European Pharmacovigilance Congress 2025


Conference overview
The European Pharmacovigilance Congress, organized by Pharma Education Center, is recognized as one of the most important and appreciated global pharmacovigilance conferences for the very high scientific content.
The high value of the 2025 congress edition is assured by the Scientific Advisory Group: a team of internationally renown key opinion leaders in charge of defining the congress content and
identifying the most knowledgeable, prestigious and eloquent speakers.
This year the importance of the congress will further increase thanks to the collaboration of the Institute of Pharmacovigilance.
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.
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
The 8th European Pharmacovigilance Congress: speaker abstracts 2024
Published by Sage Journals, visit their website here
Format del congresso
The European Pharmacovigilance Congress 2025 will be a mixed event!
19-20 November | Virtual 9 am – 6 pm
27 November | PV Workshop + Evening Cocktail, NH Milano Congress Centre 5 – 9 pm
28 November | Face to face, NH Milano Congress Centre 9 am – 5 pm
EVENING COCKTAIL November 27 from 6 to 9 pm
At the conference venue, PEC organizes a Welcome evening cocktail that will take place together with interesting workshops. Reserve your place to meet and network with your colleagues and experts!
This year the congress will includes:
– 22 Topics
– 20 interactives round tables
– 6 virtual parallel sessions
– 2 face to face parallel 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
AGENDA 2025
- ADVANCING SIGNAL DETECTION IN PHARMACOVIGILANCE: MODERN METHODOLOGIES AND BEST PRACTICES
- IMMUNOLOGICALLY DRIVEN ADVERSE REACTIONS
- INTEGRATING REAL WORD DATA AND EVIDENCE IN PV
- PATIENTS’ ASSOCIATIONS CONTRIBUTION TO PV
- ANTIBODIES’ INFLUENCE ON THE SAFETY PROFILE OF BIOLOGICAL PRODUCTS
- SAFETY OF COMBINATION PRODUCTS
- AUTHORITIES’ REVIEW OF PV DATA FROM MARKETING AUTHORIZATION APPLICATION TO WHEN THINGS GO WRONG
- PRAC AND OTHER EUROPEAN AUTHORITY PROCESSES FOR MONITORING THE BENEFIT RISK OF DRUGS
- LABELLING: A FUNDAMENTAL RISK COMMUNICATION AND MINIMIZATION TOOL
- REGULATORY ASPECTS FOR IMPLEMENTING ARTIFICIAL INTELLIGENCE IN PV
- PRACTICAL EXAMPLES OF AI IMPLEMENTATION IN PV PROCESSES
- APPLYING THEORY OF GAMES IN PV: HOW CAN WE AUTOMATE REINFORCED LAERNING FOR PV LARGE LANGUAGE MODELS?
- AGGREGATE REPORTS AROUND THE WORLD
- RISK MANAGEMENT
- OVERCOMING CHALLENGES AND PRIORITIZING VALUE IN THE EVOLVING PV LANDSCAPE
- NEW SKILLS NEEDED IN PV
- PERSONALIZED PV
- BENEFIT-RISK EVALUATION OF MEDICINAL PRODUCTS
- PV AUDITS & INSPECTIONS
NOVEMBER 19 | Virtual
Signal detection is a fundamental task to identify the new or evolving risks associated with medicinal products. This session will discuss how advancements in technology are shaping this practice emphasizing the critical role of high-quality data in generating meaningful safety signals.
(Content in development)
Devices are being increasingly used together with medicinal products and new regulatory frameworks have been introduced to assess the safety of these combination products. However, despite their growing importance, these topics remain frequently under discussed; therefore, this session is a valuable learning opportunity.
Real-world evidence is a hot topic that has been recently presented in CIOMS XIII report. Building on the learnings of this report, this session will focus on leveraging diverse real-world data sources to generate meaningful safety insights beyond traditional methodologies.
The safety of cosmetics has lots of commonalities with pharmacovigilance but is neglected by most pharmacovigilance scientists. This session is an opportunity to learn more about this science that is closely related to pharmacovigilance.
Everything we do in pharmacovigilance is for the benefit of the patients. Engaging with patient representatives, incorporating their perspectives, listening to what they have to say on the safety of medicinal products and taking consequential actions is of crucial importance to maximize the benefit-risk balance of medicinal products and to build trust.
Inspections play a key role in ensuring compliance with local pharmacovigilance requirements. This session highlights the paramount importance of understanding them and integrating them in a global pharmacovigilance system.
Not all medicinal products, especially biologicals, with the same non-proprietary name are equal. This is a unique opportunity to explore how variations in product quality can affects their immunogenicity and hence their safety profile.
NOVEMBER 20 | Virtual
(Content in development)
The ultimate goal of pharmacovigilance has always been to ensure patients receive treatments with the most favorable benefit-risk profile. CIOMS XII working group is providing the most up to date suggestions on how to evaluate benefit-risk.
The label has a critically important role in conveying safety information to healthcare professional and patients. This session examines how labels can effectively communicate the necessary information on how to maximize drug benefits and reduce their risks.
AI is the buzzword in PV, but do we know how to implement it according to regulatory requirements and expectations?
Aggregate reports, highlighting the latest and cumulative safety information for every medicinal product during its whole life cycle, are required by regulatory authorities in almost every country. This session reviews some global requirements, the challenges of non-harmonized regulations and emerging trends in safety reporting.
Pharmacovigilance is not only about processes, regulations and efficiency. Most importantly it`s about science. This session offers a deeper understanding of how the interactions between the immune system and a medicinal product cause adverse reactions.
A session showcasing real-world examples of AI technologies to streamline pharmacovigilance workflow and improve outcomes.
(Content in development)
NOVEMBER 28 | Milan
An overview of how to overcome the current and future challenges we are facing and will tackle in pharmacovigilance. What are the lessons we have learned and how we can leverage them to make our work more meaningful.
Personalized medicine and treatment is one of the most recent advancements in the medical field. Where are we with personalized pharmacovigilance?
Introduction by the Chairperson, Felix Arellano
Precision oncology in the era of molecular tumor board, Giuseppe Curigliano
Applying advanced analytics in precision safety, Rajat Mohindra
Novel human cell models to characterize toxicity, Adrian Roth
Round Table | F. Arellano, G. Curigliano, R. Mohindra, A Roth
Aword Ceremony
Gaining insights directly from PRAC members and European regulators on how benefit-risk assessments are conducted across the EU regulatory framework.
As all sciences, also pharmacovigilance has and is rapidly evolving due to new technologies and methodologies. PV professionals need to continuously adapt by updating their skillset. This session outlines the newly required competencies to meet emerging scientific and technological demands.
The session that traditionally closes EU PV congress: compliance is the “ticket to ride” of every pharmacovigilance system that gives credibility to the work we do every day.
Scientific Advisory Group 2025
Felix Arellano
Senior Vice President and the Global Head of Safety & Risk Management | Roche
Andrew Bate
VP, Head of Safety Innovation & Analytics | GSK
Glyn Belcher
Honorary Member Scientific Advisory Group EUPV Congress 2025
Mattia Calissano
Head of Pharmacovigilance | Orchard Therapeutics
Gian Nicola Castiglione
Pharmacovigilance Senior Consultant, Member and Secretary of SIMeF, ETS Board, Master of Labor. Head of Pharmacovigilance and QPPV
Mircea Ciuca
Global Therapeutic Area Head in Global Clinical Safety and Pharmacovigilance
Giovanni Furlan
Head Medical Safety Operations | Sandoz Germany
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 2025 IN PROGRESS
Marko Korenjac
President of the European Liver Patients’ Association, former PRAC member
Ana Sofia Martins
PRAC Member | INFARMED, I.P. – Portugal
Petar Mas
PRAC HALMED
João A. Pedras-Vasconcelos
Senior Pharmaceutical Scientist (Product Quality and Immunogenicity) CDER Integrative Immunogenicity Working Group Co-chair – FDA (tbc)
Sophia Trantza
Senior Pharmacovigilance Expert former PRAC Member Greece
Antonella Caselli
Senior Clinical & Safety Assessor | Italian Medicines Agency (AIFA), Italy (Tbc)
Cristina Arizmendi Vélez
Chief of Cosmetovigilance and Safety of Cosmetic Products | AEMPS
Lembit Rägo
Secretary-General | Council for International
Organizations of Medical Sciences (CIOMS)
Pilar Rayón
PRAC AEMPS
Lina Seibokiene
Senior expert at the Pharmacovigilance and Poison Information Unit, SMCA / PRAC alternate member.
Phil Tregunno
Deputy Director, Patient Safety Monitoring, Safety and Surveillance | MHR (tbc)
Ana Maria Velasco Calle
GCP/GVP Inspector from the Spanish Agency of Medicines and Medical Devices
Elena Giovani
Head of the GVP Inspection Office | AIFA (Tbc)
Elena Prokofyeva
Head of safety in clinical trials unit, DG Post, FAMHP
Dirk Mentzer
Head of Pharmacovigilance | Paul-Ehrlich-Institut (PEI)
Anita Blackburn
Labeling Lead | Fortrea
Taxiarchis Botsis
Associate Professor | Johns Hopkins University School of Medicine – USA
Giuseppe Curigliano
Professor of Medical Oncology | University of Milano and European Institute of Oncology, IRCCS
Vjera Bilusic Vundac
Senior Director, Medical Writing | Primevigilance Ltd.-Croatia
Barbara De Bernardi
EU & UK Pharmacovigilance Qualified Person, VP, Head of Global QPPV Office Worldwide Medical & Safety | Pfizer
Ahmed Diaa Eldin
CEO | Baupharma
Margherita D’Antuono
EU-UK QPPV | Piramal Critical Care
Arduino Mangoni
Strategic Professor in Clinical Pharmacology | Flinders University; Senior Consultant in Clinical Pharmacology and General Medicine, Adelaide, Australia
Tina Amini
Director TA MedTech & Combination Products Consulting Ltd
Panos Tsintis
Medical Director | PLM Med Ltd – UK
François Haguinet
Associate Director for Safety and Quantitative Innovation | GSK – Belgium
Hanae Bourji Chergui
Regulatory Affairs Senior Specialist | Becton and Dickinson
Ayman Ayoub
Labelling Lead, Research & Development | Pfizer – UK
Marie-Laure Kurzinger
Associate VP, Head of Pharmacoepidemiology – General Medicines, Pharmacovigilance and Patient Safety | Sanofi
Rory Littlebury
Head of PV System Oversight and QPPV Office | GSK – UK
Rajat Mohindra
Principal Medical Director, Precision Safety, Product Development Safety | F. Hoffmann-La Roche Ltd – SWISS
Valeria Di Clemente
Director Pharmacovigilance EU Cluster and LATAM | Baxter
Natasa Mihajlovic
Managing Director | Nostra Pharma
Antoine Pariente
Professor of Clinical Pharmacology and Pharmacoepidemiology, Head of the Public Health Research Department | Univ. Bordeaux
Hadir Rostom
President of ISoP Egypt Chapter
Adrian Roth
Principal Scientific Director Precision Safety, Pharma Development | Roche – Swiss
Michael Glaser
Safety Innovation Technology Director | GSK – USA
Ilaria Grisoni
Exec. Dir., Head of EU/International PV & Office of QPPV, EEA QPPV | Jazz Pharmaceuticals
Mariangela Amoroso
Country Medical Lead | Sanofi Italy
Lisa Stagi
Patient Safety Country Cluster Lead | Roche
Nancy Dreyer
Chief Scientific Officer retired IQVIA and Professor | Univ of North Carolina, Chapel Hill – USA
Michael Von Forstner
Head of Safety Science| Sobi
Fabio De Gregorio
Vice President, Head of Safety | Shionogi Europe – UK
Klaudija Marijanovic Barac
Sr. Director, Head of Teva Periodic reports and risk management Centre | Teva
Fazil Afzal
Senior Medical Assessor at Medicines and Healthcare products Regulatory Agency (MHRA) (tbc)
Antonella Fretta
Senior Director | Pfizer
Marco Greco
Lawyer and EPF President
Alberto Gramaccioli
Director of Quality Management and Inspection | Pfizer
MEDIA PARTNER/COLLABORATIONS/SPONSORS 2025 IN PROGRESS
Sage
Media Partner
Sage
Media Partner
Published by SAGE, Therapeutic Advances in Drug Safety (Impact Factor: 3.4) 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: shasha.sharief@sagepub.co.uk
Twitter: @TADrugSafety
Visit our website »
Institute of Pharmacovigilance
Collaboration
Institute of Pharmacovigilance
Collaboration
Founded in 2015, the Institute of Pharmacovigilance (IPV) is a not-for-profit, non-governmental global organization with a clear goal – to elevate the pharmacovigilance industry by competency and seniority certification.
In 2020, IPV partnered with the International Society of Pharmacovigilance (ISoP) to develop the Global Pharmacovigilance Professional Certification (GPPC), creating a globally recognized standard for PV professionals. The certification works with competency standards including knowledge, skills and attitudes suitable for every role in pharmacovigilance.
Committed to continuous innovation, IPV regularly updates its programs to reflect the latest advancements, ensuring certified professionals have practical knowledge and skills they can apply in their jobs immediately.
Visit our website »
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 »
Biomapas
Exhibitor
Biomapas
Exhibitor
A go-to life sciences outsourcing partner from drug development consultancy to post-authorisation support and strategic partnerships for Biopharma companies, delivering excellence in Europe & Globally.
Big enough to cover all your needs. Small enough to care.
Visit our website »
Clinpharma
Exhibitor
Clinpharma
Exhibitor
Clinpharma was born from the desire to offer our customers, operating in the chemical-pharmaceutical sector , a complete range of consultancy services. Each project represents an opportunity for us to demonstrate a solid set of skills and make use of a vast wealth of resources. Our objective is to provide a complete consultancy service to Pharmaceutical companies relating to pharmacovigilance activities (pre and post-marketing), cosmetovigilance, phytovigilance and Supervision of Medical Devices, Regulatory Affairs, Scientific Service, Market access and preparation of the price and reimbursement dossier . The company provides its consultancy in compliance with current European and national regulations and guidelines.
Visit our website »
Insuvia
Exhibitor
Insuvia
Exhibitor
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
Platinum Sponsor
iVigee
Platinum 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 »
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 »
Medical Affairs Consulting
Exhibitor
Medical Affairs Consulting
Exhibitor
Our goal is to ensure excellence in Pharmacovigilance, Medical Information and promoting a culture of Change in a Kaizen perspective throughout the drug life cycle.
Since 2001, our team has provided in-depth experience in the pharmaceutical industry to support our Clients’ needs in managing:
– complex pharmacovigilance processes (QPPV, Deputy-QPPV, safety database, case-processing, aggregated reports, signal detection, literature search, Eudravigilance, Art.57, QAPV, SOPs);
– Scientific training activities for the sales force.
– Support for the preparation, in compliance with the current regulations, of advertising and scientific information materials for pharmaceutical and medical device companies.
– Management consultancy with expertise in Lean Thinking and Kaizen Culture.
Visit our website »
NostraPharma
Gold Sponsor
NostraPharma
Gold Sponsor
Founded in 2008, NostraPharma is a leading consultancy with ISO 9001:2015 certification, specializing in pharmacovigilance (PV), quality, and training. With over 900 years of combined expertise, we offer customized, high-quality solutions to support clients throughout the PV and quality lifecycle. Our commitment to excellence ensures personalized services, enabling businesses to confidently navigate regulatory requirements. Key services include strategic PV/Quality consultancy, AI/algorithm and GxP auditing, QPPV, PSMF, inspection support, and PV system setup and improvement. We excel in managing complex situations, providing clients with the expertise to overcome regulatory challenges effectively and efficiently.
Visit our website »
Pharma D&S
Exhibitor
Pharma D&S
Exhibitor
Pharma D&S, a PLG Company, 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 »
PrimeVigilance
Gold Plus Sponsor
PrimeVigilance
Gold Plus 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 300 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 »
ProductLife Group
Exhibitor
ProductLife Group
Exhibitor
ProductLife Group’s mission is to improve human health by delivering regulatory compliance services for the safe and effective use of medical solutions.
Since 30 years, PLG supports clients through the entire product life cycle, combining local expertise with global reach spanning more than 150 countries. It provides consulting and outsourcing services in the areas of regulatory affairs, quality and compliance, market access, vigilances and medical information, covering both established products and innovative therapeutics & diagnostics.
With a goal of continuously improving the value delivered to people and customers, PLG is committed to long-term partnership, innovation, flexibility, and cost efficiency.
Visit our website »
Become a sponsor
Don’t miss the chance to be a European Pharmacovigilance Congress 2025 sponsor!
Contact us to learn about our sponsorship packages, you will have the opportunity to:
• Deliver a talk in person or online
• Conduct a parallel session during the day in Milan
• Network and connect with your target customers
Conference Venue
Step 1
On November 19-20 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
COCKTAIL DINNER November 27, 2025 (NH Milano Congress Centre, in Assago, Milan)
Let’s finally meet face to face in Milan on November 28! 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.
If you need Visa, contact in**@*******************er.it. Please, consider that we apply a fee for the Visa Request Letter Service.
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 for the very high scientific content.
The high value of the 2025 congress edition is assured by the Scientific Advisory Group: a team of internationally renown key opinion leaders in charge of defining the congress content and
identifying the most knowledgeable, prestigious and eloquent speakers.
This year the importance of the congress will further increase thanks to the collaboration of the Institute of Pharmacovigilance.
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.
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
The 8th European Pharmacovigilance Congress: speaker abstracts 2024
Published by Sage Journals, visit their website here
Format del congresso
The European Pharmacovigilance Congress 2025 will be a mixed event!
19-20 November | Virtual 9 am – 6 pm
27 November | PV Workshop + Evening Cocktail, NH Milano Congress Centre 5 – 9 pm
28 November | Face to face, NH Milano Congress Centre 9 am – 5 pm
EVENING COCKTAIL November 27 from 6 to 9 pm
At the conference venue, PEC organizes a Welcome evening cocktail that will take place together with interesting workshops. Reserve your place to meet and network with your colleagues and experts!
This year the congress will includes:
– 22 Topics
– 20 interactives round tables
– 6 virtual parallel sessions
– 2 face to face parallel 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
AGENDA 2025
- ADVANCING SIGNAL DETECTION IN PHARMACOVIGILANCE: MODERN METHODOLOGIES AND BEST PRACTICES
- IMMUNOLOGICALLY DRIVEN ADVERSE REACTIONS
- INTEGRATING REAL WORD DATA AND EVIDENCE IN PV
- PATIENTS’ ASSOCIATIONS CONTRIBUTION TO PV
- ANTIBODIES’ INFLUENCE ON THE SAFETY PROFILE OF BIOLOGICAL PRODUCTS
- SAFETY OF COMBINATION PRODUCTS
- AUTHORITIES’ REVIEW OF PV DATA FROM MARKETING AUTHORIZATION APPLICATION TO WHEN THINGS GO WRONG
- PRAC AND OTHER EUROPEAN AUTHORITY PROCESSES FOR MONITORING THE BENEFIT RISK OF DRUGS
- LABELLING: A FUNDAMENTAL RISK COMMUNICATION AND MINIMIZATION TOOL
- REGULATORY ASPECTS FOR IMPLEMENTING ARTIFICIAL INTELLIGENCE IN PV
- PRACTICAL EXAMPLES OF AI IMPLEMENTATION IN PV PROCESSES
- APPLYING THEORY OF GAMES IN PV: HOW CAN WE AUTOMATE REINFORCED LAERNING FOR PV LARGE LANGUAGE MODELS?
- AGGREGATE REPORTS AROUND THE WORLD
- RISK MANAGEMENT
- OVERCOMING CHALLENGES AND PRIORITIZING VALUE IN THE EVOLVING PV LANDSCAPE
- NEW SKILLS NEEDED IN PV
- PERSONALIZED PV
- BENEFIT-RISK EVALUATION OF MEDICINAL PRODUCTS
- PV AUDITS & INSPECTIONS
NOVEMBER 19 | Virtual
Signal detection is a fundamental task to identify the new or evolving risks associated with medicinal products. This session will discuss how advancements in technology are shaping this practice emphasizing the critical role of high-quality data in generating meaningful safety signals.
(Content in development)
Devices are being increasingly used together with medicinal products and new regulatory frameworks have been introduced to assess the safety of these combination products. However, despite their growing importance, these topics remain frequently under discussed; therefore, this session is a valuable learning opportunity.
Real-world evidence is a hot topic that has been recently presented in CIOMS XIII report. Building on the learnings of this report, this session will focus on leveraging diverse real-world data sources to generate meaningful safety insights beyond traditional methodologies.
The safety of cosmetics has lots of commonalities with pharmacovigilance but is neglected by most pharmacovigilance scientists. This session is an opportunity to learn more about this science that is closely related to pharmacovigilance.
Everything we do in pharmacovigilance is for the benefit of the patients. Engaging with patient representatives, incorporating their perspectives, listening to what they have to say on the safety of medicinal products and taking consequential actions is of crucial importance to maximize the benefit-risk balance of medicinal products and to build trust.
Inspections play a key role in ensuring compliance with local pharmacovigilance requirements. This session highlights the paramount importance of understanding them and integrating them in a global pharmacovigilance system.
Not all medicinal products, especially biologicals, with the same non-proprietary name are equal. This is a unique opportunity to explore how variations in product quality can affects their immunogenicity and hence their safety profile.
NOVEMBER 20 | Virtual
(Content in development)
The ultimate goal of pharmacovigilance has always been to ensure patients receive treatments with the most favorable benefit-risk profile. CIOMS XII working group is providing the most up to date suggestions on how to evaluate benefit-risk.
The label has a critically important role in conveying safety information to healthcare professional and patients. This session examines how labels can effectively communicate the necessary information on how to maximize drug benefits and reduce their risks.
AI is the buzzword in PV, but do we know how to implement it according to regulatory requirements and expectations?
Aggregate reports, highlighting the latest and cumulative safety information for every medicinal product during its whole life cycle, are required by regulatory authorities in almost every country. This session reviews some global requirements, the challenges of non-harmonized regulations and emerging trends in safety reporting.
Pharmacovigilance is not only about processes, regulations and efficiency. Most importantly it`s about science. This session offers a deeper understanding of how the interactions between the immune system and a medicinal product cause adverse reactions.
A session showcasing real-world examples of AI technologies to streamline pharmacovigilance workflow and improve outcomes.
(Content in development)
NOVEMBER 28 | Milan
An overview of how to overcome the current and future challenges we are facing and will tackle in pharmacovigilance. What are the lessons we have learned and how we can leverage them to make our work more meaningful.
Personalized medicine and treatment is one of the most recent advancements in the medical field. Where are we with personalized pharmacovigilance?
Introduction by the Chairperson, Felix Arellano
Precision oncology in the era of molecular tumor board, Giuseppe Curigliano
Applying advanced analytics in precision safety, Rajat Mohindra
Novel human cell models to characterize toxicity, Adrian Roth
Round Table | F. Arellano, G. Curigliano, R. Mohindra, A Roth
Aword Ceremony
Gaining insights directly from PRAC members and European regulators on how benefit-risk assessments are conducted across the EU regulatory framework.
As all sciences, also pharmacovigilance has and is rapidly evolving due to new technologies and methodologies. PV professionals need to continuously adapt by updating their skillset. This session outlines the newly required competencies to meet emerging scientific and technological demands.
The session that traditionally closes EU PV congress: compliance is the “ticket to ride” of every pharmacovigilance system that gives credibility to the work we do every day.
Scientific Advisory Group 2025
Felix Arellano
Senior Vice President and the Global Head of Safety & Risk Management | Roche
Andrew Bate
VP, Head of Safety Innovation & Analytics | GSK
Glyn Belcher
Honorary Member Scientific Advisory Group EUPV Congress 2025
Mattia Calissano
Head of Pharmacovigilance | Orchard Therapeutics
Gian Nicola Castiglione
Pharmacovigilance Senior Consultant, Member and Secretary of SIMeF, ETS Board, Master of Labor. Head of Pharmacovigilance and QPPV
Mircea Ciuca
Global Therapeutic Area Head in Global Clinical Safety and Pharmacovigilance
Giovanni Furlan
Head Medical Safety Operations | Sandoz Germany
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 2025 IN PROGRESS
Marko Korenjac
President of the European Liver Patients’ Association, former PRAC member
Ana Sofia Martins
PRAC Member | INFARMED, I.P. – Portugal
Petar Mas
PRAC HALMED
João A. Pedras-Vasconcelos
Senior Pharmaceutical Scientist (Product Quality and Immunogenicity) CDER Integrative Immunogenicity Working Group Co-chair – FDA (tbc)
Sophia Trantza
Senior Pharmacovigilance Expert former PRAC Member Greece
Antonella Caselli
Senior Clinical & Safety Assessor | Italian Medicines Agency (AIFA), Italy (Tbc)
Cristina Arizmendi Vélez
Chief of Cosmetovigilance and Safety of Cosmetic Products | AEMPS
Lembit Rägo
Secretary-General | Council for International
Organizations of Medical Sciences (CIOMS)
Pilar Rayón
PRAC AEMPS
Lina Seibokiene
Senior expert at the Pharmacovigilance and Poison Information Unit, SMCA / PRAC alternate member.
Phil Tregunno
Deputy Director, Patient Safety Monitoring, Safety and Surveillance | MHR (tbc)
Ana Maria Velasco Calle
GCP/GVP Inspector from the Spanish Agency of Medicines and Medical Devices
Elena Giovani
Head of the GVP Inspection Office | AIFA (Tbc)
Elena Prokofyeva
Head of safety in clinical trials unit, DG Post, FAMHP
Dirk Mentzer
Head of Pharmacovigilance | Paul-Ehrlich-Institut (PEI)
Anita Blackburn
Labeling Lead | Fortrea
Taxiarchis Botsis
Associate Professor | Johns Hopkins University School of Medicine – USA
Giuseppe Curigliano
Professor of Medical Oncology | University of Milano and European Institute of Oncology, IRCCS
Vjera Bilusic Vundac
Senior Director, Medical Writing | Primevigilance Ltd.-Croatia
Barbara De Bernardi
EU & UK Pharmacovigilance Qualified Person, VP, Head of Global QPPV Office Worldwide Medical & Safety | Pfizer
Ahmed Diaa Eldin
CEO | Baupharma
Margherita D'Antuono
EU-UK QPPV | Piramal Critical Care
Arduino Mangoni
Strategic Professor in Clinical Pharmacology | Flinders University; Senior Consultant in Clinical Pharmacology and General Medicine, Adelaide, Australia
Tina Amini
Director TA MedTech & Combination Products Consulting Ltd
Panos Tsintis
Medical Director | PLM Med Ltd – UK
François Haguinet
Associate Director for Safety and Quantitative Innovation | GSK – Belgium
Hanae Bourji Chergui
Regulatory Affairs Senior Specialist | Becton and Dickinson
Ayman Ayoub
Labelling Lead, Research & Development | Pfizer – UK
Marie-Laure Kurzinger
Associate VP, Head of Pharmacoepidemiology – General Medicines, Pharmacovigilance and Patient Safety | Sanofi
Rory Littlebury
Head of PV System Oversight and QPPV Office | GSK – UK
Rajat Mohindra
Principal Medical Director, Precision Safety, Product Development Safety | F. Hoffmann-La Roche Ltd – SWISS
Valeria Di Clemente
Director Pharmacovigilance EU Cluster and LATAM | Baxter
Natasa Mihajlovic
Managing Director | Nostra Pharma
Antoine Pariente
Professor of Clinical Pharmacology and Pharmacoepidemiology, Head of the Public Health Research Department | Univ. Bordeaux
Hadir Rostom
President of ISoP Egypt Chapter
Adrian Roth
Principal Scientific Director Precision Safety, Pharma Development | Roche – Swiss
Michael Glaser
Safety Innovation Technology Director | GSK – USA
Ilaria Grisoni
Exec. Dir., Head of EU/International PV & Office of QPPV, EEA QPPV | Jazz Pharmaceuticals
Mariangela Amoroso
Country Medical Lead | Sanofi Italy
Lisa Stagi
Patient Safety Country Cluster Lead | Roche
Nancy Dreyer
Chief Scientific Officer retired IQVIA and Professor | Univ of North Carolina, Chapel Hill – USA
Michael Von Forstner
Head of Safety Science| Sobi
Fabio De Gregorio
Vice President, Head of Safety | Shionogi Europe – UK
Klaudija Marijanovic Barac
Sr. Director, Head of Teva Periodic reports and risk management Centre | Teva
Fazil Afzal
Senior Medical Assessor at Medicines and Healthcare products Regulatory Agency (MHRA) (tbc)
Antonella Fretta
Senior Director | Pfizer
Marco Greco
Lawyer and EPF President
Alberto Gramaccioli
Director of Quality Management and Inspection | Pfizer
MEDIA PARTNER/COLLABORATIONS/SPONSORS 2025 IN PROGRESS
Sage
Media Partner
Sage
Media Partner
Published by SAGE, Therapeutic Advances in Drug Safety (Impact Factor: 3.4) 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: shasha.sharief@sagepub.co.uk
Twitter: @TADrugSafety
Visit our website »
Institute of Pharmacovigilance
Collaboration
Institute of Pharmacovigilance
Collaboration
Founded in 2015, the Institute of Pharmacovigilance (IPV) is a not-for-profit, non-governmental global organization with a clear goal – to elevate the pharmacovigilance industry by competency and seniority certification.
In 2020, IPV partnered with the International Society of Pharmacovigilance (ISoP) to develop the Global Pharmacovigilance Professional Certification (GPPC), creating a globally recognized standard for PV professionals. The certification works with competency standards including knowledge, skills and attitudes suitable for every role in pharmacovigilance.
Committed to continuous innovation, IPV regularly updates its programs to reflect the latest advancements, ensuring certified professionals have practical knowledge and skills they can apply in their jobs immediately.
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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.
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Biomapas
Exhibitor
Biomapas
Exhibitor
A go-to life sciences outsourcing partner from drug development consultancy to post-authorisation support and strategic partnerships for Biopharma companies, delivering excellence in Europe & Globally.
Big enough to cover all your needs. Small enough to care.
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Clinpharma
Exhibitor
Clinpharma
Exhibitor
Clinpharma was born from the desire to offer our customers, operating in the chemical-pharmaceutical sector , a complete range of consultancy services. Each project represents an opportunity for us to demonstrate a solid set of skills and make use of a vast wealth of resources. Our objective is to provide a complete consultancy service to Pharmaceutical companies relating to pharmacovigilance activities (pre and post-marketing), cosmetovigilance, phytovigilance and Supervision of Medical Devices, Regulatory Affairs, Scientific Service, Market access and preparation of the price and reimbursement dossier . The company provides its consultancy in compliance with current European and national regulations and guidelines.
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Insuvia
Exhibitor
Insuvia
Exhibitor
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.
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iVigee
Platinum Sponsor
iVigee
Platinum 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.
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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.
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Medical Affairs Consulting
Exhibitor
Medical Affairs Consulting
Exhibitor
Our goal is to ensure excellence in Pharmacovigilance, Medical Information and promoting a culture of Change in a Kaizen perspective throughout the drug life cycle.
Since 2001, our team has provided in-depth experience in the pharmaceutical industry to support our Clients’ needs in managing:
– complex pharmacovigilance processes (QPPV, Deputy-QPPV, safety database, case-processing, aggregated reports, signal detection, literature search, Eudravigilance, Art.57, QAPV, SOPs);
– Scientific training activities for the sales force.
– Support for the preparation, in compliance with the current regulations, of advertising and scientific information materials for pharmaceutical and medical device companies.
– Management consultancy with expertise in Lean Thinking and Kaizen Culture.
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NostraPharma
Gold Sponsor
NostraPharma
Gold Sponsor
Founded in 2008, NostraPharma is a leading consultancy with ISO 9001:2015 certification, specializing in pharmacovigilance (PV), quality, and training. With over 900 years of combined expertise, we offer customized, high-quality solutions to support clients throughout the PV and quality lifecycle. Our commitment to excellence ensures personalized services, enabling businesses to confidently navigate regulatory requirements. Key services include strategic PV/Quality consultancy, AI/algorithm and GxP auditing, QPPV, PSMF, inspection support, and PV system setup and improvement. We excel in managing complex situations, providing clients with the expertise to overcome regulatory challenges effectively and efficiently.
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Pharma D&S
Exhibitor
Pharma D&S
Exhibitor
Pharma D&S, a PLG Company, 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.
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PrimeVigilance
Gold Plus Sponsor
PrimeVigilance
Gold Plus 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 300 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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ProductLife Group
Exhibitor
ProductLife Group
Exhibitor
ProductLife Group’s mission is to improve human health by delivering regulatory compliance services for the safe and effective use of medical solutions.
Since 30 years, PLG supports clients through the entire product life cycle, combining local expertise with global reach spanning more than 150 countries. It provides consulting and outsourcing services in the areas of regulatory affairs, quality and compliance, market access, vigilances and medical information, covering both established products and innovative therapeutics & diagnostics.
With a goal of continuously improving the value delivered to people and customers, PLG is committed to long-term partnership, innovation, flexibility, and cost efficiency.
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Become a sponsor
Don’t miss the chance to be a European Pharmacovigilance Congress 2025 sponsor!
Contact us to learn about our sponsorship packages, you will have the opportunity to:
• Deliver a talk in person or online
• Conduct a parallel session during the day in Milan
• Network and connect with your target customers
Conference Venue
Step 1
On November 19-20 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
COCKTAIL DINNER November 27, 2025 (NH Milano Congress Centre, in Assago, Milan)
Let’s finally meet face to face in Milan on November 28! 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.
If you need Visa, contact in**@*******************er.it. Please, consider that we apply a fee for the Visa Request Letter Service.
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 (28/11/25) | 400€ |
Virtual (19-20/11/25) | 600€ |
Virtual + Face to Face (19-20/11/25 e 28/11/25) | 750€ |
* Hospitals, Universities and freelancers get a 40% discount on published prices (discounts cannot be combined).