Pharmaceutical Technology - September 2019

Pharmaceutical Technology - Regulatory Sourcebook

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PDA: Shaping the Global Regulatory Landscape PDA lives its motto – Connecting People, Science, and Regulation ® – every day through our engagement with health authorities and pharmacopeias around the world. In harmony with our consensus-driven, peer-reviewed Technical Reports, PDA members collaborate in Commenting Teams to develop responses to draft regulations and KYMHERGIWXLEXVIƽIGXSYVZMWMSRSJQE\MQM^MRKTVSHYGXUYEPMX]EZEMPEFMPMX]ERHZEPYI • ;IEHZSGEXIJSVKPSFEPLEVQSRM^EXMSRWMQTPMƼGEXMSRERHIƾGMIRG]MRXLI regulations that impact the manufacturing science of pharmaceuticals, FMSTLEVQEGIYXMGEPWERHEHZERGIHXLIVETMIW,EVQSRM^EXMSRSJVIKYPEXSV] VIUYMVIQIRXWƂMRFSXLXI\XERHETTPMGEXMSRƂGERHVMZIMRRSZEXMSRUYEPMX] performance, and compliance. • We help guide regulators on emerging science and technology topics. As the industry continues to shift from traditional pharmaceuticals and biologics to novel therapies, and as manufacturing technology advances, PDA can identify and help health EYXLSVMXMIWVIWSPZIVIEP[SVPHMQTPIQIRXEXMSRUYIWXMSRWFIJSVIXLI]MQTEGXTEXMIRXW 4(%MWYRMUYIP]TSWMXMSRIHXSLIPTVIKYPEXSVWGVIEXI[SVOEFPIERHMRRSZEXMZI VIKYPEXSV]WSPYXMSRWXLEXTVSXIGXTVSHYGXUYEPMX]ERHEZEMPEFMPMX];MXLQSVIXLER 10,500 members and 26 chapters globally, PDA can gather diverse perspectives on VIKYPEXSV]MRMXMEXMZIWERHGERGSRRIGXVIKYPEXSVWERHI\TIVXWSRXSTMGWXLEXMQTEGX QERYJEGXYVMRKWGMIRGI4(%WYGGIIHWFIGEYWISJXLILEVH[SVOHIXIVQMREXMSRERH diversity of its volunteers and members. %WE4(%QIQFIV]SYEVIMRZMXIHXSTEVXMGMTEXIMRSYVGSQQIRXMRKXIEQW8SƼRHSYXLS[ • )\TPSVISYVZSPYRXIIVSTTSVXYRMXMIWEX • Visit to join one of our Interest Groups PDA's past regulatory comments are on our website at

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