Day 1:

• Pharmacovigilance (PV) regulation and guidelines
• Role and responsibilities of the Qualified Person for Pharmacovigilance (QPPV) and the Pharmacovigilance System Master File (PSMF)
• Handling Individual Case Safety Reports (ICSR), MedDRA coding, practical case scenarios
• Product safety information
• Workshop: ICSR case processing in groups
• Recap of the day and questions

Day 2: 

• Summary of day one
• Safety in clinical trials, medical devices, and combination products
• Periodic Safety Update Reports (PSUR)
• Signal management and risk minimization strategies
• PV interface: Cross-functional alignment with key functions
• PV agreements
• PV  inspections from the regulatory Authority's perspective & industry preparation for PV inspections
• Introduction to artificial intelligence in PV
• Recap of the day and questions

Welcome & Introduction
Lisbeth Andersen / Pfizer Corporation Austria

Pharmacovigilance (PV) Regulations and Guidelines
Dr. Jan Neuhauser / AGES 
This session provides an overview of the European and Austrian pharmacovigilance regulatory framework, key legislation, and current guidelines governing medicinal product safety monitoring.

Role and Responsibilities of the Qualified Person for Pharmacovigilance (QPPV) and the Pharmacovigilance System Master File (PSMF)
Dr. Martina Friedl / Gebro Pharma GmbH
This session focuses on the role of the QPPV and the importance of the PSMF within a company's pharmacovigilance system.
Key Topics
•    Establishment and maintenance of the Marketing Authorisation Holder’s Pharmacovigilance System
•    Structure and content of the Pharmacovigilance System Master File (PSMF)
•    Oversight of the PV quality system
•    Continuous monitoring of the safety profile of medicinal products
•    Role of the QPPV as the single pharmacovigilance contact point for competent authorities on a 24/7 basis

Handling Individual Case Safety Reports (ICSR), MedDRA Coding and Practical Case Scenarios
Lisbeth Andersen / Pfizer Corporation Austria
This session introduces participants to the principles of ICSR processing, including regulatory definitions, MedDRA coding principles, and practical case examples. Participants will learn how to classify product safety information and understand the complete lifecycle of an ICSR from initial receipt through regulatory submission.
Session Overview
•    Introduction to ICSR processing principles
•    Regulatory definitions and reporting requirements
•    MedDRA coding principles and best practices
•    Assessment of practical case scenarios

Product Safety Information
Sabine Rußler / AOP Orphan Pharmaceuticals GmbH
This session provides an overview of the key documents, tools, and regulatory procedures used to communicate safety-related information about medicinal products to healthcare professionals and patients.
Key Topics
•    Risk communication through the Summary of Product Characteristics (SmPC): content and location of safety information
•    Sources of new safety-relevant information and their regulatory pathways
•    Implementation of new safety information
•    Safety-related variations
•    Direct Healthcare Professional Communications (DHPCs) and Educational Materials
•    Additional Monitoring and its implicationst.

Workshop: ICSR Case Processing in Groups
Lisbeth Andersen / Pfizer Corporation Austria
A practical workshop where participants work in small groups on real-life case scenarios to apply the knowledge acquired during the ICSR session.
Objectives
•    Evaluate and classify safety information
•    Practice MedDRA coding
•    Determine reportability and reporting timelines
•    Discuss case assessment approaches within a group setting

Recap of the Day, Q&A & Summary
Lisbeth Andersen / Pfizer Corporation Austria

Summary of Day One
Lisbeth Andersen / Pfizer Corporation Austria

The PHARMIG Network PV
Michael Kunze / PHARMIG
Overview of the PHARMIG Pharmacovigilance Network and its role in facilitating collaboration and knowledge exchange within the PV community.

Introduction to Safety in Clinical Trials, Performance Studies, and Medical Device / Combination Product Clinical Investigations
Marianne Kaniak / Amgen Austria GmbH
Introduction to safety responsibilities related to Investigational Medicinal Products (IMPs), In Vitro Diagnostics (IVDs), Medical Devices (MDs), and Combination Products, including the applicable regulatory requirements

Periodic Safety Update Reports (PSURs)
Dr. Jan Neuhauser / AGES – Austrian Agency for Health and Food Safety
This periodic re-evaluation of the benefit-risk ratio of medicinal products represents one of the fundamental pillars of drug monitoring. The procedure is presented using practical examples and relevant guidelines are discussed.

Signal Management
Britta Kuhn / AGES – Austrian Agency for Health and Food Safety
Practical introduction to signal management, including signal detection, validation, assessment, prioritization, and regulatory processes for managing potential safety risks.

PV Interfaces
Mag. Marianne Kaniak / Amgen Austria GmbH
Overview of the cross-functional collaboration between Pharmacovigilance and key departments such as Regulatory Affairs, Quality, Medical Affairs, and Commercial.

PV Partnerships & Agreements
Mag. Regina Lauer / EVER Neuro Pharma GmbH
Introduction to different types of pharmacovigilance partnerships and agreements, including key elements, responsibilities, and best practices for PV Agreement management.

PV Inspections: Regulatory Authority Perspective & Industry Preparation
Dr. Elena Rodionova -  BASG/AGES
This session provides practical guidance on pharmacovigilance inspection readiness, including regulatory expectations, inspection processes, and effective management of inspection findings and CAPAs.
Key topics

• Oversight of pharmacovigilance inspections - regulatory requirements, focus areas
• The inspection lifecycle - preparation, conduct of the inspection, reporting, and follow‑up
• Best practices and tips for industry readiness
• How to effectively address inspection outcomes and CAPAs

Introduction to Artificial Intelligence in Pharmacovigilance
Dr. Sergiy Kryvych / Pfizer Germany
Insights into the use of Artificial Intelligence in pharmacovigilance, including practical examples and responsible AI implementation in daily PV activities at Pfizer.

Wrap-up & Questions
Lisbeth Andersen / Pfizer Corporation Austria
Summary of key takeaways, discussion, and open Q&A session.