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SPEAKERS

SAMPLE OF KEYNOTE SPEAKERS AND THEIR CASE STUDIES

Sally
LEE

Senior Director, Epidemiology, Global Drug Safety and Risk Management

CASE STUDY / DAY 1

Use of Real World Data in Supporting Pharmacovigilance

Real world data/evidence has become a hot topic in the pharmaceutical industry in the past decade. This presentation will focus on how RWD/RWE can be applied within pharmacovigilance field in order to assess safety profile of treatment in the real world setting.

  • Potential sources of RWD for pharmacovigilance
  • Types of studies using RWD to support PV
  • Examples of studies using RWD in PV
  • Future of RWD in PV

CASE STUDY / DAY 1

One Step Ahead: From Medical Monitoring to Signal Detection in Clinical Development

Medical monitoring is the industry standard when conducting Phase 1-3 clinical trials. However, are we sure that we do not miss any safety signals? Analysing drug safety data – possibly in real time – in an aggregated manner may support signal detection activities in our clinical development programs. And can we learn from the well-established post-marketing signal detection management?

  • Signal detection and management in clinical studies
  • Pre-marketing safety surveillance
  • Advanced medical monitoring
  • Clinical drug safety

Andreas
Osanger

Head of Clinical Drug Safety

This year Summit will host speakers from the world’s leading companies.
See sample of key note speakers.

Magnus
NORD

Vice President Global Patient Safety CVRM

Sally
LEE

Senior Director, Epidemiology, Global Drug Safety and Risk Management

Richard
HUGHES

Safety Science Senior Medical Director

Matthias
BÖDDING

Senior Director, Global Drug Safety Medicine

Andreas
OSANGER

Head of Clinical Drug Safety

Tina
VEIZOVIC

Senior Director, Growth & Emerging Markets, PV Affiliate Relations

CASE STUDY / DAY 2

Communicating Safety to Patients and Clinicians

The role of pharma in communicating safety information has traditionally revolved solely around regulatory requirements. This talk will explore the demand from patients and clinicians for a broader and more transparent communication of safety data from not only clinical trials, but also the post-marketing setting.

  • The history of safety
  • Safety in the digital world
  • Two views of safety information communication
  • Case study – Ocrevus in Multiple Sclerosis

Richard
HUGHES

Safety Science Senior Medical Director

Tina
VEIZOVIC

Senior Director, Growth & Emerging Markets, PV Affiliate Relations

CASE STUDY / DAY 2

Pharmacovigilance in the Emerging Markets

The presentation will cover emerging markets regulations and industry response, PV model of Takeda and strategies such as Access to Medicine.

  • Pharma in Emerging Markets
  • PV in the Emerging Markets
  • Regulatory Landscape
  • Harmonization efforts
FOR MORE INFORMATION REQUEST FULL PROGRAMME

See what keynote speakers will be taking part in the exclusive speaking panel.
Explore what Case Studies will be discussed by our senior corporate speakers

6th Annual Risk Management and Pharmacovigilance Summit
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