SPEAKERS

SAMPLE OF KEYNOTE SPEAKERS AND THEIR CASE STUDIES

Victoria BARTASEK

Senior Associate Director, Global Pharmacovigilance

CASE STUDY / DAY 1

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

CASE STUDY / DAY 1

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

Lisa STAGI

Drug Safety & Quality Head

SUMMIT WILL HOST SPEAKERS FROM THE WORLD’S LEADING COMPANIES

Andreas OSANGER

Director - Therapeutic Area Lead Nephrology

CASE STUDY DAY 2

Building PV Partnerships for Drug Product Portfolios

Monika MANSKE

Lead Quality Management and Deputy EEA QPPV

CASE STUDY DAY 2

PV Audit and Inspection Challenges During Pandemic Situation

• Pharmacovigilance System Master File (PSMF)
• Inspection readiness
• Internal PV audits
• Audits by license partner
• How to handle audits in remote situations (COVID-19)
• How will audits be continued after the pandemic?

Stephanie TCHERNY

Global Head of Benefit-Risk Evaluation

CASE STUDY DAY 2

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

Victoria BARTASEK

Senior Associate Director, Global Pharmacovigilance

CASE STUDY DAY 1

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

Lisa STAGI

Drug Safety & Quality Head

CASE STUDY DAY 1

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

Stephanie TCHERNY

Global Head of Benefit-Risk Evaluation

CASE STUDY / DAY 2

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
CASE STUDY / DAY 2

Building PV Partnerships for Drug Product Portfolios

Andreas OSANGER

Director - Therapeutic Area Lead Nephrology

Monika MANSKE

Lead Quality Management and Deputy EEA QPPV

CASE STUDY / DAY 2

PV Audit and Inspection Challenges During Pandemic Situation

  • Pharmacovigilance System Master File (PSMF)
  • Inspection readiness
  • Internal PV audits
  • Audits by license partner
  • How to handle audits in remote situations (COVID-19)
  • How will audits be continued after the pandemic?

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

Event programme

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Inside you will find

  • What keynote speakers will be taking part in the exclusive speaking panel
  • What Case Studies will be discussed by our senior corporate speakers
  • The minute by minute breakdown of the conference