screenshots gallery selected screenshots of regulatory ... · the ctd triangle. the common...
TRANSCRIPT
![Page 1: Screenshots Gallery Selected screenshots of regulatory ... · The CTD triangle. The Common Technical Document is organized into five modules. Module 1 is region specific and modules](https://reader031.vdocuments.mx/reader031/viewer/2022041914/5e68bc937196eb58f33c9a9d/html5/thumbnails/1.jpg)
Screenshots Gallery
Selected screenshots of regulatory documents
![Page 2: Screenshots Gallery Selected screenshots of regulatory ... · The CTD triangle. The Common Technical Document is organized into five modules. Module 1 is region specific and modules](https://reader031.vdocuments.mx/reader031/viewer/2022041914/5e68bc937196eb58f33c9a9d/html5/thumbnails/2.jpg)
Annotated Case Report Form (Source: Zanamivir trial NAI30031, ACRF Contact, PDF
p. 6)
![Page 3: Screenshots Gallery Selected screenshots of regulatory ... · The CTD triangle. The Common Technical Document is organized into five modules. Module 1 is region specific and modules](https://reader031.vdocuments.mx/reader031/viewer/2022041914/5e68bc937196eb58f33c9a9d/html5/thumbnails/3.jpg)
Blank Case Report Form (Source: Oseltamivir trial NV16871 PDF pp. 336-527)
![Page 4: Screenshots Gallery Selected screenshots of regulatory ... · The CTD triangle. The Common Technical Document is organized into five modules. Module 1 is region specific and modules](https://reader031.vdocuments.mx/reader031/viewer/2022041914/5e68bc937196eb58f33c9a9d/html5/thumbnails/4.jpg)
Case Report Form (Source: Arthronat trial MA-CT-10-002 PDF pp. 3988-3989)
![Page 5: Screenshots Gallery Selected screenshots of regulatory ... · The CTD triangle. The Common Technical Document is organized into five modules. Module 1 is region specific and modules](https://reader031.vdocuments.mx/reader031/viewer/2022041914/5e68bc937196eb58f33c9a9d/html5/thumbnails/5.jpg)
![Page 6: Screenshots Gallery Selected screenshots of regulatory ... · The CTD triangle. The Common Technical Document is organized into five modules. Module 1 is region specific and modules](https://reader031.vdocuments.mx/reader031/viewer/2022041914/5e68bc937196eb58f33c9a9d/html5/thumbnails/6.jpg)
![Page 7: Screenshots Gallery Selected screenshots of regulatory ... · The CTD triangle. The Common Technical Document is organized into five modules. Module 1 is region specific and modules](https://reader031.vdocuments.mx/reader031/viewer/2022041914/5e68bc937196eb58f33c9a9d/html5/thumbnails/7.jpg)
Certificate of analysis (Source: Tamiflu (Oseltamivir) trial WP16263 PDF pp. 422-3)
Clinical Study Report (source: Tamiflu (Oseltamivir) trial M76001 PDF p.13)
![Page 9: Screenshots Gallery Selected screenshots of regulatory ... · The CTD triangle. The Common Technical Document is organized into five modules. Module 1 is region specific and modules](https://reader031.vdocuments.mx/reader031/viewer/2022041914/5e68bc937196eb58f33c9a9d/html5/thumbnails/9.jpg)
![Page 10: Screenshots Gallery Selected screenshots of regulatory ... · The CTD triangle. The Common Technical Document is organized into five modules. Module 1 is region specific and modules](https://reader031.vdocuments.mx/reader031/viewer/2022041914/5e68bc937196eb58f33c9a9d/html5/thumbnails/10.jpg)
Drug Approval Package (Source: FDA website)
Drug Label (Source)
![Page 11: Screenshots Gallery Selected screenshots of regulatory ... · The CTD triangle. The Common Technical Document is organized into five modules. Module 1 is region specific and modules](https://reader031.vdocuments.mx/reader031/viewer/2022041914/5e68bc937196eb58f33c9a9d/html5/thumbnails/11.jpg)
European Public Assessment Report (Source: website and document)
![Page 12: Screenshots Gallery Selected screenshots of regulatory ... · The CTD triangle. The Common Technical Document is organized into five modules. Module 1 is region specific and modules](https://reader031.vdocuments.mx/reader031/viewer/2022041914/5e68bc937196eb58f33c9a9d/html5/thumbnails/12.jpg)
![Page 13: Screenshots Gallery Selected screenshots of regulatory ... · The CTD triangle. The Common Technical Document is organized into five modules. Module 1 is region specific and modules](https://reader031.vdocuments.mx/reader031/viewer/2022041914/5e68bc937196eb58f33c9a9d/html5/thumbnails/13.jpg)
![Page 14: Screenshots Gallery Selected screenshots of regulatory ... · The CTD triangle. The Common Technical Document is organized into five modules. Module 1 is region specific and modules](https://reader031.vdocuments.mx/reader031/viewer/2022041914/5e68bc937196eb58f33c9a9d/html5/thumbnails/14.jpg)
Medical Officer Review (Source)
![Page 15: Screenshots Gallery Selected screenshots of regulatory ... · The CTD triangle. The Common Technical Document is organized into five modules. Module 1 is region specific and modules](https://reader031.vdocuments.mx/reader031/viewer/2022041914/5e68bc937196eb58f33c9a9d/html5/thumbnails/15.jpg)
![Page 16: Screenshots Gallery Selected screenshots of regulatory ... · The CTD triangle. The Common Technical Document is organized into five modules. Module 1 is region specific and modules](https://reader031.vdocuments.mx/reader031/viewer/2022041914/5e68bc937196eb58f33c9a9d/html5/thumbnails/16.jpg)
Patient Information Leaflet (Source)
![Page 17: Screenshots Gallery Selected screenshots of regulatory ... · The CTD triangle. The Common Technical Document is organized into five modules. Module 1 is region specific and modules](https://reader031.vdocuments.mx/reader031/viewer/2022041914/5e68bc937196eb58f33c9a9d/html5/thumbnails/17.jpg)
Statistical Officer Review (Source)
![Page 18: Screenshots Gallery Selected screenshots of regulatory ... · The CTD triangle. The Common Technical Document is organized into five modules. Module 1 is region specific and modules](https://reader031.vdocuments.mx/reader031/viewer/2022041914/5e68bc937196eb58f33c9a9d/html5/thumbnails/18.jpg)
Study Protocol (Source)
![Page 19: Screenshots Gallery Selected screenshots of regulatory ... · The CTD triangle. The Common Technical Document is organized into five modules. Module 1 is region specific and modules](https://reader031.vdocuments.mx/reader031/viewer/2022041914/5e68bc937196eb58f33c9a9d/html5/thumbnails/19.jpg)
![Page 20: Screenshots Gallery Selected screenshots of regulatory ... · The CTD triangle. The Common Technical Document is organized into five modules. Module 1 is region specific and modules](https://reader031.vdocuments.mx/reader031/viewer/2022041914/5e68bc937196eb58f33c9a9d/html5/thumbnails/20.jpg)
![Page 21: Screenshots Gallery Selected screenshots of regulatory ... · The CTD triangle. The Common Technical Document is organized into five modules. Module 1 is region specific and modules](https://reader031.vdocuments.mx/reader031/viewer/2022041914/5e68bc937196eb58f33c9a9d/html5/thumbnails/21.jpg)
Summary of Product Characteristics (Source)