[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-detail-168825-en":3,"doc-seo-168825-105":30,"detail-sidebar-cat-1-en-105":83},{"code":4,"msg":5,"data":6},0,"success",{"doc_id":7,"user_id":8,"nickname":9,"user_avatar":10,"doc_module":11,"category_id":12,"category_name":13,"doc_title":14,"doc_description":15,"doc_content":16,"file_id":17,"file_url":18,"file_type":19,"file_size":20,"view_count":4,"is_deleted":4,"is_public":11,"is_downloadable":11,"audit_status":11,"page_count":21,"language":22,"language_code":23,"site_id":24,"html_lang":23,"table_of_contents":25,"faqs":26,"seo_title":27,"seo_description":15,"update_tm":28,"read_time":29},168825,4398048950312,"Violet","https://ap-avatar.wpscdn.com/avatar/400002538284de19e3c?_k=1778320343897328908",1,11,"Presentations","Scientific Document - For paediatric investigation plan or product-specific waiver - Table of contents","Template Version 4 provides a structured outline for submitting a paediatric investigation plan or a product-specific waiver, aligned with EMA requirements. It specifies formatting rules for text, tables, and inserted figures, and instructs applicants to keep all template styles and EMA comment boxes unchanged. The included table of contents covers application details, overview of disease and pharmacological rationale, waiver grounds and conclusions, and the proposed paediatric investigation plan across quality, non-clinical, and clinical sections.","Template Version 4\nScientific document\nFor paediatric investigation plan or product-specific waiver\n\u003CActive substance(s)>\n\u003CCase number> - Include case number before uploading this document (e.g. EMA/PE/0000123456)\nPlease use this template for your submission ensuring that all information in this document is the same as entered in the IRIS submission.\nDo not amend the style of the template; keep existing fonts and headings when completing. Do not delete or amend text in headings and keep all Comment boxes for EMA use without changes.\nYou may add “Not applicable” when and where necessary\nKeep the format as set in the document to Font Verdana 9\nParagraph tab:\nAlignment: left\nOutline level: body text\nIndentation: 0\nSpacing: Before: 0pt, After: 7pt; Line spacing: At least, At: 14pt\nInserting tables: Please use plain table and where possible in portrait layout.\nInserting pictures and figures: Keep the document flowing.\nDo not use section breaks (unless your table can not fit in portrait layout).\nDo not use links, fields, and citations; keep the document free of footnotes and endnotes.\nTable of contents\n\u0013 TOC \\o \"1-3\" \\h \\z \\u \u0014\u0013 HYPERLINK \\l \"_Toc226468168\" \u0014Table of contents\t\u0013 PAGEREF _Toc226468168 \\h \u00142\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc226468169\" \u0014Abbreviations\t\u0013 PAGEREF _Toc226468169 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc226468170\" \u00141. Application details\t\u0013 PAGEREF _Toc226468170 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc226468171\" \u0014Applicant’s summary\t\u0013 PAGEREF _Toc226468171 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc226468172\" \u0014This page is for EMA use only (do not amend or delete)\t\u0013 PAGEREF _Toc226468172 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc226468173\" \u0014Administrative summary\t\u0013 PAGEREF _Toc226468173 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc226468174\" \u0014Comments\t\u0013 PAGEREF _Toc226468174 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc226468175\" \u00142. Overview of the disease(s), condition and pharmacological rationale\t\u0013 PAGEREF _Toc226468175 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc226468176\" \u00142.1. Pharmacology and mechanism of action\t\u0013 PAGEREF _Toc226468176 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc226468177\" \u00142.2. Summary of differences/similarities in the condition between populations (e.g. adult vs paediatric)\t\u0013 PAGEREF _Toc226468177 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc226468178\" \u00142.3. Current methods of diagnosis, prevention, or treatment in paediatric populations\t\u0013 PAGEREF _Toc226468178 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc226468179\" \u0014Non- authorised or off-label medicinal products in the proposed condition\t\u0013 PAGEREF _Toc226468179 \\h \u00149\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc226468180\" \u0014Authorised medicinal products in the proposed condition\t\u0013 PAGEREF _Toc226468180 \\h \u00149\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc226468181\" \u00142.4. Description of the fulfilment of therapeutic needs and/or significant therapeutic benefit\t\u0013 PAGEREF _Toc226468181 \\h \u00149\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc226468182\" \u00142.5. Proposed indication(s) in relation to the proposed condition and selected paediatric subsets\t\u0013 PAGEREF _Toc226468182 \\h \u001410\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc226468183\" \u00142.6. Summary of regulatory advice\t\u0013 PAGEREF _Toc226468183 \\h \u001411\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc226468184\" \u00142.7. Feedback received from networks, experts and patient groups\t\u0013 PAGEREF _Toc226468184 \\h \u001411\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc226468185\" \u0014Comments\t\u0013 PAGEREF _Toc226468185 \\h \u001412\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc226468186\" \u00143. Application for waiver(s)\t\u0013 PAGEREF _Toc226468186 \\h \u001414\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc226468187\" \u00143.1. Overview\t\u0013 PAGEREF _Toc226468187 \\h \u001414\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc226468188\" \u00143.2. Ground a: the specific medicinal product is likely to be ineffective or unsafe\t\u0013 PAGEREF _Toc226468188 \\h \u001415\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc226468189\" \u00143.3. Ground b: the disease or condition for which the specific medicinal product is intended does not occur in the specified paediatric subset(s)\t\u0013 PAGEREF _Toc226468189 \\h \u001416\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc226468190\" \u00143.4. Ground c: the specific medicinal product does not represent a significant therapeutic benefit\t\u0013 PAGEREF _Toc226468190 \\h \u001416\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc226468191\" \u00143.5. Conclusion\t\u0013 PAGEREF _Toc226468191 \\h \u001416\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc226468192\"","cbCainoCcPrbPUNg","https://ap.wps.com/l/cbCainoCcPrbPUNg","docx",282962,46,"English","en",105,"# Table of contents\n## Abbreviations\n## 1. Application details\n## Applicant’s summary\n## This page is for EMA use only (do not amend or delete)\n## Administrative summary\n## Comments\n## 2. Overview of the disease(s), condition and pharmacological rationale\n## 3. Application for waiver(s)\n## 3.1. Overview\n## 3.2. Ground a: the specific medicinal product is likely to be ineffective or unsafe\n## 3.3. Ground b: the disease or condition for which the specific medicinal product is intended does not occur in the specified paediatric subset(s)\n## 3.4. Ground c: the specific medicinal product does not represent a significant therapeutic benefit\n## 3.5. Conclusion\n## 4. Proposed paediatric investigation plan\n## 4.1. Quality aspects\n## 4.2. Non-clinical aspects\n## 4.3. Clinical aspects","[{\"question\":\"How should tables and figures be handled in the template?\",\"answer\":\"Tables should be plain and, where possible, in portrait layout. Inserted pictures and figures should keep the document flowing without disrupting the prescribed format.\"}]","Scientific Document - For paediatric investigation plan or product-specific waiver - Table of contents | DOCX",1788238524,16,{"code":4,"msg":31,"data":32},"ok",{"site_id":24,"language":23,"slug":33,"title":14,"keywords":34,"description":15,"schema_data":35,"social_meta":78,"head_meta":80,"extra_data":82,"updated_unix":28},"scientific-document-for-paediatric-investigation-plan-or-product-specific-waiver-table-of-contents","",{"@graph":36,"@context":77},[37,54,68],{"@type":38,"itemListElement":39},"BreadcrumbList",[40,44,48,51],{"item":41,"name":42,"@type":43,"position":11},"https://docshare.wps.com","Home","ListItem",{"item":45,"name":46,"@type":43,"position":47},"https://docshare.wps.com/template/","Template",2,{"item":49,"name":13,"@type":43,"position":50},"https://docshare.wps.com/template/presentations/",3,{"item":52,"name":14,"@type":43,"position":53},"https://docshare.wps.com/template/scientific-document-for-paediatric-investigation-plan-or-product-specific-waiver-table-of-contents/168825/",4,{"url":52,"name":14,"@type":55,"author":56,"headline":14,"publisher":58,"fileFormat":61,"inLanguage":23,"description":15,"dateModified":62,"datePublished":62,"encodingFormat":61,"isAccessibleForFree":63,"interactionStatistic":64},"DigitalDocument",{"name":9,"@type":57},"Person",{"url":41,"name":59,"@type":60},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-09-01",true,{"@type":65,"interactionType":66,"userInteractionCount":11},"InteractionCounter",{"@type":67},"ViewAction",{"@type":69,"mainEntity":70},"FAQPage",[71],{"name":72,"@type":73,"acceptedAnswer":74},"How should tables and figures be handled in the template?","Question",{"text":75,"@type":76},"Tables should be plain and, where possible, in portrait layout. Inserted pictures and figures should keep the document flowing without disrupting the prescribed format.","Answer","https://schema.org",{"og:url":52,"og:type":79,"og:title":14,"og:site_name":59,"og:description":15},"article",{"robots":81,"canonical":52},"index,follow",{"doc_id":7,"site_id":24},{"code":4,"msg":5,"data":84},[85,88,93,98,103,107,112,117,122],{"id":12,"doc_module":11,"doc_module_name":46,"category_name":13,"show_sort_weight":86,"slug":87},90,"presentations",{"id":89,"doc_module":11,"doc_module_name":46,"category_name":90,"show_sort_weight":91,"slug":92},12,"Resumes",80,"resumes",{"id":94,"doc_module":11,"doc_module_name":46,"category_name":95,"show_sort_weight":96,"slug":97},14,"Invoices",70,"invoices",{"id":99,"doc_module":11,"doc_module_name":46,"category_name":100,"show_sort_weight":101,"slug":102},15,"Posters",60,"posters",{"id":29,"doc_module":11,"doc_module_name":46,"category_name":104,"show_sort_weight":105,"slug":106},"Social Media",50,"social-media",{"id":108,"doc_module":11,"doc_module_name":46,"category_name":109,"show_sort_weight":110,"slug":111},17,"Forms",40,"forms",{"id":113,"doc_module":11,"doc_module_name":46,"category_name":114,"show_sort_weight":115,"slug":116},18,"Letters",30,"letters",{"id":118,"doc_module":11,"doc_module_name":46,"category_name":119,"show_sort_weight":120,"slug":121},21,"Paper Templates",5,"papers-templates",{"id":123,"doc_module":11,"doc_module_name":46,"category_name":124,"show_sort_weight":4,"slug":125},158,"General","general-158"]