Search results
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
The exposure to medicinal products during pregnancy: need for post-authorisation data; ICH S3A Toxicokinetics: the assessment of systemic exposure in toxicity studies; ICH S5 (R2) Reproductive toxicology: detection of toxicity to reproduction for medicinal products including toxicity to male fertility
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.
Another algorithm prospectively identifies codes for gestational age using the US-specific ICD-10-CM coding system in US health claims (Identification of pregnancies and infants within a US commercial healthcare administrative claims database, Pharmacoepidemiol Drug Saf. 2022 May 27).
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
30 wrz 2021 · Abstract. Introduction. Pregnancy outcome identification and precise estimates of gestational age (GA) are critical in drug safety studies of pregnant women.
For routine prenatal outpatient visits for patients with high-risk pregnancies, a code from category O09, Supervision of high-risk pregnancy, should be used as the first-listed diagnosis. Secondary chapter 15 codes may be used in conjunction with these codes if appropriate.
