International Conference on Harmonisation; guidance on E2E Pharmacovigilance Planning; availability. Notice.
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "E2E Pharmacovigilance Planning." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes a method for summarizing the important potential and identified risks of a drug. It proposes a structure for a pharmacovigilance plan and sets out principles of good practice for the design and conduct of observational studies. The guidance is intended to aid in planning pharmacovigilance activities, especially in preparation for the early postmarketing period of a new drug.
D003226:Congresses as Topic; D064420:Drug-Related Side Effects and Adverse Reactions; D005060:Europe; D005062:European Union; D017408:Guidelines as Topic; D006801:Humans; D007373:Interinstitutional Relations; D007391:International Cooperation; D007564:Japan; D004364:Pharmaceutical Preparations / Q000592:standards*; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration
D004364:Pharmaceutical Preparations