Members of board, C-level, Senior/Global Vice Presidents, Directors, Heads of departments from pharmaceutical industry involved in:
10th Annual Risk Management and Pharmacovigilance Summit
10 – 11 May 2023 | InterContinental Vienna
PAST SPEAKERS
SEE THE PREVIOUS SPEAKERS & CASE STUDIES
Andrea Oliva
Head of Pharmacovigilance, Italy
Petros Mavrogenis
Head Vigilance Process Excellence
Khaudeja Bano
VP Combination Product Quality
Birna Kristín Eiríksdóttir
Associate Director, Senior Pharmacovigilance Scientist
Majken Berghuis
Pharmacovigilance Director
CONFERENCE TOPICS 2023
LOOK AT THE TOPICS THAT WERE DISCUSSED
- What is the role of digital media and Artificial Intelligence (AI)? How do we go digital?
- How can companies achieve better results and practical usage of digital tools in their PV process?
- Difference of Good Pharmacovigilance Practices (GVP) interpretation between generic traditional and innovation modules in the pharma sector
- How to build effective metrics for vendor oversight. Partnership performance on outgoing bases
- Patient safety & risk management for pharmacovigilance and drug safety
- What are the new essential pharmacovigilance requirements in the EU and UK regulations?
Designed for
- Pharmacovigilance
- Risk Management
- PV Monitoring
- Signal Detection
- Data Collection
- Patient Safety
- Drug Safety
- Benefit-Risk Evaluation
- Quality Assurance
- Reporting and Data Collection
- Compliance
- Inspections
- Management Safety Data
- Lifecycle Management Quality
- Clinical Safety
CASE STUDY
Pharmacovigilance and Social Media
Social media is part of everyday life, and pharmaceutical companies are also moving more and more in this direction. Like all corporate business projects, social media must also meet the requirements to comply with pharmacovigilance obligations. We will see how they can be managed from a pharmacovigilance point of view.
- PV responsibilities on social media
- How to classify social media from a PV perspective
- Workflow examples of social media screening
Andrea Oliva
Head of Pharmacovigilance, Italy
Viatris
Petros Mavrogenis
Head Vigilance Process Excellence
Novartis
CASE STUDY
Does Repeated Follow-up Produce Better Quality Safety Data? Effort vs Reward
An analysis of follow-up attempts for adverse event reports was conducted to describe the characteristics of a risk-based follow-up for Individual Case Safety Reports (ICSR)
CASE STUDY
Demystify Impact of Combination products on PV and Risk Management
While our product portfolios continue to add combination products in the mix, leading to increasing complexity throughout the PV process there needs to be a deeper understanding of the device aspect including malfunctions and unique safety related requirements. The risk management process mow needs to incorporate the device related risk and more.
- Discuss the evolving landscape of Combination product globally
- Key challenges and areas of focus
- Industry best practices to better integrate combination products in PV
Khaudeja Bano
VP Combination Product Quality
Amgen
Birna Kristín Eiríksdóttir
Associate Director, Senior Pharmacovigilance Scientist
AstraZeneca
CASE STUDY
Applying Who-UMC Causality Criteria to Vaccines: A COVID-19 Vaccine Experience
During the pandemic, there was a requirement to apply WHO-UMC causality criteria on a case level for safety evaluations. This criterion has limitations when used for vaccines due to the lack of possibility of rechallenge/dechallenge and withdrawal for vaccines, leaving some room for individual interpretation when applying the criteria. To overcome this challenge, a supporting algorithm was developed to ensure consistent causality assessment when volumes are high, and many people are reviewing cases.
- WHO-UMC causality criteria have limitations when applied to vaccines
- Rechallenge/dechallenge or withdrawal is not possible
- Leaves room for individual interpretation of how to apply the criteria
- To overcome challenges, a supporting algorithm was developed to ensure consistency
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