SAMPLE OF KEYNOTE SPEAKERS

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

Magnus
NORD

VP Global Patient Safety CVMD

Karsten
LOLLIKE

Corporate Vice President

Jan
CLEERBOUT

Director, Medical Safety Officer

Kristof
VANFRAECHEM

Global Head International Pharmacovigilance

Lydie
MARCELON

Deputy Director Pharmacoepidemiology and Risk Management

Pilar
CARRERO

Vice President, QPPV Office

PAST SPEAKERS INCLUDE

Last year was our summit successful  because we host speakers from world’s leading companies. See sample of them.

Mircea
CIUCA

Head Medical & Clinical Drug Safety

Susan
WELSH

Chief Safety Officer

Stephanie
COLLOMB-GILBERT

EU QPPV and Deputy Director, PVRM Group (Young Products)

Peter
DE VEENE

Senior VP, Head Global Drug Safety and QPPV

Jane
FERON

Pharmacovigilance Process Lead

Salvatore
CURTI

VP & Head Regional Quality and Safety EMEA & APAC

SELECTED CASE STUDIES

Selected Case Studies from the Agenda

Magnus NORDVP Global Patient Safety CVMD
AstraZeneca

Delivering Strategic Clinical Drug Safety and PhV – Learnings from AstraZeneca

The last few years AstraZeneca-MedImmune has developed the clinical drug safety and pharmacovigilance organisation to shift focus from routine license-to-operate and pharmacovigilance activities, to strategic support for decision-making for drug projects and products. This has included advancing predictive and reactive scientific approaches in drug safety, launching a new operating model and organisational structure and reducing the procedural framework over 60%, key learnings and case studies from this journey will be presented.

  • Refocus from Routine License-to-operate activities to Strategic support for decision-making
  • Novel Predictive Statistical methods and Mechanistic PK-PD modeling for safety
  • Using Large Data Networks for Clinical Drug Safety and PhV-Risk Management
  • Reducing the Procedural framework in a major global pharmaceutical company
  • Off-shoring vs Outsourcing of routine safety tasks
Karsten LOLLIKECorporate Vice President
NovoNordisk

Learnings from PV Inspections (Europe and Arabic League)

Feedback from PV inspections are part of shaping the PV systems. The presenter will discuss findings from EMA PV Inspection, especially focus on IT-systems. The presenter will also highlight major findings from global PV inspections especially in Arabic countries where new PV legislation is enforced.

  • PV Inspections
  • EMA
  • Arabic League
  • IT-Systems
  • Literature Monitoring
  • OC of in-coming cases
Jan CLEERBOUTDirector, Medical Safety Officer
Johnson&Johnson

Signal detection and management: a pharmaceutical industry perspective
and future approaches

  • Different tools to support signal detection and safety monitoring
  • Reaction monitoring reports, emerging safety issues
  • Implementation of the pharmacovigilance legislation
  • Scope and objectives of GVP module
  • Involvement in signal detection and management
  • New approaches to signal management
Mélanie ESSEVAZ-ROULETLead of Country Quality Oversight
Sanofi
Lydie MARCELONDeputy Director PV and RM
Sanofi Pasteur

New Vaccine launch – how to improve PV awareness and reporting in low middle income countries

The introduction of a new Dengue vaccine was targeting the first launched in low and middle income countries through mass vaccination campaigns. The LMIC countries have heterogeneous PV systems and some require capacity building.
In this context, the ultimate objective is to avoid to jeopardize the mass vaccination campaign after launch due to a lack of information regarding the safety of the vaccine / minimize the risk of media crisis and false signal. Stimulation of AEs reporting by patients/HCP is critical to further characterize the safety profile of our new vaccine in real life setting.

How:

  • Implement an easy-to-use web and interactive solution to collect the PV data from HCP through PC, tablets and smartphones.
  • b-Set-up a prospective multi-national non-interventional post-authorization safety study consisted of a Cohort Event Monitoring using standardized data collection instruments through patient cards to be distributed to 30 000 vaccines & electronic Case Report Form to be filled in by HCPs.