European Pharmacovigilance Congress 2025

19-20 November 2025
Online
English
 
28 November 2025
Face-to-Face in Milan
English
 

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.

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


SESSION 1 - ADVANCING SIGNAL DETECTION IN PHARMACOVIGILANCE: MODERN METHODOLOGIES AND BEST PRACTICES

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.

SESSION 2 - RISK MANAGEMENT

(Content in development)

SESSION 3 - (PARALLEL) SAFETY OF COMBINATION PRODUCTS

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.

SESSION 4 - IMPORTANCE OF REAL-WORLD DATA SOURCES AND EVIDENCE BEYOND SPONTANEOUS REPORTING (in progress)

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.

SESSION 5 - (PARALLEL) COSMETOVIGILANCE

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.

SESSION 6 - PATIENTS’ REPRESENTATIVES CONTRIBUTION TO PV

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.

SESSION 7 - (PARALLEL) NON EU PV REQUIREMENTS

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.

SESSION 8 - LECTIO MAGISTRALIS

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


SESSION 9 - AUTHORITIES REVIEW OF PV DATA FROM CLINICAL DEVELOPMENT TO WHEN THINGS GO WRONG (in progress)

(Content in development)

SESSION 10 - BENEFIT/RISK EVALUATION OF MEDICINAL PRODUCTS

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.

SESSION 11 - (PARALLEL) LABELLING: A FUNDAMENTAL RISK COMMUNICATION AND MINIMIZATION TOOL

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.

SESSION 12 - REGULATORY ASPECTS FOR IMPLEMENTING ARTIFICIAL INTELLIGENCE IN PV

AI is the buzzword in PV, but do we know how to implement it according to regulatory requirements and expectations?

SESSION 13 - (PARALLEL) AGGREGATE REPORTS AROUND THE WORLD

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.

SESSION 14 - IMMUNOLOGICALLY DRIVEN ADVERSE REACTIONS

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.

SESSION 15 - (PARALLEL) PRACTICAL EXAMPLES OF AI IMPLEMENTATION IN PV PROCESSES

A session showcasing real-world examples of AI technologies to streamline pharmacovigilance workflow and improve outcomes.

SESSION 16 - LECTIO MAGISTRALIS

(Content in development)

NOVEMBER 28 | Milan


SESSION 17 - OVERCOMING CHALLENGES AND PRIORITIZING VALUE IN THE EVOLVING PV LANDSACAPE

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.

SESSION 18 - PERSONALIZED PV

Personalized medicine and treatment is one of the most recent advancements in the medical field. Where are we with personalized pharmacovigilance?

SESSION 19 F2F WORKSHOP - PARALLEL held by PRIMEVIGILANCE

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

SESSION 20 - PRAC AND OTHER EUROPEAN AUTHORITY PROCESSES FOR MONITORING THE BENEFIT RISK OF DRUGS

Gaining insights directly from PRAC members and European regulators on how benefit-risk assessments are conducted across the EU regulatory framework.

SESSION 21 - (PARALLEL) NEW SKILLS NEEDED IN PV

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.

SESSION 22 - PRE & POST MARKETING AUDITS & INSPECTIONS

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

Felix Arellano

Senior Vice President and the Global Head of Safety & Risk Management | Roche

Andrew Bate

Andrew Bate

VP, Head of Safety Innovation & Analytics | GSK

Glyn Belcher

Glyn Belcher

Honorary Member Scientific Advisory Group EUPV Congress 2025

Mattia Calissano

Mattia Calissano

Head of Pharmacovigilance | Orchard Therapeutics

Gian Nicola Castiglione

Gian Nicola Castiglione

Pharmacovigilance Senior Consultant, Member and Secretary of SIMeF, ETS Board, Master of Labor. Head of Pharmacovigilance and QPPV

Mircea Ciuca

Mircea Ciuca

Global Therapeutic Area Head in Global Clinical Safety and Pharmacovigilance

Giovanni Furlan

Giovanni Furlan

Head Medical Safety Operations | Sandoz Germany

Calin A. Lungu

Calin A. Lungu

DDCS S.A., CEO

Hrvoje Maček

Hrvoje Maček

VP, Medical & Scientific Affairs, EU QPPV | PrimeVigilance

Valentina Mancini

Valentina Mancini

Senior Director Pharmacovigilance, QPPV | Shionogi Europe

Jan Petracek

Jan Petracek

CEO | iVigee, Director | Institute of Pharmacovigilance

Marco Sardella

Marco Sardella

Chief Pharmacovigilance Officer & EU-UK QPPV| ADIENNE Pharma & Biotech

SPEAKERS 2025 IN PROGRESS


Marko Korenjac

Marko Korenjac

President of the European Liver Patients’ Association, former PRAC member

Ana Sofia Martins

Ana Sofia Martins

PRAC Member | INFARMED, I.P. – Portugal

Petar Mas

Petar Mas

PRAC HALMED

João A. Pedras-Vasconcelos

João A. Pedras-Vasconcelos

Senior Pharmaceutical Scientist (Product Quality and Immunogenicity) CDER Integrative Immunogenicity Working Group Co-chair – FDA (tbc)

Sophia Trantza

Sophia Trantza

Senior Pharmacovigilance Expert former PRAC Member Greece

Antonella Caselli

Antonella Caselli

Senior Clinical & Safety Assessor | Italian Medicines Agency (AIFA), Italy (Tbc)

Cristina Arizmendi Vélez

Cristina Arizmendi Vélez

Chief of Cosmetovigilance and Safety of Cosmetic Products | AEMPS

Lembit Rägo

Lembit Rägo

Secretary-General | Council for International
Organizations of Medical Sciences (CIOMS)

Pilar Rayón

Pilar Rayón

PRAC AEMPS

Lina Seibokiene

Lina Seibokiene

Senior expert at the Pharmacovigilance and Poison Information Unit, SMCA / PRAC alternate member.

Phil Tregunno

Phil Tregunno

Deputy Director, Patient Safety Monitoring, Safety and Surveillance | MHR (tbc)

Ana Maria Velasco Calle

Ana Maria Velasco Calle

GCP/GVP Inspector from the Spanish Agency of Medicines and Medical Devices

Elena Giovani

Elena Giovani

Head of the GVP Inspection Office | AIFA (Tbc)

Elena Prokofyeva

Elena Prokofyeva

Head of safety in clinical trials unit, DG Post, FAMHP

Dirk Mentzer

Dirk Mentzer

Head of Pharmacovigilance | Paul-Ehrlich-Institut (PEI)

Anita Blackburn

Anita Blackburn

Labeling Lead | Fortrea

Taxiarchis Botsis

Taxiarchis Botsis

Associate Professor | Johns Hopkins University School of Medicine – USA

Giuseppe Curigliano

Giuseppe Curigliano

Professor of Medical Oncology | University of Milano and European Institute of Oncology, IRCCS

Vjera Bilusic Vundac

Vjera Bilusic Vundac

Senior Director, Medical Writing | Primevigilance Ltd.-Croatia

Barbara De Bernardi

Barbara De Bernardi

EU & UK Pharmacovigilance Qualified Person, VP, Head of Global QPPV Office Worldwide Medical & Safety | Pfizer

Ahmed Diaa Eldin

Ahmed Diaa Eldin

CEO | Baupharma

Margherita D'Antuono

Margherita D'Antuono

EU-UK QPPV | Piramal Critical Care

Arduino Mangoni

Arduino Mangoni

Strategic Professor in Clinical Pharmacology | Flinders University; Senior Consultant in Clinical Pharmacology and General Medicine, Adelaide, Australia

Tina Amini

Tina Amini

Director TA MedTech & Combination Products Consulting Ltd

Panos Tsintis

Panos Tsintis

Medical Director | PLM Med Ltd – UK

François  Haguinet

François Haguinet

Associate Director for Safety and Quantitative Innovation | GSK – Belgium

Hanae Bourji Chergui

Hanae Bourji Chergui

Regulatory Affairs Senior Specialist | Becton and Dickinson

Ayman Ayoub

Ayman Ayoub

Labelling Lead, Research & Development | Pfizer – UK

Marie-Laure Kurzinger

Marie-Laure Kurzinger

Associate VP, Head of Pharmacoepidemiology – General Medicines, Pharmacovigilance and Patient Safety | Sanofi

Rory Littlebury

Rory Littlebury

Head of PV System Oversight and QPPV Office | GSK – UK

Rajat Mohindra

Rajat Mohindra

Principal Medical Director, Precision Safety, Product Development Safety | F. Hoffmann-La Roche Ltd – SWISS

Valeria Di Clemente

Valeria Di Clemente

Director Pharmacovigilance EU Cluster and LATAM | Baxter

Natasa Mihajlovic

Natasa Mihajlovic

Managing Director | Nostra Pharma

Antoine Pariente

Antoine Pariente

Professor of Clinical Pharmacology and Pharmacoepidemiology, Head of the Public Health Research Department | Univ. Bordeaux

Hadir Rostom

Hadir Rostom

President of ISoP Egypt Chapter

Adrian Roth

Adrian Roth

Principal Scientific Director Precision Safety, Pharma Development | Roche – Swiss

Michael Glaser

Michael Glaser

Safety Innovation Technology Director | GSK  – USA

Ilaria Grisoni

Ilaria Grisoni

Exec. Dir., Head of EU/International PV & Office of QPPV, EEA QPPV | Jazz Pharmaceuticals

Mariangela Amoroso

Mariangela Amoroso

Country Medical Lead | Sanofi Italy

Lisa Stagi

Lisa Stagi

Patient Safety Country Cluster Lead | Roche

Nancy Dreyer

Nancy Dreyer

Chief Scientific Officer retired IQVIA and Professor | Univ of North Carolina, Chapel Hill – USA

Michael Von Forstner

Michael Von Forstner

Head of Safety Science| Sobi

Fabio De Gregorio

Fabio De Gregorio

Vice President, Head of Safety | Shionogi Europe – UK

Klaudija Marijanovic Barac

Klaudija Marijanovic Barac

Sr. Director, Head of Teva Periodic reports and risk management Centre | Teva

Fazil Afzal

Fazil Afzal

Senior Medical Assessor at Medicines and Healthcare products Regulatory Agency (MHRA) (tbc)

Antonella Fretta

Antonella Fretta

Senior Director | Pfizer

Marco Greco

Marco Greco

Lawyer and EPF President

Alberto Gramaccioli

Alberto Gramaccioli

Director of Quality Management and Inspection | Pfizer

MEDIA PARTNER/COLLABORATIONS/SPONSORS 2025 IN PROGRESS

Sage

Media Partner
Sage

Institute of Pharmacovigilance

Collaboration
Institute of Pharmacovigilance

Baupharma

Silver Sponsor
Baupharma

Biomapas

Exhibitor
Biomapas

Clinpharma

Exhibitor
Clinpharma

Insuvia

Exhibitor
Insuvia

iVigee

Platinum Sponsor
iVigee

Max Application

Exhibitor
Max Application

Medical Affairs Consulting

Exhibitor
Medical Affairs Consulting

NostraPharma

Gold Sponsor
NostraPharma

Pharma D&S

Exhibitor
Pharma D&S

PrimeVigilance

Gold Plus Sponsor
PrimeVigilance

ProductLife Group

Exhibitor
ProductLife Group

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

The European Pharmacovigilance Congress 2025 will be a mixed event:

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.

All the past editions

Download brochures from previous editions of European Pharmacovigilance Congress 2025

Sign up for the conference

Face to Face (28/11/25)
Early bird until 16/10/2025*

400€
500€

Virtual (19-20/11/25)
Early bird until 16/10/2025*

600€
650€

Virtual + Face to Face (19-20/11/25 e 28/11/25)
Early bird until 16/10/2025*

750€
950€

* Hospitals, Universities and freelancers get a 40% discount on published prices (discounts cannot be combined).

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