European Pharmacovigilance Congress 2024

18-19 Novembre 2024
Online
English
 
22 Novembre 2024
Face to face in Milan
English
 

Panoramica della conferenza

The European Pharmacovigilance Congress, organized by Pharma Education Center, is recognized as one of the most important and appreciated global pharmacovigilance conferences.
EUPV congress is proud to have high quality scientific content as its main characteristic which has attracted growing interest from speakers, sponsors and participants from all over the world.
The EUPV congress gathers PV professionals at all career levels, including key decision makers (e.g. VPs, Executives and Directors,) interested in the always evolving pharmacovigilance world and its new trends, since they are always looking for new ideas to implement more efficient and effective strategies and tools for their departments.
To further improve the value of the congress and continuously make it more and more interesting by bringing new ideas and scientific contents, this year the Scientific Board has been further widened with the addition of new PV key opinion leaders who need no introduction since their knowledge and skills are world class.
EUPV congress is the forum where all PV stakeholders from all over the world meet and exchange ideas.

Format del congresso

The European Pharmacovigilance Congress will be a mixed event!

18-19 November | Virtual 9 am- 6 pm
21 November | APERITIF TIME, NH Milano Congress Centre 6 pm – 9 pm
22 November | Face to face, NH Milano Congress Center 9.30 am – 5 pm

APERITIF TIME – November 21 from 6 to 9 pm – NH Milano Congress
Reserve your place to meet and network with your colleagues and experts!

This year the congress will include:
25 Topics
11 virtual & face to face parallel sessions
25 interactives round tables
2 face to face workshops
2 LECTIO Magistralis

Perchè partecipare?

  • 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

A chi è 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

TOPICS 2024 IN PROGRESS

THEMATIC SESSIONS

18/11 – Virtual
– BIOLOGICAL BASIS OF ADVERSE REACTIONS WITH FOCUS ON SCARS
– IMMUNOLOGICAL ADVERSE REACTIONS
– SIGNAL DETECTION
– RISK MANAGEMENT
– COMMUNICATING SAFETY INFORMATION IN THE DIGITAL ERA

19/11  – Virtual
– AUTHORITIES’ ASSESSMENT OF PV INFORMATION
– REAL WORD DATA & REAL WORD EVIDENCE
– MANUFACTURING & PV INTERFACES
– DRUG SAFETY IN MARKETING AUTHORIZATION APPLICATIONS
– EVOLVING LANDSCAPE OF ELECTRONIC SAFETY DATA IN PV
– NON-EU PV REQUIREMENTS

22/11 – Milan
– EVOLVING PHARMACOVIGILANCE STRATEGIES
– MAIN GLOBAL AND LOCAL PV UPDATES
– PRACTICAL EXPERIENCE OF APPLYING ARTIFICIAL INTELLIGENCE IN PV
– AUDIT &INSPECTIONS

and more parallel sessions coming …

27 November 2023 - VIRTUAL / Agenda 2024 in progress


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, Senior Manager, Risk Management Plans (RMP) Team Leader | Teva
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 / Agenda 2024 in progress


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 Pharmacovigilance | 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 / Agenda 2024 in progress


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 2024


Andrew Bate

Andrew Bate

VP, Head of Safety Innovation & Analytics | GSK

Glyn Belcher

Glyn Belcher

CEO | PV Consultancy Ltd

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. Past Head of Global Pharmacovigilance and EU-UK QPPV at Chiesi Farmaceutici S.p.A.

Mircea Ciuca

Mircea Ciuca

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

Giovanni Furlan

Giovanni Furlan

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

Calin Lungu

Calin 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, Chairperson for EUPV Congress

Speakers 2024 - In Progress...


Mayssa AbouGhannam

Mayssa AbouGhannam

Country Safety Team Lead, Saudi Arabia, Gulf, Pakistan, Afghanistan | Johnson & Johnson

Fazil Afzal

Fazil Afzal

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

Klaudija Marijanovic Barac

Klaudija Marijanovic Barac

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

Andrew Bate

Andrew Bate

VP Safety Innovation & Analytics | GSK

Glyn Belcher

Glyn Belcher

CEO | PV Consultancy Ltd

John -Joseph Borg

John -Joseph Borg

Director Post-Licensing | Malta Medicines Authority

Margherita D'Antuono

Margherita D'Antuono

EU-UK QPPV| Piramal Critical Care

Anne De Groot

Anne De Groot

CEO/CSO and Director | Epivax

Roxana Dondera

Roxana Dondera

Head of Pharmacovigilance and Risk Management Unit | National Agency for Medicine and Medical Devices of Romania

Iva Galic

Iva Galic

Pharmacovigilance Inspector Expert | HALMED

Ilaria Grisoni

Ilaria Grisoni

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

Terenzio Ignoni

Terenzio Ignoni

SVP Quality and CMC | Gain Therapeutics

Vibha Jawa

Vibha Jawa

Executive director | Bristol Myers Squibb

Calin Lungu

Calin Lungu

DDCS S.A., CEO

Arduino Mangoni

Arduino Mangoni

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

Zeljana Margan Koletic

Zeljana Margan Koletic

Senior Manager, Risk Management Plans (RMP) Team Leader | Teva

Robert Massouh

Robert Massouh

Head of (PV) Risk Management and Benefit Risk Evaluation | Gsk

Nicholas Moore

Nicholas Moore

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

Iva Novak

Iva Novak

Head of European Pharmacovigilance and EU QPPV | Teva

Maria Beatrice Panico

Maria Beatrice Panico

Principal Consultant | Scendea

Georgios	Papazisis

Georgios Papazisis

Professor of Clinical Pharmacology; Medical Director, Clinical Research Unit | School of Medicine, Aristotle University of Thessaloniki

Lembit Rägo

Lembit Rägo

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

Amy	Rosemberg

Amy Rosemberg

Senior Director and Consultant, Immunology | EpiVax, Inc

Geeta Shanbhag

Geeta Shanbhag

VP Pharmacovigilance and Medico- Regulatory Affairs | Ipca Laboratories Ltd

Sofia Trantza

Sofia Trantza

Senior Pharmacovigilance Expert , PRAC member Greece

Chia Yu Chu

Chia Yu Chu

Prof. Department of Dermatology | National Taiwan University

Sponsors & Media Partners EUPV2023 - SPONSORS 2024 IN PROGRESS

Diventa 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.

Sede del congresso

The European Pharmacovigilance Congress 2024 will be a mixed event:

Step 1

On November 18-19 the event will be VIRTUAL to grant you the possibility of joining the conference even from your office or home, wherever you may be. We have organized a true virtual location, a space where you will be able to:

  • Follow the live streaming of the congress, listen to experts and opinion makers and be informed about latest trends and technological breakthroughs in drug safety
  • Visit the VIRTUAL EXHIBITION AREA and all the stands of our sponsors
  • Join Q&A times and round tables to discuss the current hot topics in the field
  • Chat with our sponsors and learn about new technologies and services to ease your daily work and increase the performance

Step 2

Let’s finally meet face to face in Milan on November 22! A great chance to meet in person the EUPV experts and colleagues. A great chance to meet in person the EUPV experts and colleagues. The conference will be hosted in the wonderful spaces of NH Milano Congress Centre, in Assago, Milan.

Edizioni precedenti

Scarica le brochure delle precedenti edizioni di European Pharmacovigilance Congress 2024

Iscriviti alla conferenza

Face to Face (22/11/24)
Early bird fino al 18/10/2024*

400€
500€

Virtual (18-19/11/24)
Early bird fino al 18/10/2024*

600€
650€

Virtual + Face to Face (18-19/11/24 e 22/11/24)
Early bird fino al 18/10/2024*

750€
950€

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

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