Drug Safety Research Unit. 8 th BIENNIAL CONFERENCE ON SIGNAL DETECTION AND INTERPRETATION IN PHARMACOVIGILANCE
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1 8 th BIENNIAL CONFERENCE ON PROGRAMME Tuesday 9 June 2015 (Pre-conference tutorial) Tutors: Patrick Ryan, Janssen Research and Development and Observational Health Data Sciences and Informatics (OHDSI) Shelley Gandhi, NDA Registration for delegates Introduction to the tutorial (aims and objectives) Case studies Shelley Gandhi, NDA Coffee Signal detection in spontaneous reports Introduction to signal detection in spontaneous reports Basic disproportionality measures (PRR, ROR) Measures with statistical shrinkage (IC, EBGM) Lunch Potential pitfalls of disproportionality analysis Confounding, masking, innocent bystanders, and case report duplication Outlook towards more sophisticated analytics: multivariate analysis and interaction detection Discussion Tea Analysis of longitudinal databases Patrick Ryan, Janssen Research and Development, and Observational Health Data Sciences and Informatics (OHDSI) Available clinical databases worldwide Epidemiology designs Strategies for dealing with bias 1630 End of pre-conference tutorial
2 8 TH BIENNIAL CONFERENCE ON Registration for delegates Introduction to the conference PROGRAMME Wednesday 10 June Chairperson morning: Andrew Bate Chairperson afternoon: Niklas Norén Prospective surveillance of newly approved medical products using electronic healthcare databases Darren Toh Harvard Pilgrim Health Care Institute Applying Hill's criteria as a framework for causal inference in observational data Patrick Ryan Janssen Research and Development, and Observational Health Data Sciences and Informatics (OHDSI) Coffee The Convergence of Man and Machine A regulator s perspective on signal detection Agnieszka Szmigiel European Medicines Agency (EMA) Discussion Lunch Chairperson afternoon: Niklas Norén The use of free text in signal detection Andrew Bate Pfizer A supervised learning approach for signal detection in large observational data sets Jenna Reps University of Nottingham Tea
3 Missing data in longitudinal records Irene Petersen University College London Matching key safety questions with appropriate quantitative signal detection algorithms for ensuring appropriate corrective action Lionel van Holle GlaxoSmithKline Pharmacoepidemiologic studies using Nordic healthcare databases Morten Andersen Karolinska Institute Discussion 1700 End of day one 1845 Complimentary networking dinner
4 8 TH BIENNIAL CONFERENCE ON PROGRAMME Thursday 11 June Chairperson: Registration Introduction to Day Keynote presentation: The pharmacogenetic basis of adverse drug reactions Munir Pirmohamed University of Liverpool Signal Detection for Biotech Products Lu Larham Amgen Limited Discussion Coffee Signal detection in small companies Flic Gabbay TranScrip Partners Meeting regulatory expectations in signal detection Shelley Gandhi NDA Open Forum With active audience participation Lunch How to make signal detection more agile: reducing wasteful practices and facilitating innovation Niklas Norén Uppsala Monitoring Centre Signal detection for mature products Ana-Claudia Ianos Pfizer Tea
5 Emerging methods for signal detection: pharmacovigilance of digital media (A twit on Twitter!) David Lewis Novartis Pharma AG Patient-generated data and digital engagement Edward Suggate Johnson & Johnson Discussion and Summing up 1630 Close of meeting
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