This year Summit will host speakers from the world’s leading companies.
Corporate Vice President
Global Head International Pharmacovigilance
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.
Chief Safety Officer
Senior VP, Head Global Drug Safety and QPPV
VP & Head Regional Quality and Safety EMEA & APAC
SELECTED CASE STUDIES
Selected Case Studies from the Agenda
Magnus NORDVP Global Patient Safety CVMD
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
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
- Arabic League
- Literature Monitoring
- OC of in-coming cases
Jan CLEERBOUTDirector, Medical Safety Officer
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
Lydie MARCELONDeputy Director PV and RM
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.
- 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.