注册英语词汇

Glossary术语RegulatoryAffairsRA药政事务drugauthority药政当局investigationandresearchbeforeprojectapproval立项前的调研MarketAuthorizationMA上市许可postapprovalcommitmentstudy上市后的承诺研究postapprovalvariationapplication补充申请lifecycle生命周期ChemistryManufacturingandControlsCMC药品的化学生产和控制crossfunctionalteams公司内部各部门lookatthebigpicture从大局考虑thinkstrategically进行战略性思考risksandbenefits风险和获益FoodandDrugAdministrationFDA美国食品药品监督管理局EuropeanMedicinesAgencyEMA欧洲药品管理局InternationalMulticenterClinicalTrialIMCT国际多中心临床试验BioequivalencestudyBEstud