European Pharmacovigilance Congress 2025

09.00 – Marco Sardella, Chief Pharmacovigilance Officer & EU QPPV | ADIENNE Pharma & Biotech

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

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

09.20 – Severe cutaneous adverse drug reactions: epidemiological and pathophysiological considerations
Arduino Mangoni, Strategic Professor in Clinical Pharmacology | Flinders University, Senior Consultant in Clinical Pharmacology and General Medicine, Adelaide, Australia

09.40 – Understanding the Pathophysiological Mechanisms of SCARS: A Call for Harmonized Definitions and CIOMS Recommendations
Chia-Yu Chu, Prof. Department of Dermatology | National Taiwan University

10.00 – Biological basis of adverse drug reactions affecting the central nervous system
Georgios Papazisis, Professor of Clinical Pharmacology; Medical Director, Clinical Research Unit, School of Medicine | Aristotle University of Thessaloniki, Greece

10.20 – Round Table and Q&A Time
Moderator: G. Furlan
Panelists: A. Mangoni; C. Y. Chu; G. Papazisis

10.50 – Coffee Break & networking

11.10 – Chairperson – Mattia Calissano, Head of Pharmacovigilance | Orchard Therapeutics

11.15 – Assessing the global ,regional and personal immunogenity risk of biologic therapy
Anne de Groot, CEO/CSO and Director | EpiVax

11.35 – Mitigation strategies for immunogenicity of biological therapeutic: Sometimes more is Better
Amy Rosenberg, Senior Director and Consultant, Immunology | EpiVax, Inc

11.55 – Round Table
Moderator: M. Calissano
Panelists: A. De Groot; A. Rosenberg

12.30 – LUNCH

11.10 – Chairperson – Paola Kruger, Head of Expert Patient | EUPATI (Europe an Patient’s Academy for Therapeutic Innovation)

11.20 – Safety Communication aspects of the ConcePTION Mobile App
Amalia Alexe, PV Policy and Liaison Lead, QPPV Office | Novartis

11.40 – Digital Pathways to Patient Safety: Enhancing Pharmacovigilance Communication
Marko Korenjac, President of the European Liver Patients’ Association

12.00 – Panel Discussion

12.30 – LUNCH

1.45 – Chairperson – Maddalena Lino, Safety Risk Lead Senior Director | Pfizer

1.50 – Multi-modal data science for signal detection – What are the Challenges? What are the Opportunities
Natsiavas Pantelis, Researcher (Grade C) | Institute of Applied Biosciences of Centre for Research and Technology Hellas (INAB|CERTH), Thessaloniki, Greece

2.10 – What is the role of Big Data and Artificial Intelligence in Pharmacovigilance?
Gianluca Trifirò | Full Professor of Pharmacology Department of Diagnostics and Public Health | University of Verona

2.30 – Insights into recent safety observations associated with CART cell therapies
Vibha Jawa | Executive Director for Biotherapeutics Bioanalysis in clinical Pharmacology, Pharmacometricsand Bioanalysis (NDB) organization | Bristol Myers Squibb

2.50 – Round Table and Q&A Time:
Moderator: M. Lino
Panelists: V. Jawa, N. Pantelis, G. Trifirò, F. De Gregorio | Shionogi Europe

3.20 – Coffee Break & Networking

2.30 – Chairperson – Margherita D’Antuono, EU-UK QPPV | Piramal Critical Care

2.35 – Current pharmacovigilance & QPPV requirements in SAUDI ARABIA
Ahmed Diaa Eldin, CEO | Baupharma

3.00 – Q&A Time

3.20 – Coffee Break & Networking

3.40 – Chairperson – Glyn Belcher, CEO | PV Consultancy Ltd.

3.45 – Proposing Benefit-Risk Management Plans as the evolution of RMPs
Robert Massouh, Head of (PV) Risk Management and Benefit Risk Evaluation | Gsk

4.05 – Pregnancy prevention – RMM effectiveness evaluation experience
Klaudija Marijanovic Barac, Sr. Director, EU&UK QPPV Deputy, Head Periodic Reports and Risk Management Unit | TEVA

4.25 – Pharmaceuticals in the environment: from Echopharmacovigilance to neurobehavioral studieson zebrafish
Giovanna Paolone, Associate Professor of Pharmacology – Department of Diagnostics and Public Health | University of Verona

4.45 – Round Table and Q&A Time
Moderator: G. Belcher
Panelists: R. Massouh; K.M. Barac; G. Paolone

3.40 – Chairperson – Hrvoje Macek, VP, Medical & Scientific Affairs, an Patient’s Academy for Therapeutic Innovation

3.45 – Design, implementation, and evaluation of risk minimization measures
Michael Von Forstner, Head of Safety Science | Sobi

4.05 – aRMM in pregnancy risk mitigation
Iva Kuliš, Principal Coordinator for Information in PV and Rational Pharmacotherapy, Dept for PV and Rational Pharmacotherapy| HALMED

4.25 – Challenges of benefit-risk assessment – when to trigger a referral procedure?
Barbara Kovačić Bytyqi, Head of Departement for Pharmacovigilance and Rational Pharmacotherapy | HALMED

4.45 – Round Table and Q&A Time
Moderator: H. Macek
Panelists: B. Kovačić Bytyqi; I. Kuliš; M. Von Forstner

5.15 – Marco Sardella, Chief Pharmacovigilance Officer & EU QPPV | ADIENNE Pharma & Biotech

5.20 – What are the cardiovascular risks of NSAIDs?
Nicholas Moore, Emeritus Professor of Clinical Pharmacology | University of Bordeaux

5.45 – Q&A Time

6.00 – Closure of the Day

09.00 – Marco Sardella, Chief Pharmacovigilance Officer & EU QPPV | ADIENNE Pharma & Biotech

09.10 – Chairperson – Mircea Ciuca, Global Therapeutic Area Head in Global Clinical Safety and Pharmacovigilance

09.15 – PSUR assessment by The Malta Medicines Authority
John Joseph Borg | Director Post-Licensing | Malta
Medicines Authority

09.35 – Challenges in risk-benefit assessment
Roxana Dondera | Head of Pharmacovigilance and Risk Management Unit | National Agency for Medicine and Medical Devices of Romania

09.55 – Risk Management Plan for Radiopharmaceuticals
Sofia Trantza | Senior Pharmacovigilance Expert | PRAC member Greece

10.15 – Round Table and Q&A Time
Moderator: M. Ciuca
Panelists: J.J. Borg; R. Dondera; S. Trantza

10.45 – Coffee Break & networking

11.05 – Chairperson – Lembit Rago, Secretary-General | Council for International Organizations of Medical Sciences (CIOMS)

11.10 – RWD and RWE in regulatory decision making: CIOMS WG XIII Report
Lembit Rago, Secretary-General |Council for International Organizations of Medical Sciences (CIOMS)

11.30 – From RWD to RWE – Teva experience
Željana Margan Koletić, Senior Manager, Risk Management Plans (RMP) Team Leader | Teva

11.50 – Analysis of the nature and contributory factors of medication safety incidents following Hospital disharge using National Reporting and Learning System (NRLS) data from England and Wales: a multi-method study
Fatema Alqenae, Pharmacist | Kuwait – Winner EUPV 2023 Award

12.10 – Round Table and Q&A Time
Moderator: L. Rago
Panelists: Z.M. Koletic; F. Alqenae

12.30 – LUNCH

11.05 – Chairperson – Jan Petracek, CEO | iVigee

11.10 – Evolving Landscape of electronic safe data in PV in the EU
Calin Lungu | DDCS S.A., CEO

11.40 – Panel Discussion

12.10 – LUNCH

1.45 – Chairperson – Valentina Mancini, Senior Director Pharmacovigilance QPPV | Shionogi Europe

1.50 – Looking for triggers: from the small signal to the bigger picture
Domenico Di Giorgio, Head of Inspection & Certification Department and of the Pharmaceutical Crime Counteracting Office at the Italian Medicines Agency | AIFA

2.10 – NCE Early Development and Manufacturing : Idiosyncratic Reactions Risk Mitigation in Post Marketing
Terenzio Ignoni, SVP Quality and CMC | Gain Therapeutics

2.30 – Impact of Manufacturing Changes on Pharmacovigilance for Biological Products
Dina B. Tresnan, Disease Area Cluster Lead – Immunolo-Oncology; Safety Surveillance and Risk Management, Worldwide Safety | Pfizer

2.50 – Round Table
Moderator: V. Mancini
Panelists: D. Di Giorgio; T. Ignoni; D. Tresnan

1.45 – Chairperson – Mircea Ciuca, Global Therapeutic Area Head in Global Clinical Safety and Pharmacovigilance

1.50 – Safety in clinical trials under the clinical trial regulation: state of play and first experience
Elena Prokofyeva, Head of safety in clinical trials unit, DG Post, FAMHP

2.10 – From SUSAR to risk via signal management
Mircea Ciuca | Global Therapeutic Area Head in Global Clinical Safety and Pharmacovigilance

2.30/3 – Q&A Time

3.20 – Coffee Break

3.40 – Chairperson – Marco Sardella, Chief Pharmacovigilance Officer & EU QPPV | ADIENNE Pharma & Biotech

3.45 – Adverse Event Grouping Strategies During Clinical Trial Analysis
Scott Proestel | VP, Medical Informatics | Medpace, Inc., former Senior Medical Officer | FDA

4.05 – 2024 CIOMS guideline on MedDRA Labeling grouping and experience with ADR groupings for labeling – a personal perspective
Aoibhinn McDonnell | Safety Evaluation and Risk Management (SERM) Senior Director | GSK, UK

4.25 – Round Table
Moderator: M. Sardella
Panelists: S. Proestel; A. McDonnell

3.40 – Chairperson – Mattia Calissano, Head of Pharmacovigilance | Orchard Therapeutics

3.45 – UK Pharmacovigilance Requirements: A Regulator’s Perspective
Fazil Afzal, Medical Assessor at Medicines and Healthcare products Regulatory Agency (tbc)

4.05 – Elevating Pharmacovigilance in Saudi Arabia beyond Benchmarks to Innovation
Mayssa Abou Ghannam, Country Safety Team Lead, Saudi Arabia, Gulf, Pakistan, Afghanistan | Jansenn

4.25 – Comparison of RMM Approaches across EU, Japan and US
Robert Massouh, Head of (PV) Risk Management and Benefit Risk Evaluation | Gsk

4.45 – Regulatory Requirements of Pharmacovigilance in India
Geeta Shanbhag, VP Pharmacovigilance and MedicoRegulatory Affairs | Ipca Laboratories Ltd.

5.05 – Round Table
Moderator: M. Calissano
Panelists: F. Afzal; M. AbouGhannam; R. Massouh; G. Shanbhag

5.30 – Marco Sardella, Chief Pharmacovigilance Officer & EU QPPV | ADIENNE Pharma & Biotech

5.30 – Pharmacovigilance – Where have we come from and where are we going?
Glyn Belcher | Senior Scientific Advisor | EUPV Congress

6.00 Closure of the Day

09.20 – Marco Sardella, Chief Pharmacovigilance Officer & EU QPPV | ADIENNE Pharma & Biotech

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

Panel Discussion:
Felix Arellano, Senior Vice President and the Global Head of Safety & Risk Management | Roche
Andrew Bate, VP Safety Innovation & Analytics | GSK
Marcin Kruk, Drug Safety Regional Head Europe , Africa, Middle East, Worlwide Medical & Safety | Pfizer Inc.
Sofia Trantza, Senior Pharmacovigilance Expert | PRAC Member Greece

10.40 – Coffee Break

11.10 – Chairperson – Calin Lungu, CEO | DDCS S.A.

11.15 – ICH E6 (R3)
Fabrizio Galliccia, Head of GCP Inspectorate and GCP Senior Inspector

11.35 – Global and Local PV Regulatory Intelligence with AI: New Collection, Assessment, and Interpretation
Marcela Fialova, Chief Operating Officer | iVigee

11.55 – Global and Local PV requirements – Establishing and maintaining a compliant global PV system
Ilaria Grisoni, Exec. Dir., Head of EU/International PV & Office of QPPV, EEA QPPV | Jazz Pharmaceuticals

12.15 – Round Table
Moderator: C. Lungu
Panelists: F. Gallicia; I. Grisoni; M. Fialova; D. Marcozzi | Fidiapharma

12.40 – Award Ceremony for the selected PV article published in Therapeutic Advanced in Drug Safety 2023

12.50 – Lunch & Networking

INTERACTIVE WORKSHOP

Topic 1
The Latest revisions of GVP guidelines on Risk Minimisation Measures and Definition – let’s navigate together through the updates
Mercedina del Papa, Strategic Advisor, EU QPPV | Prime Vigilance

Topic 2
Pharmacovigilance between MA application and approval – challenges for sponsors transforming to MAH
Natalia Kalousova Kocankova, Senior Strategic Advisor, EU QPPV Office Director | PrimeVigilance

2.00 – Chairperson – Andrew Bate, VP Safety Innovation & Analytics | GSK

2.05 – MHRA experience in applications for AI in Pharmacovigilance
Phil Tregunno, Deputy Director, Patient Safety Monitoring, Safety and Surveillance | MHRA

2.25 – Revolutionize Signal management with AI
Maurizio Sessa, Associate Professor of Pharmacoepidemiology | University of Copenhagen

2.45 – AI in Pharmacovigilance at the Swedish Medical products Agency
Gabriel Westman, Head of Artificial Intelligence | Swedish Medical Products Agency

3.05 – Round Table
Moderator: A. Bate
Panelists: P. Tregunno; M. Sessa; V. Mancini | Shionogi Europe

3.30 – Coffee Break

4.00 – Chairperson – 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 | Chiesi Farmaceutici S.p.A.

4.05 – Elena Giovani, Head of the GVP Inspection Office | AIFA

4.25 – Aurora María Rojo Sanchís, Head of GCP and GVP Inspectorate Spanish Agency of Medicines and Medical Devices (AEMPS)

4.45 – Iva Novak, Head of European Pharmacovigilance and EU QPPV | Teva

5.05 – Round Table
Moderator: G.N. Catiglione
Panelists: E. Giovani; M. D’Antuono | Piramal , I. Novak; A.M. Rojo Sanchís

5.30 – Closure of the Congress