.40 – Coffee Break
11.10 – Chairperson – Calin Lungu, CEO | DDCS S.A.
11.15 – ICH E6 (R3)
AIFA Representative (tbc)
11.35 – Global and Local PV Regulatory Intelligence with AI: New Collection, Assessment, and Interpretation
Marcela Fialova, Chief Operating Officer | iVigee
11.55 – Global and Local PV requirements – Establishing and maintaining a compliant global PV system
Ilaria Grisoni, Exec. Dir., Head of EU/International PV & Office of QPPV, EEA QPPV | Jazz Pharmaceuticals
12.15 – Round Table
Moderator: C. Lungu
Panelists: AIFA Representative; I. Grisoni; M. Fialova; D. Marcozzi | Fidiapharma
12.40 – Award Ceremony for the selected PV article published in Therapeutic Advanced in Drug Safety 2023
12.50 – Lunch & Networking
INTERACTIVE WORKSHOP
Topic 1
The Latest revisions of GVP guidelines on Risk Minimisation Measures and Definition – let’s navigate together through the updates
Mercedina del Papa, Strategic Advisor, EU QPPV | Prime Vigilance
Topic 2
Pharmacovigilance between MA application and approval – challenges for sponsors transforming to MAH
Natalia Kalousova Kocankova, Senior Strategic Advisor, EU QPPV Office Director | PrimeVigilance
2.00 – Chairperson – Andrew Bate, VP Safety Innovation & Analytics | GSK
2.05 – MHRA experience in applications for AI in Pharmacovigilance
Phil Tregunno, Deputy Director, Patient Safety Monitoring, Safety and Surveillance | MHRA
2.25 – Revolutionize Signal management with AI
Maurizio Sessa, Associate Professor of Pharmacoepidemiology | University of Copenhagen
2.45 – AI in Pharmacovigilance at the Swedish Medical products Agency
Gabriel Westman, Head of Artificial Intelligence | Swedish Medical Products Agency
3.05 – Round Table
Moderator: A. Bate
Panelists: P. Tregunno; M. Sessa; V. Mancini | Shionogi Europe
3.30 – Coffee Break
4.00 – Chairperson – Gian Nicola Castiglione, Pharmacovigilance Senior Consultant, Member and Secretary of SIMeF, ETS Board, Master of Labor. Past Head of Global Pharmacovigilance and EU-UK QPPV | Chiesi Farmaceutici S.p.A.
4.05 – AIFA Representative (tbc)
4.25 – Aurora María Rojo Sanchís, Head of GCP and GVP Inspectorate Spanish Agency of Medicines and Medical Devices (AEMPS)
4.45 – Iva Novak, Head of European Pharmacovigilance and EU QPPV | Teva
5.05 – Round Table
Moderator: G.N. Catiglione
Panelists: AIFA Representative; M. D’Antuono | Piramal , I. Novak; A.M. Rojo Sanchís
5.30 – Closure of the Congress
Scientific Advisory Group 2024 - In Progress...
Andrew Bate
VP, Head of Safety Innovation & Analytics | GSK
Glyn Belcher
Senior Scientific Advisor | EU PV
Congress
Mattia Calissano
Head of Pharmacovigilance | Orchard Therapeutics
Gian Nicola Castiglione
Pharmacovigilance Senior Consultant, Member and Secretary of SIMeF, ETS Board, Master of Labor. Past Head of Global Pharmacovigilance and EU-UK QPPV | Chiesi Farmaceutici S.p.A.
Mircea Ciuca
Global Therapeutic Area Head in Global Clinical Safety and Pharmacovigilance
Giovanni Furlan
Worldwide Safety Site Lead – Thessaloniki (Greece), Safety Risk Lead, Director | Pfizer S.r.l.
Calin A. Lungu
DDCS S.A., CEO
Hrvoje Maček
VP, Medical & Scientific Affairs, EU QPPV | PrimeVigilance
Valentina Mancini
Senior Director Pharmacovigilance, QPPV | Shionogi Europe
Jan Petracek
CEO | iVigee
Director, Institute of Pharmacovigilance
Marco Sardella
Chief Pharmacovigilance Officer & EU-UK QPPV| ADIENNE Pharma & Biotech
Speakers 2024 - In Progress...
John -Joseph Borg
Director Post-Licensing | Malta Medicines Authority
Roxana Dondera
Head of Pharmacovigilance and Risk Management Unit | National Agency for Medicine and Medical Devices of Romania
Fazil Afzal
Medical Assessor | Medicines and Healthcare products Regulatory Agency (MHRA)
Felix Arellano
Senior Vice President and the Global Head of Safety & Risk Management | Roche
Phil Tregunno
Deputy Director, Patient Safety Monitoring, Safety and Surveillance | MHR
Scott Proestel
VP, Medical Informatics |Medpace,Inc., former Senior Medical Officer | FDA (tbc)
Glyn Belcher
Senior Scientific Advisor | EU PV Congress
Lembit Rägo
Secretary-General | Council for International Organizations of Medical Sciences (CIOMS)
Sofia Trantza
Senior Pharmacovigilance Expert , PRAC member Greece
Calin A. Lungu
DDCS S.A., CEO
Terenzio Ignoni
SVP Quality and CMC | Gain Therapeutics
Arduino Mangoni
Strategic Professor in Clinical Pharmacology | Flinders University; Senior Consultant in Clinical Pharmacology and General Medicine, Adelaide, Australia
Andrew Bate
VP Safety Innovation & Analytics | GSK
Gabriel Westman
Head of Artificial Intelligence | Swedish Medical Products Agency
Anne De Groot
CEO/CSO and Director | Epivax
Robert Massouh
Head of (PV) Risk Management and Benefit Risk Evaluation | Gsk
Nicholas Moore
Emeritus Professor of Clinical Pharmacology | University of Bordeaux
Chia Yu Chu
Prof. Department of Dermatology | National Taiwan University
Georgios Papazisis
Professor of Clinical Pharmacology; Medical Director, Clinical Research Unit | School of Medicine, Aristotle University of Thessaloniki
Fabio De Gregorio
Vice President, Head of Drug Safety Europe | Shionogi Europe
Mayssa AbouGhannam
Country Safety Team Lead, Saudi Arabia, Gulf, Pakistan, Afghanistan | Johnson & Johnson
Marcin Kruk
Drug Safety Regional Head Europe , Africa, Middle East, Worlwide Medical & Safety |Pfizer Inc.
Elena Prokofyeva
Head of safety in clinical trials unit, DG Post, FAMHP
Amalia Alexe
PV Policy and Liaison Lead, QPPV Office | Novartis
Amy Rosemberg
Senior Director and Consultant, Immunology | EpiVax, Inc
Maurizio Sessa
Associate Professor of Pharmacoepidemiology | University of Copenhagen
Geeta Shanbhag
VP Pharmacovigilance and Medico-Regulatory Affairs | Ipca Laboratories Ltd
Giovanna Paolone
Associate Professor of Pharmacology – Department of Diagnostics and Public Health | University of Verona
Alqenae Fatema
Pharmacist | University of Manchester –
Winner EUPV 2024 Award
Dina B. Tresnan
Disease Area Cluster Lead -Immunolo-Oncology; Safety
Surveillance and Risk Management, Worldwide Safety | Pfizer
Ilaria Grisoni
Executive Director, Head of EU/International PV & Office of QPPV, EEA QPPV | Jazz Pharmaceuticals
Vibha Jawa
Executive Director | Bristol Myers Squibb
Klaudija Marijanovic Barac
Sr. Director, EU&UK QPPV Deputy, Head Periodic Reports and Risk Management Centre | TEVA
Zeljana Margan Koletic
Senior Manager, Risk Management Plans (RMP) Team Leader | Teva
Iva Novak
Head of European Pharmacovigilance and EU QPPV | Teva
Marcela Fialova
Chief Operating Officer | iVigee
Margherita D'Antuono
EU-UK QPPV| Piramal Critical Care
Aurora María Rojo Sanchís
Head of GCP and GVP Inspectorate Spanish Agency of Medicines and Medical Devices (AEMPS)
Marco Greco
European Patients’ Forum President (EPF)
Maddalena Lino
Safety Risk Lead Director | Pfizer
Daniela Marcozzi
Head of Corporate Clinical Safety, Pharmacovigilance and R&D Compliance QP for Pharmacovigilance EU & UK, Graduated Plan Officer AMG 63a
Company Representative for Competent Health Authorities
Barbara Kovačić Bytyqi
Head of Department for Pharmacovigilance and Rational Pharmacotherapy | HALMED
Paola Kruger
Expert Patient | EUPATI (European Patient’s Academy for Therapeutic Innovation)
Iva Kuliš
Principal Coordinator for Information in PV and Rational Pharmacotherapy, Dept for PV and Rational Pharmacotherapy | HALMED
Michael Von Forstner
Head of Safety Science| Sobi
Aoibhinn McDonnell
Safety Risk Lead, Director, Safety Surveillance and Risk Management | Pfizer
Natalia Kalousova Kocankova
Senior Strategic Advisor, EU QPPV Office Director | PrimeVigilance
Mercedina del Papa
Strategic Advisor, EU QPPV | Prime Vigilance
Sponsors & Media Partners 2024 - In Progress...
Baupharma
Silver Sponsor
Baupharma
Silver Sponsor
Baupharma, headquartered in Prague, is a premier pharmaceutical service provider with over 25 years of industry experience. Our international team offers comprehensive services—including pharmacovigilance, regulatory affairs, medical writing, batch release and distribution, translations, and clinical research—across the EU, MENA region, CIS, Africa, USA, LATAM, and beyond. With offices in Czech Republic, Saudi Arabia, UAE and Egypt, we ensure efficient project management and collaboration, delivering tailored solutions that meet the unique needs of each market.
Visit our website »
Insuvia
Bronze Sponsor
Insuvia
Bronze Sponsor
Insuvia is designed to act as a pharmacovigilance unit for pharmaceutical companies in those countries and regions, where they have no internal structures or decide to focus their resources on commercial activities. In this context, we provide the regional EU and country-level expertise to solve all pharmacovigilance challenges that pharmaceutical companies encounter while commercializing their products.
Visit our website »
iVigee
Gold Plus Sponsor
iVigee
Gold Plus Sponsor
iVigee is a leading pharmacovigilance services and technology company focused on creating simple, powerful, and elegant drug safety solutions that span the entire drug safety life cycle.
We combine years of experience with the latest innovative AI technologies to create the ‘instant pharmacovigilance department’, deployable anywhere, on-demand.
Our teams support clients around the world with progressive pharmacovigilance and data management requirements from our strategic bases in Central Europe and the US East Coast.
iVigee: Simple. Powerful. Elegant.
Visit our website »
Pharma D&S
Exhibitor
Pharma D&S
Exhibitor
Pharma D&S is an European Service Provider active in Lifescience field with a panel of more than 180 consultants who provide and support pharmaceutical companies in Pharmacovigilance, Clinical Research, Regulatory Affairs and Quality needs. We are partner whit over 400 companies by managing different areas of the product’s entire lifecycle and our customers can find a range of services and a multidisciplinary activities. We believe in the Relationship and client’s Loyalty, in understanding and sharing their goals, integrating with their staff and processes. We trust People, fostering their growth and promoting their commitment. We believe in Innovation and Creativity, in seeking constantly new approaches, ideas and solutions.
Visit our website »
Accuvigil Private Limited
Sponsor
Accuvigil Private Limited
Sponsor
Accuvigil is a dynamic newcomer in the world of pharmacovigilance, with its revolutionary approach and unparalleled commitment to drug safety and regulatory excellence. Our seasoned pharmacovigilance experts bring 30 years of combined experience to ensure the safety and efficacy of your products throughout their lifecycle. We offer comprehensive end-to-end pharmacovigilance solutions, making us the ideal partner for PV outsourcing for companies with or without established PV infrastructure. We provide top-notch services at competitive prices by harnessing the latest knowledge and state-of-the-art software from our strategic SAAS partnerships. Choose Accuvigil for proactive and dependable pharmacovigilance support, safeguarding both your brand and public health.
Visit our website »
PrimeVigilance
Gold Sponsor
PrimeVigilance
Gold Sponsor
PrimeVigilance, an Ergomed company, has grown to become the leading Pharmacovigilance specialist company, delivering global solutions for clinical safety and post-marketing pharmacovigilance and medical information from our operational hubs based in Europe, the USA, and Japan.
Our extensive experience enables us to offer a comprehensive, top-quality, cost-effective, and innovative safety solution. Our flexible approach, tailor-made to work with clients, allows us to deliver the services that meet your clinical and post-marketing needs.
PrimeVigilance provides pharmacovigilance solutions to over 200 clients who distribute their products worldwide. PrimeVigilance manages a global Pharmacovigilance system with a choice of leading drug safety databases stretching to more than 100 countries.
Visit our website »
Sage
Media Partner
Sage
Media Partner
Published by SAGE, Therapeutic Advances in Drug Safety (Impact Factor: 4.4) is an international peer-reviewed Open Access journal, delivering the highest quality original research articles, reviews, and scholarly comment on pioneering efforts and innovative studies pertaining to the safe use of drugs in patients. The journal has a strong clinical and pharmacological focus and is aimed at an international audience of clinicians and researchers in drug safety, providing an online forum for rapid dissemination of recent research and perspectives in this area.
As the official Media Partner of the 6th edition of the European Pharmacovigilance Congress, Therapeutic Advances in Drug Safety will be publishing an online abstract supplement which will be free to access online.
For more information:
E-mail: jonathan.collin@sagepub.co.uk
Twitter: @TADrugSafety
Visit our website »
Max Application
Exhibitor
Max Application
Exhibitor
Max Application is an IT company specialized in software solutions and focused on continuity, competence and passion in service.
Oracle partner for over 20 years, it offers cloud and on-premise solutions for sectors such as textile manufacturing, automotive and in mainly healthcare. The flagship of the latter is SafetyDrugs, the leading safety database for pharmacovigilance in Italy, accompanied by the Business Intelligence module, essential for Signal Detection.
Always committed to innovation, now part of Abacus Group, it benefits from the synergies and opportunities offered by this strategic partnership in areas such as IT infrastructure, cybersecurity, system integration and artificial intelligence.
Visit our website »
Become a sponsor
The European Pharmacovigilance Congress provides an excellent opportunity to get in touch with PV professionals and decision makers through a powerful virtual exhibition area. To sponsor the event, contact us.
Conference Venue
Step 1
On November 18-19 the event will be VIRTUAL to grant you the possibility of joining the conference even from your office or home, wherever you may be. We have organized a true virtual location, a space where you will be able to:
- Follow the live streaming of the congress, listen to experts and opinion makers and be informed about latest trends and technological breakthroughs in drug safety
- Visit the VIRTUAL EXHIBITION AREA and all the stands of our sponsors
- Join Q&A times and round tables to discuss the current hot topics in the field
- Chat with our sponsors and learn about new technologies and services to ease your daily work and increase the performance
Step 2
Let’s finally meet face to face in Milan on November 22! A great chance to meet in person the EUPV experts and colleagues. A great chance to meet in person the EUPV experts and colleagues. The conference will be hosted in the wonderful spaces of NH Milano Congress Centre, in Assago, Milan.
By plane
From Malpensa Airport:
-
- take the bus to the central station, then the subway towards Assago Milanofiori Forum
- take the express train from Malpensa to the Cadorna station, then the Green subway in the direction of Assago Milanofiori Forum.
From Linate Airport:
take the bus to San Babila station, then the subway towards Assago Milanofiori Forum.
By train
From Centrale or Cadorna train station, take green line subway to Assago Milanofiori Forum.
By tram
From Piazza del Duomo:
take the red subway line towards RHO FIERAMILANO and change at CADORNA. Take the green line towards ASSAGO MILANOFIORI FORUM and get off at the Assago Milanofiori Forum stop. Walk for about 7 minutes to reach the hotel.
Sign up for the conference
Face-to-Face (22/11/24) |
400€ |
Virtual (18-19/11/24) |
600€ |
Virtual + Face to Face (18-19/11/24 e 22/11/24) |
750€ |
* Hospitals, Universities and freelancers get a 40% discount on published prices (discounts cannot be combined).