Back to Agendas
Signalling: Dealing With the Traffic jam
Session Chair(s)
Shelley Gandhi, MSc
Strategic Advisor, Pharmacovigilance and Drug Safety
NDA Group, United Kingdom
Signal management is a key function in a pharmacovigilance quality management system. Thus a QPPV would be expected to show scientific direction and leadership around defining requirements and methodologies for worldwide sources of evidence. Concepts such as signal validation and causality assessment need to be addressed. New data sources such as big data and social media and technologies are being developed or have arrived. In particular, QPPVs need to think what will be the impact of examining EudraVigilance and other regulatory databases and what should this process look like for their Company. By combining traditional and new processes, QPPVs can keep their signalling processes relevant to maintain an adequate benefit-risk balance.
Speaker(s)
Signal Management in the EU: Key Principles and Process Optimisation
Georgy Genov, MD
European Medicines Agency, Netherlands
Head of PHV Office, ad-interim Head of Quality & Safety of Medicines Department
Signal Management – a QPPV’s Temperature Check
Sue Rees, MS
Sue Rees Consultancy Ltd, United Kingdom
Director
Signal Management: An SME Perspective
Winrich Rauschning, DrMed, MD, MBA
Biolitec Pharma, Germany
QPPV
Have an account?