European Pharmacovigilance Congress 2024

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

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

09.40 – Chia-Yu Chu | Prof. Department of Dermatology | National Taiwan University

10.00 – 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 – Chair – Mattia Calissano | Head of Pharmacovigilance | Orchard Therapeutics

11.15 – Anne de Groot | CEO/CSO and Director | EpiVax

11.35 – 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 – Chair – 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
Amanda Alexe | PV Policy and Liaison Lead, QPPV Office | Novartis

11.40 – Marco Greco, European Patients’ Forum President (EPF) – TBC

12.00 – Panel Discussion

12.30 – LUNCH

1.45 – Chair – Maddalena Lino, Safety Risk Lead 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: N. Pantelis; G. Trifirò; V. Jawa

3.20 – Coffee Break & Networking

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

3.45 – Michael Von Forstner, Head of Safety Science | Sobi

4.05 – From assessment of ADR reports to risk minimisation measures (RMM) implementation
Morana Pavičić, Principal Coordinator of the National ADR Centre and Pharmacoepidemiology Pharmacovigilance and Rational Pharmacotherapy Departement | 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; M. Pavičić; M. Von Forstner

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

5.20 – 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 – Chair – Mircea Ciuca, Global Therapeutic Area Head in Global Clinical Safety and Pharmacovigilance

09.15 – John Joseph Borg | Director Post-Licensing | Malta
Medicines Authority

09.35 – Roxana Dondera | Head of Pharmacovigilance and Risk Management Unit | National Agency for Medicine and Medical Devices of Romania

09.55 – 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 – Chair – 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 – Chair – Jan Petracek, CEO | iVigee

11.10 – Calin Lungu | DDCS S.A., CEO

11.40 – TBD

12.00 – Panel Discussion

12.30 – LUNCH

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

1.50 – AIFA Representative (tbc)

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: TBC
Panelists: AIFA Representative (tbc); T. Ignoni; D. Tresnan; V. Mancini

1.45 – Chair – TBD

1.50 – A Fresh Approach to Development Safety Update Reports/Annual Safety Reports
Maria Beatrice Panico, Principal Consultant | Scendea

2.10 – In Progress…

3.20 – Coffee Break

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

3.45 – Adverse Event Grouping Strategies During Clinical Trial Analysis
Scott Proestel | Senior Medical Officer | FDA

4.05 – Aoibhinn McDonnell, Safety Risk Lead, Director, Safety Surveillance and Risk Management | Pfizer

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

3.40 – Chair – 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 | Johnson & Johnson

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 – Chair of the Session
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 – Chair of the Session
Calin Lungu | DDCS S.A., CEO

11.15 – AIFA Representative (tbc)

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

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

12.15 – Round Table
Moderator: C. Lungu
Panelists: AIFA Representative; I. Grisoni; M. Fialova; D. Marcozzi

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

12.50 – Lunch & Networking

2.00 – Chair – 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

3.30 – Coffee Break

4.00 – Chair – 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 – AIFA Representative (tbc)

4.25 – Mônica da Luz Carvalho | Health Regulatory Expert, Pharmacovigilance Adviser | Brazilian Health Surveillance Agency (ANVISA)

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

5.05 – Round Table
Moderator: G.N. Catiglione
Panelists: AIFA Representative; M. D’Antuono; I. Novak; m. De Luz Carvalho

5.30 – Closure of the Congress