Publications by authors named "Amalia Alexe"

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Delphi Method Consensus on Statistical Analysis and Reporting Recommendations for Single-Arm Pregnancy Medication Safety Studies Investigating Pregnancy, Birth and Neonatal Health Outcomes: A Contribution from IMI-ConcePTION.
Jonathan L Richardson, Alan Moore, Michael Stellfeld, Yvonne Geissbühler, Ursula Winterfeld, Amalia Alexe

Drug Saf· June 2025

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Points to Consider on the Use of Medicines in Pregnancy Throughout the Product Lifecycle Based on Global Regulatory Guidance.
Amalia Alexe, Keele Wurst, Leesha Balramsingh-Harry, Olatayo Apara, Nadezda Abramova

Ther Innov Regul Sci· May 2025

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Post-approval Activities Providing Data on the Safety of Medication Use During Pregnancy and Lactation-A TransCelerate Perspective.
Maria Fernanda Scantamburlo Fernandes, Amalia Alexe, Olatayo Apara, Lindsey Force, Christine Taeter

Ther Innov Regul Sci· May 2025

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Call to action: Harmonization of pharmacovigilance regulations for post-marketing pregnancy and breastfeeding safety studies.
Amalia Alexe, Osa Eisele, Maria Fernanda Scantamburlo Fernandes, Anju Garg, Birgit Kovacs

Br J Clin Pharmacol· March 2024

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Regulations Governing Medicines for Maternal and Neonatal Health: A Landscape Assessment.
Amalia Alexe, Anju Garg, Birgit Kovacs, Nadezda Abramova, Olatayo Apara

Ther Innov Regul Sci· March 2024

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Core Data Elements for Pregnancy Pharmacovigilance Studies Using Primary Source Data Collection Methods: Recommendations from the IMI ConcePTION Project.
Jonathan L Richardson, Alan Moore, Rebecca L Bromley, Michael Stellfeld, Yvonne Geissbühler, Amalia Alexe

Drug Saf· May 2023

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The evolution of pharmacovigilance ecosystems: Does Moore's law invite the use of Occam's razor?
Marion Mueller, David J Lewis, Amalia Alexe

Br J Clin Pharmacol· February 2023

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