Role of Real World Data for Regulatory Science when Randomized Clinical Trials are Not ‎Feasible: Lessons Learned from Perinatal Pharmacoepidemiology

Tuesday, August 27, 2024

10:00 AM – 11:30 AM CEST

Location: Conv Hall I A/B

Speaker(s)

Sandra Lopez Leon, MD PhD

Director Pharmacoepidemiologist
Novartis Pharma
East Hanover, United States

Slides
Sonia Hernandez-Diaz, MD, DrPH

Professor of Epidemiology
Harvard T.H. Chan School of Public Health
Boston, United States

Slides Handouts
Hedvig M.E Nordeng, PhD (she/her/hers)

Professor
Pharmacoepidemiology and Drug Safety Research Group, Department of Pharmacy, University of Oslo (UiO), Oslo, Norway
Oslo, Norway

Slides
Marleen M.H.J. van Gelder, PhD

Assistant Professor in Pharmacoepidemiology
Pharmacoepidemiology and Drug Safety research group, Department of Pharmacy, University of Oslo, Norway
Radboud university medical center
Nijmegen, Netherlands

Over the past 18 years, ISPE members contributed to generating knowledge improving the ‎quality of science and enhancing communication related to the use and safety of ‎medications in pregnancy and lactation (MiPaL). For ethical and medico-legal ‎considerations, this field heavily relies on observational studies, facing numerous ‎methodological challenges common to these designs. In this plenary session, we will ‎highlight advances in methodological approaches, the role of Real World Data to inform ‎regulation of pharmaceuticals and clinical recommendations, and future directions. The ‎session is inspired by accomplishments of MiPaL SIG members, but applicable to other ‎areas. ‎

Speakers
Sandra Lopez-Leon, MD, PhD; Director, Novartis, USA / Adjunct Faculty PETS, Rutgers ‎University, USA
Sonia Hernández-Díaz, MD, DrPH, FISPE; Professor, Harvard T.H. School of Public Health, ‎USA.‎
Hedvig Nordeng, PhD, MScPharm, FISPE; Professor, University of Oslo, Norway.‎
Marleen van Gelder, PhD; Assistant Professor, Radboud University Medical Center, The ‎Netherlands / University of Oslo, Norway.‎