Fundamentals of Pharmaceutical and Biologics Regulations: A Global Perspective

Books Member: $295 | Student Member: $195 | Emerging Member: $158 | Nonmember: $395 AdvancedAdvanced manufacturingAdvanced therapies/cell and gene therapyAntimicrobial resistanceApproval/marketing authorizationBiologics License Application (BLA)Biologics/ biosimilars/ vaccinesBsUFACBERCDERContinuous manufacturingCTD/eCTDDecentralized clinical trialsDrug master file (DMF)DSCSAEuropean Medicines Agency (EMA)ExpertFoundationalGDUFAGlobalGuidanceICMRAIntermediateMDUFAMedical countermeasures (MCM)NitrosaminesOrphan drugsPDUFAPharmaceuticalsPharmacovigilance/postmarket surveillanceProduct developmentProduct LifecycleRisk managementRWE/RWD