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  • Sunday, Aug 24th
    5:15 PM - 6:45 PM ET
    SW-2D - The Future of Pharmacovigilance: Accelerating Signal Identification With Electronic Healthcare Data
    Location: 202AB
    Presenting Author: Jian-Yu E, ScD, MPH, MD – Sanofi
    Co-Author: Judith C. Maro – Harvard Medical School & Harvard Pilgrim Health Care Institute
    Co-Author: Patrick Ryan, PhD – Johnson & Johnson
    Co-Author: Monica Muñoz, PhD – U.S. Food and Drug Administratio
    Co-Author: Catherine C. Cohet, PhD – European Medicines Agency
    Co-Author: G. Caleb Alexander, MD, MS – Johns Hopkins University, Department of Epidemiology
    Co-Author: Benjamin D. Bray, MD MBChB (he/him/his) – Lane Clark & Peacock LLP
    Co-Author: Juhaeri Juhaeri, PhD – Sanofi
    Pharmacovigilance / Other
  • Monday, Aug 25th
    4:15 PM - 4:30 PM ET
    4E-01 - Severe infections risk assessment score for patients with rheumatoid arthritis receiving targeted therapies: development and validation in a Nationwide cohort
    Presenting Author: Mounya Abboud – EpiDermE ( Epidemiology in Dermatology and Evaluation of therapeutics)- Université Paris-Est Créteil (UPEC)
    Co-Author: Emilie Sbidian, PhD, MD – EpiDermE ( Epidemiology in Dermatology and Evaluation of therapeutics)- Université Paris-Est Créteil (UPEC)
    Co-Author: Mahmoud Zureik, PhD, MD – EPI-PHARE Scientific Interest Group in Epidemiology of Health Products from the French National Agency for the Safety of Medicines and Health Products and the French National Health Insurance, St Denis, France ; Paris Saclay University, Université Versailles Saint Quentin (UVSQ - EDSP)
    Pharmacovigilance / Other
  • Monday, Aug 25th
    5:00 PM - 5:15 PM ET
    4E-04 - Bigger is better: replicating a signal detection study using tree-based scan statistics in two real world data sources
    Presenting Author: Ashley V. Howell, MPH, PhD – Regeneron Pharmaceuticals, Inc
    Co-Author: Alexander Breskin – Regeneron Pharmaceuticals, Inc.
    Co-Author: Julius Asubonteng – Regeneron Pharmaceuticals, Inc.
    Co-Author: Ping Shao, MS – Regeneron Pharmaceuticals, Inc.
    Co-Author: Shiyao Gao – Regeneron Pharmaceuticals Inc.
    Co-Author: Ihtisham Sultan, PhD, PharmD – Regeneron Pharmaceuticals, Inc
    Co-Author: Rachel E. Sobel – Regeneron Pharmaceuticals, Inc.
    Co-Author: Andrea Marcus – Regeneron
    Pharmacovigilance / Other
  • Tuesday, Aug 26th
    8:45 AM - 9:00 AM ET
    5D-02 - Assessing a Signal of Congenital Anomalies Following Dydrogesterone Exposure in Pregnancy: Results From a Disproportionality Analysis (DPA) and Systematic Review
    Co-Author: Amy Bobbins, MPharm, Msc – Drug Safety Research Unit
    Co-Author: Taylor Aurelius – Drug Safety Research Unit (DSRU), Southampton, UK
    Co-Author: Alison Yeomans – Drug Safety Research Unit (DSRU), Southampton, UK
    Presenting Author: Sandeep Dhanda – Drug Safety Research Unit (DSRU), Southampton, UK
    Co-Author: Debabrata Roy – Drug Safety Research Unit (DSRU), Southampton, UK
    Co-Author: Miranda Davies – Drug Safety Research Unit (DSRU), Southampton, UK
    Pharmacovigilance / Other
  • Tuesday, Aug 26th
    9:00 AM - 9:15 AM ET
    5D-03 - Charting the Pitfalls of Disproportionality Analysis
    Presenting Author: Michele Fusaroli – Uppsala Monitoring Centre
    Co-Author: Daniele Sartori – Uppsala Monitoring Centre
    Co-Author: Judith Brand – Uppsala Monitoring Centre
    Co-Author: G Niklas Norén – Uppsala Monitoring Centre
    Pharmacovigilance / Other
  • Tuesday, Aug 26th
    9:15 AM - 9:30 AM ET
    5D-04 - Amalgamation of Real World Data, bioinformatics analysis and computational biology techniques for unveiling the mechanism of the signal detected for Rucaparib via Disproportionality Analysis
    Presenting Author: Anshaj Sharma – Department of Pharmacy Practice, Faculty of Pharmacy, M.S. Ramaiah University of Applied Sciences
    Co-Author: Pramod Kumar Adusumilli, MPharm, PhD – Department of Pharmacy Practice, Faculty of Pharmacy, M.S. Ramaiah University of Applied Sciences
    Co-Author: G.R. Saraswathy, PhD – Department of Pharmacy Practice, Faculty of Pharmacy, M.S. Ramaiah University of Applied Sciences
    Co-Author: Gouri Nair, PhD – Department of Pharmacology, Faculty of Pharmacy, M S Ramaiah University of Applied Sciences, Bengaluru, Karnataka, India
    Pharmacovigilance / Other
  • Tuesday, Aug 26th
    9:45 AM - 10:00 AM ET
    5D-06 - Automated Causality Assessments of Individual Case Safety Reports
    Presenting Author: Greg Powell – GSK
    Co-Author: Olivia Mahaux – GSK
    Co-Author: Vijay Kara – GSK
    Co-Author: Francois Haguinet – GSK
    Co-Author: Debra Rogan – GSK
    Co-Author: Andrew Bate – GSK
    Pharmacovigilance / Other