cfe913f99a301eee5ea7463762ee3f7d pmc_33614746.pdf 7e24de62d065ce045a5e43fa0156cbcfc0a18be1 pmc_33614746.pdf c610029de6145b9b03434ff5f8c2ba82f96b362e5ad57b7ad1703b4957dd400f pmc_33614746.pdf Title: Transitioning From Preclinical Evidence to Advanced Therapy Medicinal Product: A Spanish Experience Subject: A systematic and ordered product development program, in compliance with current quality and regulatory standards, increases the likelihood of yielding a successful advanced therapy medicinal product (ATMP) for clinical use as safe and effective therapy. Keywords: advanced therapy medicinal product, investigational medicinal product, investigational medicinal product dossier (IMPD), translational (regulation), regulatory agency Author: Paloma Gastelurrutia Creator: LaTeX with hyperref package + hypdvips Producer: dvips + MiKTeX GPL Ghostscript 9.0 CreationDate: Mon Feb 1 04:19:50 2021 CET ModDate: Mon Feb 1 05:27:55 2021 CET Tagged: no UserProperties: no Suspects: no Form: none JavaScript: no Pages: 10 Encrypted: no Page size: 595.26 x 779.52 pts Page rot: 0 File size: 1846927 bytes Optimized: no PDF version: 1.6 name type encoding emb sub uni object ID ------------------------------------ ----------------- ---------------- --- --- --- --------- JRBZTL+HelveticaNeueLTStd-Lt Type 1C Custom yes yes no 33 0 PIAOFJ+HelveticaNeueLTStd-BdIt Type 1C WinAnsi yes yes no 46 0 JXKYQR+HelveticaNeueLTStd-LtIt Type 1C Custom yes yes no 48 0 EANHSA+HelveticaNeueLTStd-MdIt Type 1C WinAnsi yes yes no 53 0 KPSHBO+MTSY Type 1C Custom yes yes no 55 0 PICDEQ+MinionPro-Regular Type 1C Custom yes yes no 57 0 ZUERPQ+HelveticaNeueLTStd-Bd Type 1C WinAnsi yes yes no 28 0 XMIBCG+MinionPro-Bold Type 1C Custom yes yes no 79 0 FIRFDQ+HelveticaNeueLTStd-Md Type 1C WinAnsi yes yes no 81 0 JHWNMV+MinionPro-It Type 1C Custom yes yes no 95 0 Jhove (Rel. 1.22.1, 2019-04-17) Date: 2021-09-11 03:45:23 CEST RepresentationInformation: pmc_33614746.pdf ReportingModule: PDF-hul, Rel. 1.12.1 (2019-04-17) LastModified: 2021-04-05 03:37:19 CEST Size: 1846927 Format: PDF Version: 1.6 Status: Well-Formed and valid SignatureMatches: PDF-hul MIMEtype: application/pdf PDFMetadata: Objects: 269 FreeObjects: 15 IncrementalUpdates: 0 DocumentCatalog: ViewerPreferences: HideToolbar: false HideMenubar: false HideWindowUI: false FitWindow: true CenterWindow: false DisplayDocTitle: false NonFullScreenPageMode: UseNone Direction: L2R ViewArea: CropBox ViewClip: CropBox PrintArea: CropBox PageClip: CropBox PageLayout: SinglePage PageMode: UseOutlines Language: en Outlines: Item: Title: Transitioning From Preclinical Evidence to Advanced Therapy Medicinal Product: A Spanish Experience Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@4eb7f003 Children: Item: Title: Introduction Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@eafc191 Item: Title: Sections on Assessment of Policy/Guidelines Options and Implications Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@612fc6eb Children: Item: Title: Four Stages Along the Journey Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@1060b431 Children: Item: Title: Preclinical Stage Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@612679d6 Item: Title: Translational Stage Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@11758f2a Item: Title: Production Stage Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@e720b71 Item: Title: ATMP Approval for Clinical Trials Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@1b26f7b2 Item: Title: Competent Authorities Involved Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@491cc5c9 Children: Item: Title: National Level: Competent Authority Correspondence, Approval Request, and Clinical Trial Registration Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@74ad1f1f Item: Title: European Level: EMA Communication and EU Clinical Trials Registry Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@6a1aab78 Item: Title: Discussion Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@462d5aee Item: Title: Author Contributions Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@69b0fd6f Item: Title: Funding Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@757942a1 Item: Title: Acknowledgments Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@4a87761d Item: Title: References Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@66d1af89 Info: Title: Transitioning From Preclinical Evidence to Advanced Therapy Medicinal Product: A Spanish Experience Author: Paloma Gastelurrutia Subject: A systematic and ordered product development program, in compliance with current quality and regulatory standards, increases the likelihood of yielding a successful advanced therapy medicinal product (ATMP) for clinical use as safe and effective therapy. Keywords: advanced therapy medicinal product, investigational medicinal product, investigational medicinal product dossier (IMPD), translational (regulation), regulatory agency Creator: LaTeX with hyperref package + hypdvips Producer: dvips + MiKTeX GPL Ghostscript 9.0 CreationDate: Mon Feb 01 04:49:50 CET 2021 ModDate: Mon Feb 01 05:57:55 CET 2021 ID: 0xba93a02d917bf33a6f2722bbc24b224a, 0xe246680296a9a342aece61e153d40ce8 Filters: FilterPipeline: FlateDecode FilterPipeline: DCTDecode Images: Image: NisoImageMetadata: FormatName: image/png ImageWidth: 279 ImageHeight: 279 ColorSpace: RGB BitsPerSample: 8 BitsPerSampleUnit: integer Filter: FlateDecode Image: NisoImageMetadata: FormatName: image/jpg CompressionScheme: JPEG ImageWidth: 992 ImageHeight: 1308 ColorSpace: RGB BitsPerSample: 8 BitsPerSampleUnit: integer Interpolate: true Image: NisoImageMetadata: FormatName: image/jpg CompressionScheme: JPEG ImageWidth: 1535 ImageHeight: 1953 ColorSpace: RGB BitsPerSample: 8 BitsPerSampleUnit: integer Interpolate: true Image: NisoImageMetadata: FormatName: image/jpg CompressionScheme: JPEG ImageWidth: 1772 ImageHeight: 756 ColorSpace: RGB BitsPerSample: 8 BitsPerSampleUnit: integer Interpolate: true Image: NisoImageMetadata: FormatName: image/jpg CompressionScheme: JPEG ImageWidth: 1772 ImageHeight: 1357 ColorSpace: RGB BitsPerSample: 8 BitsPerSampleUnit: integer Interpolate: true Image: NisoImageMetadata: FormatName: image/jpg CompressionScheme: JPEG ImageWidth: 1772 ImageHeight: 796 ColorSpace: RGB BitsPerSample: 8 BitsPerSampleUnit: integer Interpolate: true Fonts: Type1: Font: BaseFont: JXKYQR+HelveticaNeueLTStd-LtIt FontSubset: true FirstChar: 0 LastChar: 243 FontDescriptor: FontName: JXKYQR+HelveticaNeueLTStd-LtIt Flags: Symbolic FontBBox: -137, -206, 858, 729 FontFile3: true EncodingDictionary: BaseEncoding: WinAnsiEncoding Differences: true Font: BaseFont: JRBZTL+HelveticaNeueLTStd-Lt FontSubset: true FirstChar: 0 LastChar: 124 FontDescriptor: FontName: JRBZTL+HelveticaNeueLTStd-Lt Flags: Serif, Symbolic FontBBox: -30, -214, 904, 786 FontFile3: true EncodingDictionary: BaseEncoding: WinAnsiEncoding Differences: true Font: BaseFont: FIRFDQ+HelveticaNeueLTStd-Md FontSubset: true FirstChar: 44 LastChar: 121 FontDescriptor: FontName: FIRFDQ+HelveticaNeueLTStd-Md Flags: Nonsymbolic FontBBox: 0, -205, 815, 731 FontFile3: true Encoding: WinAnsiEncoding Font: BaseFont: EANHSA+HelveticaNeueLTStd-MdIt FontSubset: true FirstChar: 42 LastChar: 243 FontDescriptor: FontName: EANHSA+HelveticaNeueLTStd-MdIt Flags: Symbolic FontBBox: -64, -205, 891, 731 FontFile3: true Encoding: WinAnsiEncoding Font: BaseFont: KPSHBO+MTSY FontSubset: true FirstChar: 1 LastChar: 1 FontDescriptor: FontName: KPSHBO+MTSY Flags: Symbolic, AllCap FontBBox: 0, 0, 194, 291 FontFile3: true EncodingDictionary: BaseEncoding: WinAnsiEncoding Differences: true Font: BaseFont: PICDEQ+MinionPro-Regular FontSubset: true FirstChar: 2 LastChar: 246 FontDescriptor: FontName: PICDEQ+MinionPro-Regular Flags: Symbolic FontBBox: -26, -257, 956, 713 FontFile3: true EncodingDictionary: BaseEncoding: WinAnsiEncoding Differences: true Font: BaseFont: ZUERPQ+HelveticaNeueLTStd-Bd FontSubset: true FirstChar: 40 LastChar: 124 FontDescriptor: FontName: ZUERPQ+HelveticaNeueLTStd-Bd Flags: Nonsymbolic FontBBox: -9, -214, 848, 786 FontFile3: true Encoding: WinAnsiEncoding Font: BaseFont: PIAOFJ+HelveticaNeueLTStd-BdIt FontSubset: true FirstChar: 42 LastChar: 121 FontDescriptor: FontName: PIAOFJ+HelveticaNeueLTStd-BdIt Flags: Nonsymbolic FontBBox: -63, -182, 717, 731 FontFile3: true Encoding: WinAnsiEncoding Font: BaseFont: XMIBCG+MinionPro-Bold FontSubset: true FirstChar: 3 LastChar: 118 FontDescriptor: FontName: XMIBCG+MinionPro-Bold Flags: Symbolic FontBBox: -8, -244, 687, 703 FontFile3: true EncodingDictionary: BaseEncoding: WinAnsiEncoding Differences: true Font: BaseFont: JHWNMV+MinionPro-It FontSubset: true FirstChar: 2 LastChar: 243 FontDescriptor: FontName: JHWNMV+MinionPro-It Flags: Symbolic FontBBox: -142, -257, 903, 712 FontFile3: true EncodingDictionary: BaseEncoding: WinAnsiEncoding Differences: true XMP: 2021-02-01T08:49:50+05:30 LaTeX with hyperref package + hypdvips 2021-02-01T09:57:55+05:30 2021-02-01T09:57:55+05:30 application/pdf A systematic and ordered product development program, in compliance with current quality and regulatory standards, increases the likelihood of yielding a successful advanced therapy medicinal product (ATMP) for clinical use as safe and effective therapy. Paloma Gastelurrutia Transitioning From Preclinical Evidence to Advanced Therapy Medicinal Product: A Spanish Experience advanced therapy medicinal product investigational medicinal product investigational medicinal product dossier (IMPD) translational (regulation) regulatory agency advanced therapy medicinal product, investigational medicinal product, investigational medicinal product dossier (IMPD), translational (regulation), regulatory agency dvips + MiKTeX GPL Ghostscript 9.0 uuid:9f1df783-cc67-4c2f-b619-743fc4e7fc98 uuid:593d8583-67db-4775-a3f5-39608dbfbd48 Pages: Page: Label: 1 Annotations: Annotation: Subtype: Link Rect: 43, 719, 229, 755 Annotation: Subtype: Link Rect: 435, 736, 551, 744 Annotation: Subtype: Link Rect: 463, 728, 505, 736 Annotation: Subtype: Link Rect: 505, 728, 533, 736 Annotation: Subtype: Link Rect: 533, 728, 551, 736 Annotation: Subtype: Link Rect: 451, 720, 551, 728 Annotation: Subtype: Link Rect: 521, 678, 551, 709 Annotation: Subtype: Link Rect: 43, 31, 154, 38 Annotation: Subtype: Link Rect: 157, 30, 217, 38 Annotation: Subtype: Link Rect: 423, 29, 551, 38 Annotation: Subtype: Link Rect: 87, 416, 160, 426 Annotation: Subtype: Link Rect: 81, 268, 160, 277 Annotation: Subtype: Link Rect: 74, 69, 160, 76 Annotation: Subtype: Link Rect: 176, 515, 551, 605 Annotation: Subtype: Link Rect: 491, 183, 498, 195 Destination: External Annotation: Subtype: Link Rect: 180, 149, 186, 161 Destination: External Annotation: Subtype: Link Rect: 189, 149, 196, 161 Destination: External Annotation: Subtype: Link Rect: 211, 126, 218, 138 Destination: External Page: Label: 2 Sequence: 2 Annotations: Annotation: Subtype: Link Rect: 250, 614, 257, 625 Destination: External Annotation: Subtype: Link Rect: 260, 614, 267, 625 Destination: External Annotation: Subtype: Link Rect: 189, 579, 196, 591 Destination: External Annotation: Subtype: Link Rect: 133, 430, 139, 442 Destination: External Annotation: Subtype: Link Rect: 251, 419, 262, 430 Destination: External Annotation: Subtype: Link Rect: 82, 373, 93, 385 Destination: External Annotation: Subtype: Link Rect: 47, 224, 58, 236 Destination: External Annotation: Subtype: Link Rect: 61, 224, 72, 236 Destination: External Annotation: Subtype: Link Rect: 189, 178, 200, 190 Destination: External Annotation: Subtype: Link Rect: 244, 155, 255, 167 Destination: External Annotation: Subtype: Link Rect: 375, 627, 386, 639 Destination: External Annotation: Subtype: Link Rect: 389, 627, 400, 639 Destination: External Annotation: Subtype: Link Rect: 501, 559, 512, 570 Destination: External Annotation: Subtype: Link Rect: 404, 490, 415, 501 Destination: External Annotation: Subtype: Link Rect: 43, 30, 154, 38 Annotation: Subtype: Link Rect: 157, 29, 217, 37 Annotation: Subtype: Link Rect: 423, 29, 551, 38 Page: Label: 3 Sequence: 3 Annotations: Annotation: Subtype: Link Rect: 211, 674, 222, 685 Destination: External Annotation: Subtype: Link Rect: 266, 617, 277, 628 Destination: External Annotation: Subtype: Link Rect: 234, 571, 245, 582 Destination: External Annotation: Subtype: Link Rect: 253, 571, 264, 582 Destination: External Annotation: Subtype: Link Rect: 58, 204, 69, 216 Destination: External Annotation: Subtype: Link Rect: 173, 113, 184, 124 Destination: External Annotation: Subtype: Link Rect: 239, 67, 250, 78 Destination: External Annotation: Subtype: Link Rect: 252, 67, 263, 78 Destination: External Annotation: Subtype: Link Rect: 266, 67, 277, 78 Destination: External Annotation: Subtype: Link Rect: 318, 559, 329, 571 Destination: External Annotation: Subtype: Link Rect: 332, 559, 343, 571 Destination: External Annotation: Subtype: Link Rect: 422, 422, 433, 433 Destination: External Annotation: Subtype: Link Rect: 413, 388, 424, 399 Destination: External Annotation: Subtype: Link Rect: 519, 353, 530, 365 Destination: External Annotation: Subtype: Link Rect: 533, 353, 544, 365 Destination: External Annotation: Subtype: Link Rect: 494, 330, 505, 342 Destination: External Annotation: Subtype: Link Rect: 409, 164, 420, 175 Destination: External Annotation: Subtype: Link Rect: 43, 30, 154, 38 Annotation: Subtype: Link Rect: 157, 29, 217, 37 Annotation: Subtype: Link Rect: 423, 29, 551, 38 Page: Label: 4 Sequence: 4 Annotations: Annotation: Subtype: Link Rect: 265, 651, 276, 662 Destination: External Annotation: Subtype: Link Rect: 58, 523, 92, 533 Destination: External Annotation: Subtype: Link Rect: 150, 485, 161, 496 Destination: External Annotation: Subtype: Link Rect: 167, 482, 202, 493 Destination: External Annotation: Subtype: Link Rect: 239, 473, 250, 485 Destination: External Annotation: Subtype: Link Rect: 162, 393, 192, 401 Destination: External Annotation: Subtype: Link Rect: 495, 267, 506, 279 Destination: External Annotation: Subtype: Link Rect: 418, 181, 429, 193 Destination: External Annotation: Subtype: Link Rect: 426, 168, 461, 178 Destination: External Annotation: Subtype: Link Rect: 43, 30, 154, 38 Annotation: Subtype: Link Rect: 157, 29, 217, 37 Annotation: Subtype: Link Rect: 423, 29, 551, 38 Page: Label: 5 Sequence: 5 Annotations: Annotation: Subtype: Link Rect: 344, 354, 355, 365 Destination: External Annotation: Subtype: Link Rect: 408, 64, 443, 75 Destination: External Annotation: Subtype: Link Rect: 43, 30, 154, 38 Annotation: Subtype: Link Rect: 157, 29, 217, 37 Annotation: Subtype: Link Rect: 423, 29, 551, 38 Page: Label: 6 Sequence: 6 Annotations: Annotation: Subtype: Link Rect: 86, 133, 170, 144 Annotation: Subtype: Link Rect: 179, 133, 214, 143 Destination: External Annotation: Subtype: Link Rect: 255, 124, 266, 136 Destination: External Annotation: Subtype: Link Rect: 210, 53, 244, 64 Destination: External Annotation: Subtype: Link Rect: 252, 56, 263, 67 Destination: External Annotation: Subtype: Link Rect: 477, 144, 551, 155 Annotation: Subtype: Link Rect: 304, 134, 316, 143 Annotation: Subtype: Link Rect: 43, 30, 154, 38 Annotation: Subtype: Link Rect: 157, 29, 217, 37 Annotation: Subtype: Link Rect: 423, 29, 551, 38 Page: Label: 7 Sequence: 7 Annotations: Annotation: Subtype: Link Rect: 351, 67, 358, 79 Destination: External Annotation: Subtype: Link Rect: 43, 30, 154, 38 Annotation: Subtype: Link Rect: 157, 29, 217, 37 Annotation: Subtype: Link Rect: 423, 29, 551, 38 Page: Label: 8 Sequence: 8 Annotations: Annotation: Subtype: Link Rect: 43, 413, 255, 424 Annotation: Subtype: Link Rect: 253, 101, 264, 113 Destination: External Annotation: Subtype: Link Rect: 534, 450, 546, 461 Destination: External Annotation: Subtype: Link Rect: 304, 436, 338, 446 Destination: External Annotation: Subtype: Link Rect: 43, 30, 154, 38 Annotation: Subtype: Link Rect: 157, 29, 217, 37 Annotation: Subtype: Link Rect: 423, 29, 551, 38 Page: Label: 9 Sequence: 9 Annotations: Annotation: Subtype: Link Rect: 191, 488, 273, 496 Annotation: Subtype: Link Rect: 129, 460, 238, 467 Annotation: Subtype: Link Rect: 81, 432, 185, 439 Annotation: Subtype: Link Rect: 81, 402, 174, 411 Annotation: Subtype: Link Rect: 101, 364, 189, 373 Annotation: Subtype: Link Rect: 180, 326, 265, 335 Annotation: Subtype: Link Rect: 126, 279, 205, 288 Annotation: Subtype: Link Rect: 267, 269, 291, 278 Annotation: Subtype: Link Rect: 57, 260, 278, 269 Annotation: Subtype: Link Rect: 57, 250, 149, 259 Annotation: Subtype: Link Rect: 128, 231, 291, 241 Annotation: Subtype: Link Rect: 57, 222, 273, 231 Annotation: Subtype: Link Rect: 57, 212, 115, 222 Annotation: Subtype: Link Rect: 142, 186, 218, 193 Annotation: Subtype: Link Rect: 81, 138, 154, 146 Annotation: Subtype: Link Rect: 292, 90, 56, 109 Annotation: Subtype: Link Rect: 341, 517, 415, 525 Annotation: Subtype: Link Rect: 364, 477, 454, 487 Annotation: Subtype: Link Rect: 390, 430, 469, 439 Annotation: Subtype: Link Rect: 552, 382, 316, 402 Annotation: Subtype: Link Rect: 351, 346, 438, 354 Annotation: Subtype: Link Rect: 368, 307, 448, 316 Annotation: Subtype: Link Rect: 354, 279, 433, 288 Annotation: Subtype: Link Rect: 317, 250, 477, 259 Annotation: Subtype: Link Rect: 375, 214, 436, 221 Annotation: Subtype: Link Rect: 365, 184, 454, 193 Annotation: Subtype: Link Rect: 417, 167, 479, 174 Annotation: Subtype: Link Rect: 338, 127, 417, 136 Annotation: Subtype: Link Rect: 354, 72, 439, 79 Annotation: Subtype: Link Rect: 43, 29, 154, 37 Annotation: Subtype: Link Rect: 157, 28, 217, 36 Annotation: Subtype: Link Rect: 423, 28, 551, 37 Page: Label: 10 Sequence: 10 Annotations: Annotation: Subtype: Link Rect: 118, 687, 291, 697 Annotation: Subtype: Link Rect: 57, 678, 274, 687 Annotation: Subtype: Link Rect: 57, 669, 226, 678 Annotation: Subtype: Link Rect: 57, 612, 143, 621 Annotation: Subtype: Link Rect: 205, 584, 291, 593 Annotation: Subtype: Link Rect: 57, 574, 286, 583 Annotation: Subtype: Link Rect: 239, 546, 291, 555 Annotation: Subtype: Link Rect: 57, 536, 111, 545 Annotation: Subtype: Link Rect: 489, 697, 551, 706 Annotation: Subtype: Link Rect: 317, 687, 542, 697 Annotation: Subtype: Link Rect: 317, 678, 330, 687 Annotation: Subtype: Link Rect: 476, 650, 551, 659 Annotation: Subtype: Link Rect: 317, 640, 533, 649 Annotation: Subtype: Link Rect: 317, 631, 381, 640 Annotation: Subtype: Link Rect: 524, 566, 551, 573 Annotation: Subtype: Link Rect: 304, 556, 336, 563 Annotation: Subtype: Link Rect: 336, 556, 372, 564 Annotation: Subtype: Link Rect: 373, 556, 396, 563 Annotation: Subtype: Link Rect: 397, 555, 425, 564 Annotation: Subtype: Link Rect: 43, 30, 154, 38 Annotation: Subtype: Link Rect: 157, 29, 217, 37 Annotation: Subtype: Link Rect: 423, 29, 551, 38 Checksum: c412a645 Type: CRC32 Checksum: cfe913f99a301eee5ea7463762ee3f7d Type: MD5 Checksum: 7e24de62d065ce045a5e43fa0156cbcfc0a18be1 Type: SHA-1