European Pharmacovigilance Congress 2023

27-28 November 2023
Online
English
 
1 December 2023
Face to face
English
 

Conference overview

The European Pharmacovigilance Congress, organized by Pharma Education Center, is recognized as one of the most important and appreciated conference on Pharmacovigilance.

Last year, delegates from more than 50 countries worldwide have joined the two days of virtual event followed by the day in presence in Milan.

Growing year after year, the European Pharmacovigilance Congress gathers professionals at all career levels, including key decision makers (e.g. Directors, VPs and Executives) interested in the always evolving pharmacovigilance world and its new trends, and willing to implement more efficient and effective strategies and tools for their departments.

To further improve the value of the congress, the Scientific Board has been widened with the addition of new prestigious, renowned international PV key opinion leaders.
Their deep knowledge and experience, as well as the involvement of excellent speakers on each topic, will ensure the highest scientific level of the program.

The main pharmacovigilance topics, including sessions on pharmacovigilance strategies and trends, new supporting technologies and sessions dedicated to regulatory scenarios from different countries will be covered.

The european pharmacovigilance congress will be a mixed event!

The first two days, November 27 and 28, will be virtual and will see the participation of worldwide experts and key opinion leaders.
The third day, December 1, will be a face to face meeting in Milan, where you will have the chance to meet colleagues and the speakers of the congress: a great opportunity for the PV community to get together!

Congress Format

Two days of virtual conference + one day of face to face meeting in Milan with:

  • Presentations & keynote speeches from World Class Speakers
  • Focused Round Tables and Q&A sessions participant involvement
  • Significant networking opportunities
  • Exhibition area for Emerging Technologies and PV solutions
  • Publication by Sage of the congress booklet containing the abstracts of presentations and the insights coming from the Round Tables

The European Pharmacovigilance Congress:

Is more than a traditional conference, it is a great opportunity to learn, to develop your professional skills, to get in touch with international renowned experts and colleagues. Discuss and share the strategies and the main trends in the international pharmacovigilance scenario: be part of the community!

Why attend?

  • Learn about the latest PV 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

Featured Topics 2023

  • Evolving Pharmacovigilance Strategies
  • Pharmacovigilance in Drug Development
  • Pharmacovigilance in ATMP
  • Regulations impacting on the global PV system
  • Extra-EU Pharmacovigilance regulatory requirements
  • Signal Detection & Risk minimization
  • Real World Evidence in Pharmacovigilance
  • Risk Communication
  • Applying Artificial Intelligence to Pharmacovigilance
  • Eduravigilance & CTIS Updates
  • Pharmacovigilance Quality System – Inspections & Audits
  • Pharmacoepidemilogy

27 November 2023 - VIRTUAL


INTRODUCTION DAY 1

Marco Sardella, Chief Pharmacovigilance Officer & EU QPPV /ADIENNE Pharma & Biotech
Arduino Mangoni, Strategic Professor in Clinical Pharmacology | Flinders University, Senior Consultant in Clinical Pharmacology and General Medicine, Adelaide, Australia

SESSION 1. MAIN GLOBAL PV UPDATES

Gian Nicola Castiglione, Director Global Pharmacovigilance, EU QPPV | Chiesi
Thierry Hamard, Pharmacovigilance & Regulatory Intelligence | Safety Observer
Marcela Fialova, COO and Co-founder | iVigee
Ilaria Grisoni, Executive Director, Head of EU/International PV & Global Risk Management and EEA QPPV | Jazz Pharmaceuticals

SESSION 2. SIGNAL DETECTION & RISK MINIMIZATION

Arduino Mangoni, Strategic Professor in Clinical Pharmacology | Flinders University, Senior Consultant in Clinical Pharmacology and General Medicine, Adelaide, Australia
Klaudija Marijanovic Barac, Sr. Director, EU&UK QPPV deputy, Head Periodic Reports & Risk Management Unit at TEVA
Qun-Ying Yue, Associate Professor, Senior Pharmacovigilance Expert | Uppsala Monitoring Centre
Zeljana Margan Koletic, Croatian PRAC Alternate Member, Head of Department for Pharmacovigilance and Rational Pharmacotherapy | HALMED
Annette Rudolph, Pharmacovigilance scientist | Uppsala Monitoring Centre

SESSION 3. REAL WORLD EVIDENCE IN PHARMACOVIGILANCE

Michael Von Forstner, Global Head, Patient Safety and Pharmacovigilance Biosimilars | Biogen International
Thomas Debray, Founder, Smart Data Analysis and Statistics B.V.
Susana Perez-Gutthann, Vice President, Global Head Epidemiology | RTI International
Gianluca Trifirò, Professore Ordinario di Farmacologia – Dipartimento di Diagnostica e Sanità Pubblica | Università di Verona

SESSION 4. APPLYING ARTIFICIAL INTELLIGENCE TO PV

Jan Petracek, CEO | iVigee, Director of Institute of Pharmacovigilance, ISoP Advisory Board
Kendal Harrison, Head of Vigilance Development MHRA
Maria Beatrice Panico, Principal consultant at Scendea
Marco Sardella, Chief Pharmacovigilance Officer & EU QPPV | ADIENNE Pharma & Biotech

SESSION 5. SIGNAL DETECTION & CAUSALITY ASSESSMENT (parallel session)

Ivona Bahnik Bisevac, Director Benefit-Risk Management | PrimeVigilance
Giovanni Furlan, Worldwide Safety Site Lead – Thessaloniki (Greece), Safety Risk Lead, Director | Pfizer S.r.l.
Slot reserved for the sponsor
Maddalena Lino, Safety risk Lead Director Pfizer

SESSION 6. LECTIO MAGISTRALIS

Nicholas Moore, Emeritus professor of clinical pharmacology | University of Bordeaux

28 November 2023 - VIRTUAL


INTRODUCTION DAY 2

Marco Sardella, Chief Pharmacovigilance Officer & EU QPPV | ADIENNE Pharma & Biotech
Arduino Mangoni, Strategic Professor in Clinical Pharmacology | Flinders University, Senior Consultant in Clinical Pharmacology and General Medicine, Adelaide, Australia

SESSION 7. EXTRA-EU-PHARMACOVIGILANCE REGULATORY REQUIREMENTS (UK-JAPAN-INDIA)

Margherita D’Antuono, EU-UK QPPV | Piramal Critical Care
Fazil Afzal, Senior Medical Assessor | Medicines and Healthcare products Regulatory Agency (MHRA)
Eriko Ogura, Global Head of Drug Safety | Shionogi & Co.,Ltd.
Niteeka Maroo, Head Pharmacovigilance | Piramal Group-India

SESSION 8. RISK COMMUNICATION

Hervé Le Louët, Head of PV policy intelligence strategy | Takeda, CIOMS President
Frederic Bouder, Professor in Risk Management, University of Stavanger, Norway
Anita Blackburn, Global Labeling Lead | Labcorp
Giovanni Furlan, Worldwide Safety Site Lead – Thessaloniki (Greece), Safety Risk Lead, Director | Pfizer S.r.l.
Nuccia Oneto, Patient Oriented Programmes Governance Lead | Novartis Italy

SESSION 9. EUDRAVIGILANCE: UPDATES (parallel session)

Chairperson PEC
Calin Lungu, DDCS S.A., CEO

SESSION 10. PV IN ATMP

Mattia Calissano, Head of Drug Safety and Italy and UK LPPV | Orchard Therapeutics
Jan Petracek, CEO | iVigee
Larissa Mege, Global Safety Officer, Sanofi Rare Diseases, Specialty Care Business Unit
Anne De Groot, CEO/CSO and Director | EpiVax

SESSION 11. CTIS: UPDATES (parallel session)

Mircea Ciuca, Global Therapeutic Area Head in Global Clinical Safety and Pharmacovigilance
Sara Lazzarin, Global Head of Pharmacovigilance Unit | OPIS s.r.l.
Vojtech Kvita, CVO, Co-Founder | NextPV Services

SESSION 12. PV IN SPECIAL POPULATIONS

Glyn Belcher, CEO of PV Consultancy Ltd
Amalia Alexe, Policy & Liaison Lead, QPPV PRRC Office | Novartis
Jennifer Stevenson, Consultant Pharmacist for Older People, Guy’s and St Thomas’ NHS Foundation TrusT

SESSION 13. EXTRA-EU-PHARMACOVIGILANCE REGULATORY REQUIREMENTS (MENA-LATAM-CHINA)

Valentina Mancini, Senior Director Pharmacovigilance QPPV | Shionogi Europe
Romina Fernanda Heredia, PV Intelligence Coordinator, Head of Project Managers and Business Development | PhV Latam
Lana Arafat, Associate Director, Pharmacovigilance | Hikma Pharmaceuticals
Gloria Bustos, Senior Director, Head of Pharmacovigilance EMEA and APAC | Baxter
Marco Sardella, Chief Pharmacovigilance Officer & EU QPPV | ADIENNE Pharma & Biotech

1 December 2023 - FACE-TO-FACE IN MILAN


INTRODUCTION DAY 3

Marco Sardella, Chief Pharmacovigilance Officer & EU QPPV /ADIENNE Pharma & Biotech
Arduino Mangoni, Strategic Professor in Clinical Pharmacology | Flinders University, Senior Consultant in Clinical Pharmacology and General Medicine, Adelaide, Australia

SESSION 14. EVOLVING PHARMACOVIGILANCE STRATEGIES

Lembit Rago, Secretary-General | Council for International Organizations of Medical Sciences (CIOMS)
Eriko Ogura, Global Head of Drug Safety- Shionogy
Ayman Ayoub, VP Business Unit Area Head Safety Surveillance & Risk Management | Pfizer
Andrew Bate, VP Safety Innovation & Analytics | GSK
Sophia Trantza, Senior pharmacovigilance expert
Anna Ruth van Troostenburg De Bruyn, Senior VP Pharmacovigilance & Epidemiology | Gilead Sciences

SESSION 15. PHARMACOVIGILANCE IN DRUG DEVELOPMENT

Mircea Ciuca, Global Therapeutic Area Head in Global Clinical Safety and Pharmacovigilance
Maria Beatrice Panico, Principal consultant at Scendea
Anne Ruth van Troostenburg De Bruyn, EU QPPV and VP Pharmacovigilance & Epidemiology | Gilead Sciences
Elena Prokofjeva, Head of the Drug Safety Team, R&D Department | DG PRE, FAMHP

SESSION 16. PV QUALITY SYSTEM - INSPECTION &AUDIT

Monica Da Luz Carvalho Soares, Health Regulatory Expert, Pharmacovigilance Adviser|Brazilian Health Surveillance Agency (Anvisa)
Calin Lungu, DDCS S.A., CEO
AIFA representative (invited)
PV inspector | FAGG -AFMPS (tbc)
Tea Babić, Director, Head of global PV audits and inspections | Teva Pharmaceuticals

SESSION 17. IMPLEMENTING EFFICIENCY IN PHARMACOVIGILANCE OPERATIONS

Hrvoje Maček, VP, Medical & Scientific Affairs, EU QPPV | PrimeVigilance
Marco Sardella, Chief Pharmacovigilance Officer & EU QPPV | ADIENNE Pharma & Biotech
Laura Boga, Head of Global Pharmacovigilance, EU&UK, QP for Pharmacovigilance | Dompé Farmaceutici S.p.A.
Lucia Biagiotti, EU & UK QPPV, Quality Assurance, Pharmacovigilance system assessment | Pharma D&S
Andrea Pieri, Business Development Director | Pharma D&S

Scientific board 2023


Glyn Belcher

Glyn Belcher

CEO | PV Consultancy Ltd

Mattia Calissano

Mattia Calissano

Head of Drug Safety and Italy and UK LPPV | Orchard Therapeutics

Mircea Ciuca

Mircea Ciuca

MD, Global Therapeutic Area Head in Global Clinical Safety and Pharmacovigilance

Lucia Costanzo

Lucia Costanzo

Senior Conference Manager at Pharma Education Center

Giovanni Furlan

Giovanni Furlan

Worldwide Safety Site Lead – Thessaloniki (Greece), Safety Risk Lead, Director | Pfizer S.r.l.

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 of iVigee, Director of Institute of Pharmacovigilance, ISoP Advisory Board

Marco Sardella

Marco Sardella

Chief Pharmacovigilance Officer & EU-UK QPPV | ADIENNE Pharma & Biotech, Chairperson for EUPV Congress

Confirmed speakers 2023


Fazil Afzal

Fazil Afzal

Medical Assessor | Medicines and Healthcare products Regulatory Agency (MHRA)

Amalia Alexe

Amalia Alexe

Policy & Liaison Lead, QPPV PRRC Office | Novartis

Lana Arafat

Lana Arafat

Associate Director, Pharmacovigilance | Hikma Pharmaceuticals

Ayman Ayoub

Ayman Ayoub

Vice President, Business Unit Area Head, Safety Surveillance and Risk Management | Pfizer

Tea Babić

Tea Babić

Director, Head of global PV audits and inspections | Teva Pharmaceuticals

Klaudija Marijanovic Barac

Klaudija Marijanovic Barac

Sr. Director, EU&UK QPPV deputy, Head Periodic Reports and Risk Management Unit | TEVA

Andrew Bate

Andrew Bate

VP Safety Innovation & Analytics | GSK

Anita Blackburn

Anita Blackburn

Global Labeling Lead | Labcorp

Lucia Biagiotti

Lucia Biagiotti

EU & UK QPPV | Quality Assurance, Pharmacovigilance system assessment | Pharma D&S

Laura Boga

Laura Boga

Head of Global Pharmacovigilance, EU&UK, QP for Pharmacovigilance | Dompé Farmaceutici S.p.A.

Raj Bhogal

Raj Bhogal

Senior Director, R&D Business Strategy & Operations | Jazz Pharmaceuticals

Frederic Emmanuel Bouder

Frederic Emmanuel Bouder

Professor in Risk Management, University of Stavanger, Norway

Gloria Bustos

Gloria Bustos

Senior Director, Head of Pharmacovigilance EMEA and APAC | Baxter

Azira Čajić

Azira Čajić

Head of Division for Pharmacovigilance and Materiovigilance| Agency for Medicinal Products and Medical Devices Bosnia & Herzegovina-ALMBIH

Gian Nicola Castiglione

Gian Nicola Castiglione

Director Global Pharmacovigilance | Chiesi Farmaceutici

David Chonzi

David Chonzi

Global Head of PVE | Instil Bio

Margherita D'Antuono

Margherita D'Antuono

EU-UK QPPV| Piramal Critical Care

Fabio De Gregorio

Fabio De Gregorio

Vice President, Head of Drug Safety Europe | Shionogi Europe

Anne De Groot

Anne De Groot

CEO/CSO and Director | Epivax

Thomas Debray

Thomas Debray

Founder, Smart Data Analysis and Statistics B.V.

Marcela Fialova

Marcela Fialova

Chief Operating Officer | iVigee

Alberto Gramaccioli

Alberto Gramaccioli

Director, Quality Management and Inspections, World Wide Safety | Pfizer inc.

Ilaria Grisoni

Ilaria Grisoni

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

Sarah Hall

Sarah Hall

Managing Director | Mipsol Limited

Thierry Hamard

Thierry Hamard

Director | Safety Observer

Dominique Hamerlijnck

Dominique Hamerlijnck

Fellow, Patient Expert | EUPATI (European Patient’s Academy for Therapeutic Innovation)

Kendal Harrison

Kendal Harrison

Head of Vigilance Development | Medicines and Healthcare products Regulatory Agency (MHRA)

Romina Fernanda Heredia

Romina Fernanda Heredia

PV Intelligence Coordinator, Head of Project Managers and Business Development | PhV Latam

Paola Kruger

Paola Kruger

Expert Patient | EUPATI (European Patient’s Academy for Therapeutic Innovation)

Vojtech Kvita

Vojtech Kvita

CVO | NextPV Services s.r.o.

Sara Lazzarin

Sara Lazzarin

Global Head of Pharmacovigilance Unit | OPIS s.r.l.

Hervé Le Louët

Hervé Le Louët

Head of PV policy intelligence strategy | Takeda, President of CIOMS, Past CEO of the UMC, Past President of ISOP

Maddalena Lino

Maddalena Lino

Neurologist, Safety Risk Lead Director | Pfizer

Calin A. Lungu

Calin A. Lungu

DDCS S.A., CEO

Arduino Mangoni

Arduino Mangoni

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

Zeljana Margan Koletic

Zeljana Margan Koletic

Croatian PRAC Alternate Member, Head of Pharmacovigilance Dept (HALMED)

Niteeka Maroo

Niteeka Maroo

Head Pharmacovigilance | Piramal Group-India

Larissa Mege

Larissa Mege

Global Safety Officer, Sanofi Rare Diseases, Speciality Care Business Unit

Nicholas Moore

Nicholas Moore

Emeritus Professor, specialist in Cardiology and Pharmacology | University of Bordeaux

Charalampos Nakos

Charalampos Nakos

EU-QPPV | Drug Safety Solutions

Helen Byomire Ndagije

Helen Byomire Ndagije

Product Safety Director | The National Drug Authority in Uganda, President of the ISoP Africa chapter

Eriko Ogura

Eriko Ogura

Global Head of Drug Safety | Shionogy

Nuccia Oneto

Nuccia Oneto

Patient Oriented Programs Governance Lead | Novartis Farma S.p.A.

Maria Beatrice Panico

Maria Beatrice Panico

Principal consultant | Scendea

Susana Perez-Gutthann

Susana Perez-Gutthann

Vice President, Global Head Epidemiology | RTI International

Andrea Pieri

Andrea Pieri

Business Development Director | Pharma D&S

Elena Prokofyeva

Elena Prokofyeva

Head of the Drug Safety Team, R&D Department | DG PRE, FAMHP

Lembit Rägo

Lembit Rägo

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

Hadir Rostom

Hadir Rostom

Lecturer, MSA university & President of ISoP Egypt Chapter

Annette Rudolph

Annette Rudolph

Pharmacovigilance scientist | Uppsala Monitoring Centre

Jennifer Stevenson

Jennifer Stevenson

Consultant Pharmacist for Older People, Guy’s and St Thomas’ NHS Foundation Trust

Sophia Trantza

Sophia Trantza

MSc, MSc PV, Senior pharmacovigilance expert

Gianluca Trifirò

Gianluca Trifirò

Professore Ordinario di Farmacologia – Dipartimento di Diagnostica e Sanità Pubblica | Università di Verona

Anne Ruth van Troostenburg De Bruyn

Anne Ruth van Troostenburg De Bruyn

EU QPPV and VP Pharmacovigilance & Epidemiology | Gilead Sciences

Monica Da Luz Carvalho Soares

Monica Da Luz Carvalho Soares

Health Regulatory Expert, Pharmacovigilance Adviser | Brazilian Health Surveillance Agency ANVISA

Michael Von Forstner

Michael Von Forstner

Global Head of Clinical Safety and Pharmacovigilance | Biogen

Qun Ying Yue

Qun Ying Yue

Associate professor Senior Pharmacovigilance Expert | Uppsala Monitoring Center

Ivona Bahnik Bisevac

Ivona Bahnik Bisevac

Director Benefit-Risk Management | PrimeVigilance

Sponsors & Media Partners EUPV2023

Clinpharma

Sponsor
Clinpharma

iVigee

Sponsor
iVigee

MedCommunications

Sponsor
MedCommunications

Opis

Sponsor
Opis

Pharma D&S

Sponsor
Pharma D&S

PHV Latam

Sponsor
PHV Latam

PrimeVigilance

Sponsor
PrimeVigilance

ProductLife Group

Sponsor
ProductLife Group

MedTech Outlook

Media Partner
MedTech Outlook

Pharma Tech Outlook

Media Partner
Pharma Tech Outlook

Sage

Media Partner
Sage

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

The European Pharmacovigilance Congress 2023 will be a mixed event:

Step 1

On November 27-28 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 December 1! 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 Hilton Garden Inn Milan North.

All the past editions

Download brochures from previous editions of European Pharmacovigilance Congress 2023

Sign up for the conference

Face to Face (01/12/23)
Early bird until 27/10/2023*

650€
700€

Virtual (27-28/11/23)
Early bird until 27/10/2023*

725€
800€

Virtual + Face to Face (27-28/11/23 e 01/12/23)
Early bird until 27/10/2023*

985€
1200€

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

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