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dc.date.accessioned2019-09-20T19:45:53Z
dc.date.available2019-09-20T19:45:53Z
dc.date.issued2019-09-20
dc.identifier.citationPan American Health Organization. Regulation of Advanced Therapy Medicinal Products: Concept Note and Recommendations. Ninth Conference of the Pan American Network for Drug Regulatory Harmonization (PANDRH). (San Salvador, October 2018). Washington, D.C.: PAHO; 2019.en_US
dc.identifier.govdocPAHO/HSS/19-004
dc.identifier.urihttps://iris.paho.org/handle/10665.2/51558
dc.description.abstractThe aim of this document is to highlight the progress made with regard to advanced therapy products, the risks associated with such products, and the regulatory challenges they pose for Member States with a view to strengthening regulatory systems. The document is also a call to action for governments to consider the development of standards and rules for regulating these products in order to control the use of unapproved therapies and prevent risks to the population. As discussed, there are cross-cutting regulatory principles that should be implemented by any regulatory body that plans to undertake the regulation and oversight of advanced therapy products.en_US
dc.language.isoenen_US
dc.publisherPAHOen_US
dc.subjectPharmaceutical Servicesen_US
dc.subjectHealth Systemsen_US
dc.subjectPharmacyen_US
dc.subjectPharmacovigilance
dc.subjectHematopoietic Stem Cells
dc.subjectImmune System
dc.subjectHemic and Immune Systemsen_US
dc.titleRegulation of Advanced Therapy Medicinal Products: Concept Note and Recommendations. Ninth Conference of the Pan American Network for Drug Regulatory Harmonization (PANDRH). (San Salvador, October 2018)en_US
dc.typeMeeting reportsen_US
dc.rights.holderPan American Health Organizationen_US
dc.contributor.corporatenamePan American Health Organizationen_US
paho.isfeatured0en_US
paho.publisher.countryUnited Statesen_US
paho.publisher.cityWashington, D. C.en_US
paho.source.centercodeUS1.1en_US
paho.subjectCat 4. Health Systemsen_US
paho.relation.languageVersion10665.2/51557
paho.contributor.departmentHealth Systems and Services (HSS)en_US
paho.iswhotranslationNoen_US


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