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 0930-1000 Registration for delegates 1000 1015 Introduction to the tutorial (aims and objectives) 1015-1130 Case studies Shelley Gandhi, NDA 1130-1145 Coffee 1145-1230 Signal detection in spontaneous reports Introduction to signal detection in spontaneous reports Basic disproportionality measures (PRR, ROR) Measures with statistical shrinkage (IC, EBGM) 1230-1315 Lunch 1315-1415 Potential pitfalls of disproportionality analysis Confounding, masking, innocent bystanders, and case report duplication Outlook towards more sophisticated analytics: multivariate analysis and interaction detection 1415 1430 Discussion 1430-1445 Tea 1445-1630 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
8 TH BIENNIAL CONFERENCE ON 0845-0915 Registration for delegates 0915 0930 Introduction to the conference PROGRAMME Wednesday 10 June Chairperson morning: Andrew Bate Chairperson afternoon: Niklas Norén 0930-1015 Prospective surveillance of newly approved medical products using electronic healthcare databases Darren Toh Harvard Pilgrim Health Care Institute 1015-1100 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) 1100 1115 Coffee 1115-1145 The Convergence of Man and Machine 1145-1215 A regulator s perspective on signal detection Agnieszka Szmigiel European Medicines Agency (EMA) 1215-1230 Discussion 1230 1330 Lunch Chairperson afternoon: Niklas Norén 1330-1415 The use of free text in signal detection Andrew Bate Pfizer 1415-1445 A supervised learning approach for signal detection in large observational data sets Jenna Reps University of Nottingham 1445 1500 Tea
1500-1530 Missing data in longitudinal records Irene Petersen University College London 1530-1600 Matching key safety questions with appropriate quantitative signal detection algorithms for ensuring appropriate corrective action Lionel van Holle GlaxoSmithKline 1600-1645 Pharmacoepidemiologic studies using Nordic healthcare databases Morten Andersen Karolinska Institute 1645-1700 Discussion 1700 End of day one 1845 Complimentary networking dinner
8 TH BIENNIAL CONFERENCE ON PROGRAMME Thursday 11 June Chairperson: 0830-0900 Registration 0900 0905 Introduction to Day 2 0905 0950 Keynote presentation: The pharmacogenetic basis of adverse drug reactions Munir Pirmohamed University of Liverpool 0950 1020 Signal Detection for Biotech Products Lu Larham Amgen Limited 1020 1030 Discussion 1030 1045 Coffee 1045 1115 Signal detection in small companies Flic Gabbay TranScrip Partners 1115 1145 Meeting regulatory expectations in signal detection Shelley Gandhi NDA 1145 1230 Open Forum With active audience participation 1230 1330 Lunch 1330 1415 How to make signal detection more agile: reducing wasteful practices and facilitating innovation Niklas Norén Uppsala Monitoring Centre 1415-1445 Signal detection for mature products Ana-Claudia Ianos Pfizer 1445 1500 Tea
1500-1545 Emerging methods for signal detection: pharmacovigilance of digital media (A twit on Twitter!) David Lewis Novartis Pharma AG 1545-1615 Patient-generated data and digital engagement Edward Suggate Johnson & Johnson 1615-1630 Discussion and Summing up 1630 Close of meeting