Short Introduction on the authority tool EURS is Yours

Transcription

1 Short Introduction on the authority tool EURS is Yours EURS is Yours as reviewing tool at MCC Michael Gessert Product Manager Global Review & Validation Dr. Gerhard Neurauter Director Regulatory Competence Center 14/15. February 2013

2 Agenda The Process overview Feature Overview Selected Features Import, validation, review process, annotations, import follow up Communication Applicant to Agency to Applicant, regarding validation and follow up steps EXTEDO Confidential 2

3 The Process overview EXTEDO Confidential 3

4 EURS is Yours as reviewing tool at MCC Validation Part I Compliance Check Import options EURS is Yours: Import single ectd Import single NeeS / vnees Batch Import of an existing Dossier (ectd) Inkremental batch Import into an existing Dossier (ectd) Batch Import with automatic Dossier creation (ectd) Validation Part II + III Technical Validation (part II) Completeness Check (according screening template) (part III) Content / business Validation (part III) EXTEDO Confidential 4

5 Electronic Review Lifecycle Management The electronic review cycle Level 1 Level 2 Level 3 Level 4 Check Dossier/ Submission Compare Submission Collect, Search and Read Documents Review Documents Level 5 Level 6 Level 7 Add Comments Annotations Receive External Assistance Report Creation EXTEDO Confidential 5

6 Feature Overview EXTEDO Confidential 6

7 EURS is Yours as reviewing tool at MCC - Basics Menu bar Tool bars Project Explorer Document Viewer Submission/ Document Explorer Review Tool Tabs Status bar EXTEDO Confidential 7

8 EURS is Yours Toolbars EXTEDO Confidential 8

9 Selected Features EXTEDO Confidential 9

10 Selected Features for the review process Identify the right dossier Searching/ Finding Navigation Submission comparing Viewing Filter (Delta View, Sequence View, Count View, FullView) Document Viewing Skimming, Favorites Explorer Document Preparing Highlights, Hyperlinks Document Reviewing PDF compare Document Annotation (Document safety!) PDF Annotation, TOC Annotation External Assistance External Shortcuts to Submission Documents or Modules in EURS is Yours Creating Assessment Report Scratchbook EXTEDO Confidential 10

11 Selected Features for the review process Sorting by Dossier name EURS is Yours Main View Dossier Groups Sorting by Reg Activities Working with small and handy groups of dossiers Other Sequences EXTEDO Confidential 11

12 Selected Features for the review process EURS is Yours Power Search Search Area / Filter Other Search options. Incl. Fulltext search an all documents EXTEDO Confidential 12

13 Selected Features for the review process EURS is Yours Easy Navigation Submission Envelope Document Empty Chapter Module Submission Explorer: An individual submission is displayed in the Submission Explorer. A submission contains of chapters, subchapters, documents and envelope elements EXTEDO Confidential 13

14 Selected Features for the review process EURS is Yours Color Codes Section Extensible Section Documents Empty Section Added documents are displayed in BLUE color EXTEDO Confidential 14

15 Authority Reviewing solution Current or Cumulative View EURS is Yours Views Displays documents according to their life cycle state (all filters are disabled: Standard View) Sequence View Standard View + Seq.-View Displays the sequence number as additional information Delta View Standard View + -View Displays newly added documents compared to previous submission Activity View Regulatory Activity Cumulates submissions of a single regulatory activity Count View Indicates the number of documents contained in the underlying sections EXTEDO Confidential 15

16 Authority Reviewing solution EURS is Yours Viewing Full flexibility in arranging your screen (s) EXTEDO Confidential 16

17 Authority Reviewing solution EURS is Yours external Experts Function Use case Data safety Drag & Drop document Export documents Offline Mode External Shortcut Create a local copy of a single document Create a document structure, similar to submission structure, optional: navigation xml file Create an Offline Project in EURS to work independently from your server database, syncronization on re-connect Allows to send other EURS users a hyperlink to EURS elements none, document is exported Full, documents are stored in EURS CITRIX Support of CITRX environment for remote use Full control EXTEDO Confidential 17

18 Compilation of MCC Module 1 Live demonstration! EXTEDO Confidential 18

19 Communication between Applicant & Agency EXTEDO Confidential 19

20 Communication between Applicant & Agency ectd provides only a defined way of communication from Applicant to Agency ectd communication specification is not bi-directional Official Communication from Applicant to Agency: ALWAYS providing a (new) sequence (according the MCC/ICH) Official Communication from Agency to Applicant: open standard communication (mail/ / telephone) More details in the official MCC documentation EXTEDO Confidential 20

21 Danke Baie Dankie Ngiyathokoza Ke a leboha Ke a leboga Siyabonga Inkomu Ndo livhuwa Ro livhuwa Enkosi Ngiyabonga Thank You