Global Pharmaceutical and Biologics Regulatory Strategy, Second Edition

Books Member: $160.00 Nonmember: $225.00 AdvancedAdvanced therapies/cell and gene therapyApproval/marketing authorizationBiologics/ biosimilars/ vaccinesCBERCDERClinical TrialsComplianceEuropean Medicines Agency (EMA)ExpertFoundationalGlobalHealth Authority meeting and communication strategyHuman cells, tissues, and cellular and tissue-based products (HCT/Ps)IntermediateManufacturingPharmaceuticalsProduct LifecycleRegulatory harmonizationRegulatory Intelligence/PolicyRegulatory strategyRisk managementUS Food and Drug Administration (FDA)