9th Annual Risk Management and Pharmacovigilance Summit

26 - 27 October 2022 | Austria Trend Hotel Ananas

PAST SPEAKERS

SEE THE PREVIOUS SPEAKERS & CASE STUDIES

Andreas OSANGER

Director - Therapeutic Area Lead Nephrology

Monika MANSKE

Lead Quality Management and Deputy EEA QPPV

Stephanie TCHERNY

Global Head of Benefit-Risk Evaluation

Victoria BARTASEK

Senior Associate Director, Global Pharmacovigilance

Lisa STAGI

Drug Safety & Quality Head

CONFERENCE TOPICS 2022

LOOK AT THE TOPICS THAT WERE DISCUSSED

  • Safety reporting activities due to the COVID-19 pandemic: What are the pillars?
  • Challenges measuring the effectiveness of risk minimisation measures
  • How to design a patient centred pharmacovigilance system?
  • Augmenting decision-making in PV through artificial intelligence
  • What are the safety standards for pharmaceutical products?
  • Automation in pharmacovigilance data processing: Do you trust artificial intelligence?
  • How did the pandemic push pharmacovigilance to innovate?
  • The impact of new technologies on PV system

Designed for

Members of board, C-level, Senior/Global Vice Presidents, Directors, Heads of departments from the pharma industry involved in:

  • 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

How to Effectively Manage the Adverse Event Data from Digital Initiatives?

Victoria BARTASEK

Senior Associate Director, Global Pharmacovigilance

Lisa STAGI

Drug Safety & Quality Head

CASE STUDY

Patient Associations and Patients as Key Players in Pharmacovigilance: Reflections

The importance of proper awareness of patients and more involvement in PV activities is a key topic in the evolution on PV world. I propose to present the experience gained in this area through the work done also with the support of Patient associations.

  • PV awareness from Patients
  • Opportunities for more involvement of patients and a patient
    centric approach to PV activities
CASE STUDY

Advances in Structured Benefit-Risk Assessment

This presentation aims to display the recent advances in Benefit-Risk field from new regulatory guidance, changes in BR methods to illustration of growing role of patient experience data into BR evaluation.

  • Recent changes in Benefit-Risk regulatory landscape
  • Improved use of Patient Experience Data for Benefit-Risk evaluation
  • Trends and perspectives for the future in Benefit-Risk methods

Stephanie TCHERNY

Global Head of Benefit-Risk Evaluation

Andreas OSANGER

Director - Therapeutic Area Lead Nephrology

CASE STUDY

Building PV Partnerships for Drug Product Portfolios

CASE STUDY

From Call Center to Customer Engagement Center

We will guide you through our experience in the changing the concept of the Contact Center and implementation of the new strategy with the help of the technology.

• Creating the strategy
• New purpose and value drivers
• People and Technology
• Remote sales

Monika MANSKE

Lead Quality Management and Deputy EEA QPPV

I really enjoyed learning from highly relevant presentations and lively discussions, and I will be definitely very happy to join the summit next year.

– Associate Director Global Regulatory Affairs, Translational Medicine & Devices, Merck

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