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Evaluation

Lightning Session 3

Wednesday, August 28, 2024
8:30 AM – 10:00 AM CEST
Location:Room III

Presentations:

  • 8:30 AM – 8:35 AM CEST
    Periconceptional Oral Contraceptive Use and the Risk of Spontaneous Abortion: Results From the PRIDE Study.

    Co-Author: Michael Ceulemans, PharmD, PhD – Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium

    Co-Author: Lieve Tuitjer – IQ Health, Radboud university medical center, the Netherlands

    Co-Author: Nel Roeleveld – IQ Health, Radboud university medical center, the Netherlands

    Co-Author: Marc Spaanderman – Department of Obstetrics & Gynecology, Radboud university medical center, the Netherlands

    Presenting Author: Marleen M.H.J. van Gelder, PhD – Pharmacoepidemiology and Drug Safety research group, Department of Pharmacy, University of Oslo, Norway

  • 8:35 AM – 8:40 AM CEST
    Impacts of Dobbs Decision and COVID-19 on Abortion-related Trends within TriNetX Electronic Medical Record Data

    Presenting Author: Sara A. Ephross – Syneos Health

    Co-Author: Nicole Carneal-Frazer, PhD – Syneos Health

    Co-Author: Jacquelyne Brauneis – Syneos Health

    Co-Author: Jessica D. Albano – Syneos Health

  • 8:40 AM – 8:45 AM CEST
    Trends in Mifepristone Dispensing in the United States: 2016–2023

    Presenting Author: Laura E. Dodge, ScD, MPH (she/her/hers) – Optum Epidemiology

    Co-Author: Hannah Katcoff – Optum Epidemiology

    Co-Author: Laura Yochum – Optum Epidemiology

    Co-Author: Andrea Chomistek, MPH, ScD – Optum Epidemiology

  • 8:45 AM – 8:50 AM CEST
    Evolution of Contraceptive Use in France From 2012 To 2022

    Presenting Author: Lorraine PONCET, PhD – EPI-PHARE, French National Agency for Medicines and Health Products Safety (ANSM) and French National Health Insurance (CNAM)

    Co-Author: Noémie Roland, PhD – EPI-PHARE

    Co-Author: Romain Fortuna – EPI-PHARE, French National Agency for Medicines and Health Products Safety (ANSM) and French National Health Insurance (CNAM)

    Co-Author: Rosemary Dray-Spira – EPI-PHARE, French National Agency for Medicines and Health Products Safety (ANSM) and French National Health Insurance (CNAM), 143-147 Boulevard Anatole France, 93285, Saint-Denis, France

    Co-Author: Alain Weill, MD – EPI-PHARE, French National Agency for Medicines and Health Products Safety (ANSM) and French National Health Insurance (CNAM), 143-147 Boulevard Anatole France, 93285, Saint-Denis, France

    Co-Author: Mahmoud Zureik, Phamacoepidemiology professor – EPI-PHARE, French National Agency for Medicines and Health Products Safety (ANSM) and French National Health Insurance (CNAM), 143-147 Boulevard Anatole France, 93285, Saint-Denis, France

  • 9:00 AM – 9:05 AM CEST
    Identifying Novel Endpoints in Rare Disease Studies Using Real-World Evidence: A Regulatory Science Perspective

    Presenting Author: Julien E. Heidt, MS – IQVIA

    Co-Author: Reid D'Amico, PhD – IQVIA

    Co-Author: Christina D. Mack, PhD, FISPE – IQVIA

  • 9:05 AM – 9:10 AM CEST
    Feasibility of Prospective Real-World Studies to Fulfill Regulatory Commitments and Requirements in Oncology within the United States (US)

    Presenting Author: Eric S. Meadows, PhD – Flatiron Health

    Co-Author: Matthew W. Reynolds, PhD, FISPE – Azimuth Research Group

    Co-Author: Angela Chen, PharmD – Flatiron Health

    Co-Author: Jenna M. Collins, MPH – Flatiron Health

    Co-Author: Majd T. Ghanim, MD, MSCR – Flatiron Health

    Co-Author: Ivy Altomare, MD – Flatiron Health

    Co-Author: Craig A. Serra, MS, MBA – Flatiron Health

    Co-Author: Nicole Liaw, PharmD, MBA – Flatiron Health

  • 9:10 AM – 9:15 AM CEST
    Time Intervals between Milestones of Studies Evaluating the Effectiveness of Risk Minimisation Measures Assessed by PRAC

    Presenting Author: Sharon C.M Essink, MSc (she/her/hers) – Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.

    Co-Author: Inge M. Zomerdijk – Department of Pharmacovigilance, Medicines Evaluation Board, Utrecht, The Netherlands.

    Co-Author: Thomas Goedecke – European Medicines Agency, Amsterdam, The Netherlands.

    Co-Author: Sabine M.J.M. Straus – Department of Pharmacovigilance, Medicines Evaluation Board, Utrecht, The Netherlands.

    Co-Author: Helga Gardarsdottir, PharmD, PhD, FISPE (she/her/hers) – Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, The Netherlands

    Co-Author: Marie L. De Bruin – Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.

  • 9:15 AM – 9:20 AM CEST
    Revolutionising Regulatory Science with Natural Language Processing: a case study on Paediatric Investigation Plans

    Co-Author: Saeed Shakibfar – University of Copenhagen

    Presenting Author: Christine E. Hallgreen, PhD – University of Copenhagen

    Co-Author: Maurizio Sessa, PharmD – Department of Drug Design and Pharmacology, University of Copenhagen

  • 9:30 AM – 9:35 AM CEST
    Validity of pharmaceutical claims data for determining medication exposure in long-term care facilities

    Co-Author: Emma K. Pearce, BPharm(Hons), BPharmSci – University of South Australia, UniSA Clinical & Health Sciences, Adelaide, South Australia, Australia

    Co-Author: Geraint Rogers, PhD – South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia

    Co-Author: Lucy Carpenter, PhD – South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia

    Co-Author: Maria C. Inacio, MS, PhD – Registry of Senior Australians (ROSA), South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia

    Co-Author: Gillian E. Caughey, PhD – Registry of Senior Australians (ROSA), South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia

    Co-Author: Andrew Shoubridge, PhD – South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia

    Co-Author: Lito Papanicolas – South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia

    Presenting Author: Janet K. Sluggett, PhD, BPharm(Hons), GDip ClinEpid, FANZCAP, FSHP (she/her/hers) – University of South Australia

  • 9:35 AM – 9:40 AM CEST
    Assessment of laboratory data quality in real-world data

    Presenting Author: Xinyue Liu, PhD – Epidemiology, Merck & Co., Inc.

    Co-Author: Tianchen Lyu – Health Outcomes & Biomedical informatics, University of Florida

    Co-Author: Xing He – Health Outcomes & Biomedical informatics, University of Florida

    Co-Author: Lihai Song – Biostatistics and Research Decision Sciences, Merck & Co., Inc.

    Co-Author: Edward Bortnichak – Epidemiology, Merck & Co. Inc.

    Co-Author: Jiang Bian, PhD – College of Medicine, University of Florida

  • 9:40 AM – 9:45 AM CEST
    From Theory to Practice: The Impact of the NICE Real-World Evidence Framework in Health Technology Assessment

    Co-Author: Natalie Tikhonovsky – Lane Clark & Peacock LLP

    Co-Author: Nishit Dhanji – Lane Clark & Peacock LLP

    Presenting Author: Benjamin D. Bray – Lane Clark and Peacock LLP

    Co-Author: Sreeram Ramagopalan – Lane Clark & Peacock LLP

  • 9:45 AM – 9:50 AM CEST
    Framework for the application of Pharmacoepidemiology and Real-World Data analysis in Safety Signal Assessments

    Presenting Author: Suzanne N. Landi, MPH, PhD – GlaxoSmithKline

    Co-Author: O'Mareen Spence, PhD – GSK

    Co-Author: Heather Ecklund, MPH – GSK

    Co-Author: Cailey Smith, ScM – GSK

    Co-Author: Kieran J. Rothnie, PhD – GSK

    Co-Author: Rachel Cohen, MPH – GSK

    Co-Author: Diana Martins, MSc – GSK

    Co-Author: Keele Wurst, PhD – GSK