Skip to main content
2024 ISPE Annual Meeting Main banner
Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.
Back
Evaluation Video

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, MD MBChB (he/him/his) – LCP

    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