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Keywords: genetic therapy, tissue engineering, cell- and tissue-based therapy, biological products, biological therapy, legislation and jurisprudence, United States Food and Drug Administration, Europe Author: Carolina Iglesias-López Creator: Adobe InDesign CC 2015 (Windows) Producer: Adobe PDF Library 15.0 CreationDate: Wed Aug 28 19:42:25 2019 CEST ModDate: Wed Aug 28 20:02:34 2019 CEST Tagged: yes UserProperties: no Suspects: no Form: none JavaScript: no Pages: 14 Encrypted: no Page size: 595.276 x 779.528 pts Page rot: 0 File size: 1034536 bytes Optimized: no PDF version: 1.4 name type encoding emb sub uni object ID ------------------------------------ ----------------- ---------------- --- --- --- --------- HelveticaNeueLTStd-Bd Type 1C Custom yes no yes 1715 0 HelveticaNeueLTStd-Lt Type 1C Custom yes no yes 1716 0 HelveticaNeueLTStd-MdIt Type 1C WinAnsi yes no yes 1728 0 HelveticaNeueLTStd-LtIt Type 1C Custom yes no yes 1729 0 MinionPro-Regular Type 1C Custom yes no yes 1741 0 FYXEXE+STIXGeneral Type 1C WinAnsi yes yes yes 1740 0 HelveticaNeueLTStd-BdIt Type 1C WinAnsi yes no yes 1743 0 MinionPro-It Type 1C Custom yes no yes 133 0 MinionPro-Bold Type 1C Custom yes no yes 178 0 HelveticaNeueLTStd-Md Type 1C WinAnsi yes no yes 272 0 Jhove (Rel. 1.22.1, 2019-04-17) Date: 2020-08-10 12:27:50 CEST RepresentationInformation: pmc_31543814.pdf ReportingModule: PDF-hul, Rel. 1.12.1 (2019-04-17) LastModified: 2020-03-02 03:57:24 CET Size: 1034536 Format: PDF Version: 1.4 Status: Well-Formed, but not valid SignatureMatches: PDF-hul ID: PDF-HUL-122 ErrorMessage: edu.harvard.hul.ois.jhove.module.pdf.PdfInvalidException: Invalid indirect destination - referenced object 'fphar.2019.00921.indd:European Union. Directive 2010:5845' cannot be found Offset: 929796 MIMEtype: application/pdf PDFMetadata: Objects: 1797 FreeObjects: 2178 IncrementalUpdates: 5 DocumentCatalog: ViewerPreferences: HideToolbar: false HideMenubar: false HideWindowUI: false FitWindow: false CenterWindow: false DisplayDocTitle: false NonFullScreenPageMode: UseNone Direction: L2R ViewArea: CropBox ViewClip: CropBox PrintArea: CropBox PageClip: CropBox PageLayout: SinglePage PageMode: UseOutlines Outlines: Item: Title: Regulatory Framework for Advanced Therapy Medicinal Products in Europe and United States Children: Item: Title: Introduction Item: Title: Regulatory Framework for the Classification of Advanced Therapies Item: Title: Classification Criteria in Europe and United States Children: Item: Title: Gene Therapies Item: Title: Cell and Tissue Therapies Children: Item: Title: Manipulation and Homologous Use Item: Title: Combined Advanced Therapy Medicinal Products Item: Title: General Discussion and Conclusion Item: Title: Author Contributions Item: Title: References Info: Title: Regulatory Framework for Advanced Therapy Medicinal Products in Europe and United States Author: Carolina Iglesias-López Subject: Advanced therapy medicinal products (ATMPs) are a fast-growing field of innovative therapies. Keywords: genetic therapy, tissue engineering, cell- and tissue-based therapy, biological products, biological therapy, legislation and jurisprudence, United States Food and Drug Administration, Europe Creator: Adobe InDesign CC 2015 (Windows) Producer: Adobe PDF Library 15.0 CreationDate: Wed Aug 28 19:42:25 CEST 2019 ModDate: Wed Aug 28 20:02:34 CEST 2019 ID: 0xa25fed86dcf3fe479d88dd45f92bf3e9, 0xbf1cc67a19839140ad22c0f97f357d22 Filters: FilterPipeline: FlateDecode Fonts: Type1: Font: BaseFont: HelveticaNeueLTStd-MdIt FirstChar: 0 LastChar: 255 FontDescriptor: FontName: HelveticaNeueLTStd-MdIt Flags: Nonsymbolic, Italic FontBBox: -165, -218, 1125, 947 FontFile3: true Encoding: WinAnsiEncoding ToUnicode: true Font: BaseFont: HelveticaNeueLTStd-Md FirstChar: 0 LastChar: 255 FontDescriptor: FontName: HelveticaNeueLTStd-Md Flags: Nonsymbolic FontBBox: -165, -221, 1066, 952 FontFile3: true Encoding: WinAnsiEncoding ToUnicode: true Font: BaseFont: HelveticaNeueLTStd-LtIt FirstChar: 0 LastChar: 255 FontDescriptor: FontName: HelveticaNeueLTStd-LtIt Flags: Nonsymbolic, Italic FontBBox: -165, -214, 1099, 951 FontFile3: true EncodingDictionary: BaseEncoding: WinAnsiEncoding Differences: true ToUnicode: true Font: BaseFont: MinionPro-Bold FirstChar: 0 LastChar: 255 FontDescriptor: FontName: MinionPro-Bold Flags: Serif, Nonsymbolic FontBBox: -319, -360, 1684, 1024 FontFile3: true EncodingDictionary: BaseEncoding: WinAnsiEncoding Differences: true ToUnicode: true Font: BaseFont: HelveticaNeueLTStd-Bd FirstChar: 0 LastChar: 255 FontDescriptor: FontName: HelveticaNeueLTStd-Bd Flags: Nonsymbolic FontBBox: -166, -218, 1078, 975 FontFile3: true EncodingDictionary: BaseEncoding: WinAnsiEncoding Differences: true ToUnicode: true Font: BaseFont: HelveticaNeueLTStd-Lt FirstChar: 0 LastChar: 255 FontDescriptor: FontName: HelveticaNeueLTStd-Lt Flags: Nonsymbolic FontBBox: -166, -214, 1050, 967 FontFile3: true EncodingDictionary: BaseEncoding: WinAnsiEncoding Differences: true ToUnicode: true Font: BaseFont: MinionPro-It FirstChar: 0 LastChar: 255 FontDescriptor: FontName: MinionPro-It Flags: Serif, Nonsymbolic, Italic FontBBox: -201, -360, 1684, 1002 FontFile3: true EncodingDictionary: BaseEncoding: WinAnsiEncoding Differences: true ToUnicode: true Font: BaseFont: FYXEXE+STIXGeneral FontSubset: true FirstChar: 174 LastChar: 174 FontDescriptor: FontName: FYXEXE+STIXGeneral Flags: Serif, Nonsymbolic FontBBox: -178, -443, 2000, 1023 FontFile3: true Encoding: WinAnsiEncoding ToUnicode: true Font: BaseFont: MinionPro-Regular FirstChar: 0 LastChar: 255 FontDescriptor: FontName: MinionPro-Regular Flags: Serif, Nonsymbolic FontBBox: -290, -360, 1684, 989 FontFile3: true EncodingDictionary: BaseEncoding: WinAnsiEncoding Differences: true ToUnicode: true Font: BaseFont: HelveticaNeueLTStd-BdIt FirstChar: 0 LastChar: 255 FontDescriptor: FontName: HelveticaNeueLTStd-BdIt Flags: Nonsymbolic, Italic FontBBox: -166, -218, 1129, 975 FontFile3: true Encoding: WinAnsiEncoding ToUnicode: true XMP: application/pdf Regulatory Framework for Advanced Therapy Medicinal Products in Europe and United States Advanced therapy medicinal products (ATMPs) are a fast-growing field of innovative therapies. Carolina Iglesias-López Antonia Agustí Mercè Obach Antonio Vallano genetic therapy tissue engineering cell- and tissue-based therapy biological products biological therapy legislation and jurisprudence United States Food and Drug Administration Europe 2019-08-29T01:42:25+08:00 2019-08-29T02:02:34+08:00 2019-08-29T02:02:34+08:00 Adobe InDesign CC 2015 (Windows) uuid:76d320aa-8ea6-477d-8e81-c7b9278462a7 xmp.did:2aecd8bd-cbd3-4539-b083-9de383973cbe xmp.id:1f1078c5-af25-6d45-9b42-09af071204bb proof:pdf xmp.iid:cff416cd-dfe2-3e44-b380-ec912d86eda3 xmp.did:c5b2faf7-74d8-fc4f-8159-2a338f8fe2f3 xmp.did:2aecd8bd-cbd3-4539-b083-9de383973cbe default converted from application/x-indesign to application/pdf Adobe InDesign CC 2015 (Windows) / 2019-08-29T01:42:25+08:00 Adobe PDF Library 15.0 False genetic therapy, tissue engineering, cell- and tissue-based therapy, biological products, biological therapy, legislation and jurisprudence, United States Food and Drug Administration, Europe Pages: Page: 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549, 671 Annotation: Subtype: Link Rect: 315, 671, 528, 661 Annotation: Subtype: Link Rect: 408, 652, 549, 642 Annotation: Subtype: Link Rect: 315, 643, 545, 633 Annotation: Subtype: Link Rect: 409, 624, 549, 614 Annotation: Subtype: Link Rect: 315, 614, 473, 604 Annotation: Subtype: Link Rect: 461, 595, 549, 585 Annotation: Subtype: Link Rect: 315, 586, 474, 576 Annotation: Subtype: Link Rect: 454, 520, 549, 509 Annotation: Subtype: Link Rect: 305, 510, 360, 500 Checksum: d66a7c34 Type: CRC32 Checksum: 6b9c493e6f078d643704901d67d56e11 Type: MD5 Checksum: fa30f876ca7f87f9226664f9f8d35aace335a5eb Type: SHA-1