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This guideline aims at providing criteria to select medicinal products for which active surveillance for collecting post-authorisation data in pregnancy is necessary. It provides guidance on how to monitor accidental or intended exposure to medicinal products during pregnancy and specific requirements for
This document describes how to assess the risk of an adverse reproductive/developmental effect in human based on reproductive toxicity studies in animals and human clinical data. It addresses information to be included in the summary of product characteristics on how to use the medicinal product taking into account the nature of the risk.
The European Medicines Agency's (EMA) provides answers to frequently asked questions on good manufacturing practice (GMP) and good distribution practice (GDP), as discussed and agreed by the GMP/GDP Inspectors Working Group.
EMA’s Guideline on good pharmacovigilance practices (GVP) - Product- or Population-Specific Considerations III: Pregnant and breastfeeding women lists key periods of embryo-foetal susceptibility and a pregnancy classification based on duration that can be used for protocol development.
8 paź 2003 · Part IV - GMP requirements for Advanced Therapy Medicinal Products. Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products; Other documents related to GMP and GDP. Compilation of Union Procedures on Inspections and Exchange of Information
Objectives. The main objective for the EUROCAT Joint Action, WP9, is to develop the conditions for a European monitoring system for safety of medication use in pregnancy, whereby signal detection and implementation can be performed, mainly using case-malformed control study designs.
Codes from this chapter are for use for conditions related to or aggravated by the pregnancy, childbirth, or by the puerperium (maternal causes or obstetric causes) Trimesters are counted from the first day of the last menstrual period. They are defined as follows: 1st trimester- less than 14 weeks 0 days.
