European Pharmacovigilance Congress 2026

18-19 November 2026
Online
English
 
3-4 December 2026
Face-to-Face in Milan, Italy
English
 

Panoramica della conferenza

Become sponsor of European Pharmacovigilance Congress 2026, click here

The European Pharmacovigilance Congress, organized by Pharma Education Center, is recognized as one of the most important and appreciated global pharmacovigilance conferences thanks to its top-tier scientific content.
The high value of this year`s program is assured by the contribution of the key opinion leaders, experts and scientists included in the Scientific Advisory Group (SAG).

In addition, we are delighted to announce the new scientific partnership with the renowned
Department of Pharmacological and Biomolecular Sciences of the Milan University (Universitร  degli Studi di Milano) and the confirmation of collaboration with the Institute of Pharmacovigilance.

The EUPV Scientific Advisory Group has very clear that pharmacovigilance main pillars are:
โ€ข Safety Science – Regulatory compliance – Operational excellence
โ€ข Implementation of new technologies – Effective communication
All these aspects are reflected in the agenda of this year’s congress.

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.

 

PLEASE NOTE:
Ticket options labeled โ€˜+ Visaโ€™ are intended for participants who need to request a visa invitation letter in order to attend the event. If you need more information contact info@pharmaeducationcenter.it

Format del congresso

The European Pharmacovigilance Congress 2026 will be a mixed event!

November 18-19 | Virtual (9.00 – 5.30 pm)
December 3 | Milan* (3.00 – 7.00 pm) + Networking Aperitivo (7.00 – 9.00 pm)
December 4 | Milan* (9.15 – 5.30 pm)

* at NH Milan Congress Centre

NETWORKING APERITIVO December 3 (7.00 – 9.00 pm)
At the conference venue, PEC organizes a Networking Aperitivo that will take place together with interesting workshops. Reserve your place to meet and network with your colleagues and experts: Networking Aperitivo

The intense, scientific interaction between speakers and delegates is a further invaluable plus of the event:
– 27 Topics
– 24 round tables
– 7 virtual parallel sessions
– 1 LECTIO Magistralis
– 3 F2F parallel workshops

Perchรจ partecipare?

  • 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

A chi รจ rivolto?

  • 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 2026

NOVEMBER 18 | VIRTUAL


SESSION 1 - DEVELOPMENTAL SAFETY FROM FIRST IN HUMAN TO MARKETING AUTHORIZATION APPLICATION

In progress..

SESSION 2 - TRANSLATION SAFETY

Translational safety is the science of predicting adverse reactions that may occur in humans by integrating preclinical and clinical data across drug development. Early and reliable prediction of risks associated with an investigational medicinal product can increase the likelihood of successful development and, most importantly, safeguards subjects participating in clinical trials.

SESSION 3 - (PARALLEL) SAFETY OF GENE THERAPIES AND RARE DISEASES

In progress..

SESSION 4 - NON-EU PV REQUIREMENTS (ASIA โ€“ AFRICA)

Pharmacovigilance outside the EU presents a highly dynamic regulatory landscape, shaped by local publicโ€‘health priorities and evolving legal frameworks. This session will take us across Asia and Africa, highlighting how global principles translate into regional practice. Pharmacovigilance systems must be reviewed to ensure alignment with these requirements.

SESSION 5 - (PARALLEL) SYNTHETIC DATA IN PHARMACOVIGILANCE: OPPORTUNITIES, RISKS AND REGULATORY REALITY

The era of AI has paved the road to completely new possibilities that would have been unthinkable only a few years ago. This session looks into the near future by discussing the use of artificially generated datasets that mimic real drug-safety data.

SESSION 6 - SAFETY ASPECTS OF NEW PRODUCTS USED FOR THE TREATMENT OF INFLAMMATORY DISORDERS

While the methodologies to assess the risks of medicinal products are common throughout all therapeutic areas, each of them requires specific considerations. This session focuses on important safety aspects that have required investigation for new products indicated in inflammatory disorders

SESSION 7 - (PARALLEL) SAFETY IN ACCELERATED PATHWAYS

In progress..

LECTIO MAGISTRALIS

SAFETY OF DRUGS USED IN HEPATIC RARE DISEASES (A DISCUSSION AT THE EUROPEAN PARLIAMENT)

A unique opportunity to hear firstโ€‘hand about a discussion held at one of Europeโ€™s most important institutions, presented directly by the speaker involved sharing information that can be publicly disclosed.

NOVEMBER 19 | VIRTUAL


SESSION 9 - IMPACT OF NEW REGULATIONS AND GUIDELINES ON PV OPERATIONS

In progress..

SESSION 10 - REGULATORY REQUIREMENTS FOR IMPLEMENTING AI IN PV

In progress..

SESSION 11 - (PARALLEL) MEDICAL DEVICES & COMBINATION PRODUCTS SAFETY

In progress..

SESSION 12 - PRACTICAL EXAMPLES OF APPLYING AI TO PV

AI has been a key buzzword in pharmacovigilance over recent years, yet its practical implementation remains a challenge. This session focuses on methodologies and realโ€‘world examples that illustrate how AI can be effectively implemented in pharmacovigilance practice.

SESSION 13 - (PARALLEL) SAFETY INFORMATION FROM PATIENTSยดPERSPECTIVE

In progress..

SESSION 14 - NON-EU PV REQUIREMENTS: UK & Americas

In progress..

SESSION 15 - (PARALLEL) COSMETOVIGILANCE AND SAFETY OF NUTRACEUTICALS PRODUCTS

Pharmacovigilance professionals are often not fully aware of closely related disciplines, such as cosmetics and nutraceutical safety, and of the potential impact these products may have on drug safety. This session aims to provide an overview of these areas

SESSION 16 - EMA COMPUTERIZED SYSTEMS UPDATES

All pharmacovigilance stakeholders, including regulators, are continuously enhancing their digital tools. This session enables participants to stay up to date with changes in EMA systems, such as EudraVigilance and the Clinical Trials Information System (CTIS).

SESSION 17 - (PARALLEL) ECOPHARMACOVIGILANCE

In progress..

DECEMBER 3 | MILAN


SESSION 18 - RISK MANAGEMENT SYSTEMS

The aim of pharmacovigilance is to identify the most important risks associated with a medicinal product and to minimise them, ensuring a positive benefitโ€“risk balance. This session provides insights into how to establish an effective risk management system, including in particularly challenging situations.

SESSION 19 - PHARMACOEPIDEMIOLOGY AND REAL-WORLD EVIDENCE IN PHARMACOVIGILANCE: FROM SIGNAL TO DECISION

The unprecedented volume of patient data available today offers new opportunities to transform data into meaningful evidence. Pharmacoepidemiology and realโ€‘world evidence play a central role in identifying, quantifying, and characterizing risks, supporting more informed and robust regulatory decisionโ€‘making.

SESSION 20 - WHAT IS AI AND ITS IMPLEMENTATION IN CASE PROCESSING

Many of us talk about AI without realizing it encompasses a range of different technologies, each with distinct characteristics, advantages, and limitations. This session introduces the fundamentals of AI and illustrates its practical application through a realโ€‘life example in case processing.

SESSION 21 - WORKSHOP "HUMAN MACHINE INTERFACE IN PV"

BY IVIGEE

DECEMBER 4 | MILAN


SESSION 22 - EFFICIENCY AND EFFECTIVENESS IN A RAPIDLY CHANGING PV LANDSCAPE

In progress..

SESSION 23 - DECISIONS THAT MATTER: REAL LIFE IMPACT OF DRUG SAFETY WORK

Pharmacovigilance is grounded in scientific disciplines such as biology and pharmacology, which underpin medicine safety from nonโ€‘clinical research through clinical development and shape risk management strategies. This session offers realโ€‘world insights into the value of applying scientific principles to drug safety.

SESSION 24 (PARALLEL) โ€“ WORKSHOP: MASTERING SAUDI/GCC PHARMACOVIGILANCE 2026

BY BAUPHARMA

SESSION 25 - SIGNAL DETECTION AND MANAGEMENT: THE USE OF RWD/RWE, THE USE OF AI AND POSSIBLE LIMITATIONS

Applying artificial intelligence to realโ€‘world evidence is one of todayโ€™s most prominent topics. But what do regulators think? This session offers a rare opportunity to hear directly from PRAC members and leading scientists on how AI can be used to transform realโ€‘world data into robust evidence for signal detection and management.

SESSION 26 (PARALLEL) - WORKSHOP

In progress…

SESSION 27 - PV AUDIT & INSPECTIONS

The session that traditionally closes the EU PV Congress is also one of its most important. Compliance -and the successful outcome of audits and inspections- represents the true โ€œlicense to operateโ€ in pharmacovigilance and across the pharmaceutical industry.

Scientific Advisory Group 2026


Felix Arellano

Felix Arellano

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

Ayman Ayoub

Ayman Ayoub

Vice President Safety Evaluation and Risk Management | GSK

Mattia Calissano

Mattia Calissano

VP, Medical | SSI Strategy

Gian Nicola Castiglione

Gian Nicola Castiglione

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

Manuela Casula

Manuela Casula

Associate Professor at Department of Pharmacological and Biomolecular Sciences | University of Milan

Mircea Ciuca

Mircea Ciuca

Global Therapeutic Area Head in Global Clinical Safety and Pharmacovigilance

Giovanni Furlan

Giovanni Furlan

Head Medical Safety Operations | Sandoz

Calin A. Lungu

Calin A. Lungu

DDCS S.A., CEO

Hrvoje Maฤek

Hrvoje Maฤek

VP Pharmacovigilance Services | Clingen

Valentina Mancini

Valentina Mancini

Senior Director Pharmacovigilance, QPPV | Shionogi Europe

Arduino Mangoni

Arduino Mangoni

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

Jan Petracek

Jan Petracek

CEO |ย iVigee, Director | Institute of Pharmacovigilance

Marco Sardella

Marco Sardella

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

Ivana ล utalo

Ivana ล utalo

Innovative Products, Business Unit Lead / EU QPPV / LCPPV Croatia | PrimeVigilance Ltd.

SPEAKERS 2026 IN PROGRESS


Marko Korenjak

Marko Korenjak

President of the European Liver Patients (ELPA), member of HMA management board of EMA – Slovenia

Ana Sofia Martins

Ana Sofia Martins

PRAC Member | INFARMED, I.P. – Portugal

Sophia Trantza

Sophia Trantza

Senior Pharmacovigilance Expert, former PRAC Member Greece

Andrew Bate

Andrew Bate

VP, Head of Safety Innovation & Analytics | GSK – Uk

Lembit Rรคgo

Lembit Rรคgo

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

Pilar Rayรณn

Pilar Rayรณn

PRAC – AEMPS Spain

Annalisa Capuano

Annalisa Capuano

Full Professor of Pharmacology – Department of Experimental Medicine |ย  University of Campania โ€œL. Vanvitelliโ€ – Italy

Jens-Ulrich Stegmann

Jens-Ulrich Stegmann

Senior Vice President, Head Clinical Safety and Pharmacovigilance and EU QPPV | GSK – Belgium

Michelle English

Michelle English

GCP/PV Inspector | HPRA – Ireland

Elena Giovani

Elena Giovani

Head of the GVP Inspection Office | AIFA (Tbc)

Elena Prokofyeva

Elena Prokofyeva

Head of Clinical Trial Safety Unit, Department of Pharmacovigilance, DG POST | FAMHP – Belgium

Fazil Afzal

Fazil Afzal

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

Barbara De Bernardi

Barbara De Bernardi

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

Ahmed Diaa Eldin

Ahmed Diaa Eldin

CEO | Baupharma – Czech Republic

Marie-Laure Kurzinger

Marie-Laure Kurzinger

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

Rajat Mohindra

Rajat Mohindra

Principal Medical Director Personalized Healthcare Safety | F.Hoffmann – La Roche – Switzerland

Adrian Roth

Adrian Roth

Principal Scientific Director Precision Safety | Roche – Switzerland

Ilaria Grisoni

Ilaria Grisoni

Exec. Dir., Head of International QPPV Office, EEA QPPV | Jazz Pharmaceuticals – Italy

Michael Von Forstner

Michael Von Forstner

Managing Director | Mesa Laubela Consulting – Switzerland

Klaudija Marijanovic Barac

Klaudija Marijanovic Barac

Associate VP, EU QPPV Deputy | Eli Lilly Hrvatska d.o.o. – Croatia

Alberto Gramaccioli

Alberto Gramaccioli

Director of Quality Management and Inspection | Pfizer

Maria Beatrice Panico

Maria Beatrice Panico

Chief Medical Officer | Scendea – UK

Bogdana Ioana Balas

Bogdana Ioana Balas

Group Medical Director | F. Hoffmann – La Roche Ltd – Switzerland

Lucia Biagiotti

Lucia Biagiotti

Safety & Vigilance – BU Director | PL Italia

Alexandru Mihai Bica

Alexandru Mihai Bica

Head of Early Development Safety | CSL Behring – Germany

Mehmet Burcu

Mehmet Burcu

Senior Director, Epidemiology | Merck – USA

Marie-Pierre Caby-Tosi

Marie-Pierre Caby-Tosi

Executive Director, EEA/UK QPPV, Head of EMEA PV Clinical Safety & Pharmacovigilance | Moderna – France

Katerina Georgousaki

Katerina Georgousaki

Regulatory Affairs Manager | ELAIS-Unilever Hellas S.A., Greece

Ramona Grigorescu

Ramona Grigorescu

Senior Medical Monitor | Danone – Holland

Sadia Halim

Sadia Halim

SERM Medical Director | GSK – Uk

Daniel Hyde

Daniel Hyde

Associate Director, Pharmacovigilance Operations | Clinigen – UK

Ursula Kirchmayer

Ursula Kirchmayer

Pharmacoepidemiologist at the Department of Epidemiology | Lazio regional health service

Wojciech Maseล‚bas

Wojciech Maseล‚bas

SERM Medical Director | Gsk – Poland

James Milligan

James Milligan

Vice President | SSI – UK

Axelle Mutezinkwano

Axelle Mutezinkwano

Pharmacovigilance Analyst Team Lead | Rwanda Food and Drugs Authority

Kaori Nomura

Kaori Nomura

Associate Professor | Fukushima Medical University – Japan

Darmendra Ramcharran

Darmendra Ramcharran

Sr Director, Safety & Quantitative Innovation | GSK – USA

Hendrik ล uvalov

Hendrik ล uvalov

PhD Student in Health Informatics | University of Tartu – Estonia

Alina Tudor

Alina Tudor

Senior Director, Pharmacovigilance | Kyowa Kirin International plc. – UK

Jonathan Sutch

Jonathan Sutch

Principal Technical Specialist & Scheme Manager | BSI Group – UK

Amelia Cupelli

Amelia Cupelli

Pharmacologist, Italian Medicines Agency (AIFA), EMA PRAC Member, Italy

Salvo Leone

Salvo Leone

General Director | Patientโ€™s Association AMICI, Italy

Emanuele Lettieri

Emanuele Lettieri

Full Professor | Politecnico of Milan, Italy

Hans-Joerg Roemming

Hans-Joerg Roemming

Executive Director, Head of RQS Information, Systems & Insights | Merck Healthcare KGaA

MEDIA PARTNER/COLLABORATIONS/SPONSORS 2026 - in progress

Sage Publishing

Scientific Media Partner
Sage Publishing

Institute of Pharmacovigilance

Collaboration
Institute of Pharmacovigilance

Universitร  degli Studi di Milano - Dipartimento di Scienze Farmacologiche e Biomolecolari

Scientific Partnership
Universitร  degli Studi di Milano - Dipartimento di Scienze Farmacologiche e Biomolecolari

Baupharma

Silver Sponsor
Baupharma

Eureka InfoMed

Exhibitor
Eureka InfoMed

Insuvia

Exhibitor
Insuvia

iVigee

Platinum Sponsor
iVigee

ProductLife Group

Exhibitor
ProductLife Group

Diventa sponsor

Don’t miss the chance to be a European Pharmacovigilance Congress 2026 sponsor!

Contact us to learn about our sponsorship packages, you will have the opportunity to:
โ€ข Deliver a talk in person or online
โ€ข Conduct a parallel session during the day in Milan
โ€ข Network and connect with your target customers

Check out our sponsorship opportunities here:ย Become EUPV Sponsor

Sede del congresso

The European Pharmacovigilance Congress 2026 will be a mixed event:

Step 1

Onย November 18-19ย the event will beย 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 theย VIRTUAL EXHIBITION AREAย 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

Letโ€™s finally meet face to face in Milan on December 3-4! 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.
NETWORKING APERITIVO December 3, 2026 (NH Milano Congress Centre, in Assago, Milan)
–> If you would like to attend the Networking Aperitivo, please save your spot here: Networking Aperitivo

 

PLEASE NOTE:
Ticket options labeled โ€˜+ Visaโ€™ are intended for participants who need to request a visa invitation letter in order to attend the event. If you need more information contact info@pharmaeducationcenter.it

 

Arrivare in aereo

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.

Arrivare in treno

From Centrale or Cadorna train station, take green line subway to Assago Milanofiori Forum.

Arrivare in 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.

Edizioni precedenti

Scarica le brochure delle precedenti edizioni di European Pharmacovigilance Congress 2026

Iscriviti alla conferenza

Face to Face (3-4/12/2026)
Early bird fino al 23/09/2026*

450€
550€

Virtual (18-19/11/2026)
Early bird fino al 23/09/2026*

750€
800€

Virtual + Face to Face (18-19/11/2026 and 3-4/12/2026)
Early bird fino al 23/09/2026*

880€
1100€

If you would like to attend the NETWORKING APERITIVO, please save your spot here: Networking Aperitivo

Attendance to the event will be allowed upon receipt of payment.

* Ospedali, universitร  e liberi professionisti ottengono uno sconto del 40% da applicare ai prezzi pubblicati (gli sconti non sono cumulabili).

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