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    • Nov 28
    • 2025

28 November 2025, 09:35 | 11:00

SESSION 17 - OVERCOMING CHALLENGES AND PRIORITIZING VALUE INTHE EVOLVING PV LANDSACAPE

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Speakers
JAN PETRACEK
ANDREW BATE
KENDAL HARRISON
BARBARA DE BERNARDI
FELIX ARELLANO
VALERIA DI CLEMENTE
ELENA PROKOFYEVA
LISA STAGI
Introduction by the Chairperson
  • November, Friday 28 | 09:35 - 09:40
JAN PETRACEK
Does it make sense? High versus low value work in PV
  • November, Friday 28 | 09:40 - 09:50
ANDREW BATE
Strategic Vigilance in a Rapidly Evolving World
  • November, Friday 28 | 09:50 - 10:00
KENDAL HARRISON
Challenges and innovations in pharmacovigilance and signal management: from the COVID-19 pandemic experience to the future
  • November, Friday 28 | 10:00 - 10:10
BARBARA DE BERNARDI
Round Table
  • November, Friday 28 | 10:10 - 11:00
JAN PETRACEK
ANDREW BATE
KENDAL HARRISON
BARBARA DE BERNARDI
FELIX ARELLANO
VALERIA DI CLEMENTE
ELENA PROKOFYEVA
LISA STAGI

28 November 2025, 11:30 | 13:00

SESSION 19: PARALLEL WORKSHOP: Pharmacovigilance in Transition: Adapting toGlobal and Regional Regulatory Change

  • PARALLEL ROOM
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Speakers
ELENA ALCARAZ
MERCEDINA DEL PAPA
SARA VODANOVIC
Topic 1 - The New EU PV Regulation 2025/1466: Impact on Pharmacovigilance Operations under Implementing Regulation 520/2012 – challenges and opportunities
  • November, Friday 28 | 11:30 - 12:05
ELENA ALCARAZ
MERCEDINA DEL PAPA
Topic 2 - Effective Regulatory Intelligence for Navigating Global PV Regulation and Implementation
  • November, Friday 28 | 12:05 - 13:00
SARA VODANOVIC

28 November 2025, 11:30 | 13:15

SESSION 18 - PERSONALIZED PV

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Speakers
FELIX ARELLANO
GIUSEPPE CURIGLIANO
RAJAT MOHINDRA
ADRIAN ROTH
SABINE FUERST-RECKTENWALD
Introduction by the Chairperson
  • November, Friday 28 | 11:30 - 11:35
FELIX ARELLANO
Precision oncology in the era of molecular tumor board
  • November, Friday 28 | 11:35 - 11:50
GIUSEPPE CURIGLIANO
Applying advanced analytics and multiomic biomarker approaches in Precision Safety
  • November, Friday 28 | 11:50 - 12:05
RAJAT MOHINDRA
Novel human cell models to characterize toxicity
  • November, Friday 28 | 12:05 - 12:20
ADRIAN ROTH
Precision Pharmacovigilance in Pediatrics: rethinking Safety Extrapolation with ICH E11A
  • November, Friday 28 | 12:20 - 12:35
SABINE FUERST-RECKTENWALD
Round Table
  • November, Friday 28 | 12:35 - 13:00
FELIX ARELLANO
GIUSEPPE CURIGLIANO
RAJAT MOHINDRA
ADRIAN ROTH
SABINE FUERST-RECKTENWALD

28 November 2025, 14:15 | 15:20

SESSION 20 - PRAC AND OTHER EUROPEAN AUTHORITY PROCESSES FORMONITORING THE BENEFIT RISK OF DRUGS

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Speakers
SOPHIA TRANTZA
PETAR MAS
PILAR RAYÓN
ANA SOFIA MARTINS
LINA SEIBOKIENE
MARKO KORENJAK
Introduction by the Chairperson
  • November, Friday 28 | 14:15 - 14:25
SOPHIA TRANTZA
Round Table
  • November, Friday 28 | 14:25 - 15:20
SOPHIA TRANTZA
PETAR MAS
PILAR RAYÓN
ANA SOFIA MARTINS
LINA SEIBOKIENE
MARKO KORENJAK

SESSION 21 - (PARALLEL) NEW SKILLS NEEDED IN PV

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Speakers
GIAN NICOLA CASTIGLIONE
JAN PETRACEK
GIOVANNI FURLAN
Introduction by the Chairperson
  • November, Friday 28 | 14:15 - 14:20
GIAN NICOLA CASTIGLIONE
Skillset of Pharmacovigilance AI Supervisors
  • November, Friday 28 | 14:20 - 14:40
JAN PETRACEK
Human-AI collaboration in PV
  • November, Friday 28 | 14:40 - 15:00
GABRIÈLE PIATON-BREDA
Panel discussion
  • November, Friday 28 | 15:00 - 15:20
GIAN NICOLA CASTIGLIONE
JAN PETRACEK
GIOVANNI FURLAN
GABRIÈLE PIATON-BREDA

28 November 2025, 15:45 | 17:40

SESSION 22 - PRE & POST MARKETING AUDITS & INSPECTIONS

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Speakers
VALENTINA MANCINI
ELENA GIOVANI
ANA MARIA VELASCO CALLE
NATASHA MIHAJLOVIC
CALIN LUNGU
ALBERTO GRAMACCIOLI
Introduction by the Chairperson
  • November, Friday 28 | 15:45 - 15:50
VALENTINA MANCINI
PV Inspections: trends and updates
  • November, Friday 28 | 15:50 - 16:10
ELENA GIOVANI
Preparation, implementation and results of pharmacovigilance inspection plan
  • November, Friday 28 | 16:10 - 16:30
ANA MARIA VELASCO CALLE
PV Auditing on the brink: missed beats, blurred lines, and the AI wave ahead
  • November, Friday 28 | 16:30 - 16:50
NATASHA MIHAJLOVIC
Audit of vendors and service providers
  • November, Friday 28 | 16:50 - 17:10
CALIN LUNGU
Round Table
  • November, Friday 28 | 17:10 - 17:40
VALENTINA MANCINI
ELENA GIOVANI
ANA MARIA VELASCO CALLE
NATASHA MIHAJLOVIC
CALIN LUNGU
ALBERTO GRAMACCIOLI
CLOSURE OF THE CONGRESS
  • November, Friday 28 | 17:40

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