Risk management and monitoring methods for the future mother, embryo, fetus, and post-natal consequences.
Data required to asses the risk of a new drug regarding the normal course of pregnancy as well as embryo, fetal and neonate development, are often missing when a new product is launched. In such a situation, a risk management plan is to be developed by the industrial and validated by regulatory authorities. This risk management plan is to take into account the data benefits on the drug and its potential therapeutic use by women as being of childbearing age. The obtaining of post licence human data is to be built on many players, both private and public, involved in the data collection and evaluation. The setting up of such a network would allow them to join together and optimize their action by standardizing the data collected and their follow up. This should help to generate or rapidly respond to an alert, to conduct collaborative pharmacovigilance pharmacology studies.
Jacqz-Aigrain
Evelyne
E
Pharmacologie Pédiatrique et Pharmacogénétique, Hôpital Robert Debré, Paris, France. evelyne.jacqz-aigrain@rdb.aphp.fr
Lamarque
Véronique
V
D000014:Abnormalities, Drug-Induced / Q000517:prevention & control*; D000328:Adult; D002986:Clinical Trials as Topic / Q000941:ethics / Q000592:standards; D064420:Drug-Related Side Effects and Adverse Reactions; D005060:Europe; D005260:Female; D006801:Humans; D007883:Legislation, Medical; D011247:Pregnancy / Q000502:physiology*; D011358:Product Surveillance, Postmarketing; D012308:Risk Management