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Maternal & Neonatal Health: Actions to Improve the Benefit Risk Assessment of Medicinal Products Used in Pregnancy
Session Chair(s)
David John Lewis, PhD
Former Head QPPV PRRC Office, Patient Safety & Pharmacovigilance
Novartis Pharma Gmbh, Switzerland
During our session we will provide the audience with an overview of the latest information and initiatives in understanding the safety and efficacy of medication use in pregnancy and lactation, through the product life-cycle. During our session, we offer the perspectives of key stakeholders including: the rapporteur for ICH E21, a healthcare professional specializing in maternal health, a regulator focusing on safety in pregnancy and breastfeeding.
Learning Objective : Discuss gaps and areas of improvement in the current safety ecosystem in pregnancy and breastfeeding, from five perspectives: -Patients -Healthcare professionals -Regulators -Academia -Pharmaceutical Industry
Speaker(s)
Framework for Inclusion of Pregnant Women into Clinical Trials, Focusing on the Concepts within ICH E21
Dorina Bischof, DrMed, MD
Novartis, Switzerland
SVP Global Head, Patient Safety and Pharmacovigilance
Recommendations on Maternal-Fetal Adverse Event Terminology (MFAET)
Rebecca Spencer, PhD
University of Leeds, United Kingdom
NIHR Clinical Lecturer and Subspecialty Trainee in Maternal and Fetal Medicine
Progressing the Regulatory Science Around Post-Authorisation Evaluation: The Use of Medicines in Pregnancy and Breastfeeding
Corinne de Vries, PhD, MA, MSc
European Medicines Agency, Netherlands
Head of Translational Sciences Office
Panelist
David John Lewis, PhD
Novartis Pharma Gmbh, Switzerland
Former Head QPPV PRRC Office, Patient Safety & Pharmacovigilance
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