根据仿制药用户费用修正案 (GDUFA) III 管理药品评估员的项目-Tawwab.pdf

1、Project Managing Drug Assessors Under Generic Drug User Fee Amendment(GDUFA)III RegulationsNuri Tawwab,PharmD,MPHLCDR,U.S.Public Health ServiceStakeholder Engagement TeamDivision of Prevention Communication and Public Engagement(DPCPE)Center for Substance Abuse Prevention(CSAP)|Substance Abuse and M

2、ental HealthServices Administration(SAMHSA)Project Managing Drug Assessors Under GDUFA III Regulations10903 New Hampshire Ave,Bld 75 Rm 4611Silver Spring,MD 209932LCDR Nuri Tawwab Educational BackgroundPharmacistHampton University School of PharmacyEmory University:Rollins School of Public HealthCon

3、centration in prevention science Project Managing Drug Assessors Under GDUFA III Regulations3Career in the Government Commissioned officer in the United States Public Health Service Started as a Pharmacist at the Indian Health Service in 2012 in Kayenta,Arizona Junior COSTEP in 2011 Senior COSTEP in

4、 2012 Transferred to the FDA in 2015 to become a Regulatory Business Process Manager(RBPM)in OPQ The Office of Pharmaceutical Qualitys(OPQ)mission is to assure that quality medicines are available for the American public.Project Managing Drug Assessors Under GDUFA III Regulations4Current Job RoleReg

5、ulatory Business Process Manager POC for communication related to drug product quality or facility status information to the drug firms.Information request(IR)letters Discipline review letters(DRL)Manage the lifecycle of drugs via a team-based Integrated Quality Assessment(IQA)model.IQA aligns patie

6、nt-focused and risk-based drug product quality recommendations.It encompasses new drug applications(NDAs),abbreviated new drug applications(ANDAs)The congressional mandate that we follow when managing these applications or projects is called the Generic Drug User Fee Amendments(GDUFA).Project Managi