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Evolution of the Regulatory Operations Organisation — Recording from the 31.07 live session
An exciting discussion with lots of insights is still our promise, and we look forward to welcoming you, and all your questions.
- How is the Regulatory Operations organisation evolving in the near and longer term?
- How are the roles and remits in Regulatory Operations evolving?
- Is this different between smaller and larger organisations?
00:00 - Intro
02:47 - Q1: How is RegOps evolving?
7:16 - Q2: How are the roles in RegOps evolving?
19:44 - Q3: How about automation & AI?
29:04 - Q4: How about the role of a publisher?
30:43 - Q5: Driving decisions from regulatory intelligence
33:18 - Closing remarks
มุมมอง: 27

วีดีโอ

(Subbed for wb.) Creating a PMDA compliant PDF in under 60 seconds with DocShifter in 3 clicks
มุมมอง 213 หลายเดือนก่อน
(Subbed for wb.) Creating a PMDA compliant PDF in under 60 seconds with DocShifter in 3 clicks
(Subbed for wb.) Automatically bookmarking a PDF that contains no bookmarks in the source content
มุมมอง 233 หลายเดือนก่อน
(Subbed for wb.) Automatically bookmarking a PDF that contains no bookmarks in the source content
Subtitled - Automated incoming email to PDF conversion scenarios
มุมมอง 333 หลายเดือนก่อน
Subtitled - Automated incoming email to PDF conversion scenarios
Automatically identify issues in PDF files and fix them for compliance in Microsoft SharePoint with
มุมมอง 224 หลายเดือนก่อน
Quality Checks for PDF compliance Automatically ensure all PDFs included in a regulatory submission are technically compliant. Check and fix issues including: Bookmarks; PDF properties & security issues; Page; Hyperlinks; Font and initial view; Annotation and text issues and many more. For more information, please visit: www.docshifter.com/use-cases/docshifter-sharepoint-automation/
Genearate submission ready PDFs directly from your content in Microsoft SharePoint
มุมมอง 164 หลายเดือนก่อน
Compliant PDFs from your documents in SharePoint Take your Word, PowerPoint, Excel files, images, XML, HTML, and other file types in Microsoft SharePoint, and create FDA, PMDA, EMA compliant renditions from 1 source document. For more information, please visit: www.docshifter.com/use-cases/docshifter-sharepoint-automation/
Automated report generation from Microsoft SharePoint: Merge documents into compliant PDF reports.
มุมมอง 364 หลายเดือนก่อน
Merge Multiple Documents & Zip Files into compliant PDF reports Simply define what content you want to go into the report. DocShifter will monitor the folders in your SharePoint environment, and automate the creation of your report by merging documents together based on the triggers you define. For more information, please visit: www.docshifter.com/use-cases/docshifter-sharepoint-automation/
Automated Word content preparation in Microsoft SharePoint with DocShifter
มุมมอง 174 หลายเดือนก่อน
Fix Styling & Formatting Errors in Word & PDF documents to ensure compliance. Automated checks for your Word documents in Microsoft SharePoint. Check for issues with: Paragraph; Tables; Linking; Images; Styles and Headings. Increase efficiency in your document quality control and reduce risk of non-compliance. For more information, visit: www.docshifter.com/use-cases/docshifter-sharepoint-autom...
Report Generation with 3 click Document Compliance
มุมมอง 255 หลายเดือนก่อน
How to go from a basic ZIP File that contains individual Microsoft Word documents to a fully compliant PDF report, with the right bookmarks, hyperlinks, cover page, table of content, page numbers? Enter 3 click document compliance from DocShifter. 1. Select your ZIP file that contains your individual documents 2. Upload to DocShifter Express 3. Get your result back. The PDF output can also be m...
Move PDF compliance earlier in the Regulatory Submission Process - What does it even mean?
มุมมอง 125 หลายเดือนก่อน
"If you want to accelerate your submission process, achieve document compliance earlier in your submission process." If you ever attended one of our webinars, you will have heard us say this a lot. But, what do we actually mean by 'achieve document compliance earlier'? A typical drug development process takes from 5 and 15 years, and documentation is created every step of the way. Submissions a...
3 click method: Creating a PMDA compliant PDF in under 60 seconds with DocShifter Express.
มุมมอง 387 หลายเดือนก่อน
3 click method: Creating a PMDA compliant PDF in under 60 seconds with DocShifter Express.
Automatically bookmarking a PDF that contains no bookmarks in the source content with DSExpress
มุมมอง 297 หลายเดือนก่อน
How can you automatically create bookmarks in a PDF, even when the source document contains no bookmarks? Discover how #DocShifter can automate this.
Achieving Regulatory Excellence: Must-Have Attributes - with Dr. von Glahn
มุมมอง 9110 หลายเดือนก่อน
What makes a global regulatory organization effective? What are the musts to have? What are certain features to have defined in your organization to become an efficient global regulatory organization? In this thought leadership session, we are welcoming Dr. Benita von Glahn (Head Global Regulatory Affairs and member of the R&D Executive Leadership Team) from Merz Therapeutics. Dr. von Glahn wil...
Automating Submission Document Preparation in OpenText Documentum With DocShifter (+ practical demo)
มุมมอง 11811 หลายเดือนก่อน
​​Are you looking for ways to further automate and simplify the way you prepare content for submissions in OpenText Documentum? ​​​Combining the power of DocShifter with OpenText Documentum, you can take submission content preparation to the next level. ​The automation allows you to focus on what matters most: the content. - ​​​How will this powerful combination help you save time with the foll...
[Mini demo] Automated Report Generation with DocShifter - What are the benefits? How does it work?
มุมมอง 10511 หลายเดือนก่อน
[Mini demo] Automated Report Generation with DocShifter - What are the benefits? How does it work?
[Mini Demo] Submission ready PDF generation
มุมมอง 13711 หลายเดือนก่อน
[Mini Demo] Submission ready PDF generation
Computer Software Validation (CSV) vs Computer Software Assurance (CSA): What & How & Benefits
มุมมอง 676ปีที่แล้ว
Computer Software Validation (CSV) vs Computer Software Assurance (CSA): What & How & Benefits
How to render Veeva binders with DocShifter into submission-ready PDFs (& other content automation)
มุมมอง 320ปีที่แล้ว
How to render Veeva binders with DocShifter into submission-ready PDFs (& other content automation)
Report Generation Automation Webinar (with Reports+ Demo)
มุมมอง 49ปีที่แล้ว
Report Generation Automation Webinar (with Reports Demo)
eCTD Global Aspects and Future Directions (LinkedIn Live with LORENZ Life Sciences Group)
มุมมอง 137ปีที่แล้ว
eCTD Global Aspects and Future Directions (LinkedIn Live with LORENZ Life Sciences Group)
Benefits and the impact of DocShifter at PharmaLex
มุมมอง 33ปีที่แล้ว
Benefits and the impact of DocShifter at PharmaLex
What challenges did DocShifter solve at PharmaLex?
มุมมอง 31ปีที่แล้ว
What challenges did DocShifter solve at PharmaLex?
How does PharmaLex use DocShifter to streamline submission-ready PDF publishing for eCTD submissions
มุมมอง 22ปีที่แล้ว
How does PharmaLex use DocShifter to streamline submission-ready PDF publishing for eCTD submissions
Automate submission content prep. & report generation in Veeva with DocShifter
มุมมอง 176ปีที่แล้ว
Automate submission content prep. & report generation in Veeva with DocShifter
How to automate SharePoint document preparation & report generation using DocShifter
มุมมอง 96ปีที่แล้ว
How to automate SharePoint document preparation & report generation using DocShifter
[Recording] How to automate submission content prep. & report generation for content stored in Veeva
มุมมอง 214ปีที่แล้ว
[Recording] How to automate submission content prep. & report generation for content stored in Veeva
The Economics of Technology Innovation in Regulatory Live with John Cogan
มุมมอง 28ปีที่แล้ว
The Economics of Technology Innovation in Regulatory Live with John Cogan
The Evolving State of Global Dossier Management (featuring Steve Gens, Preeya Beczek & Paul Ireland)
มุมมอง 98ปีที่แล้ว
The Evolving State of Global Dossier Management (featuring Steve Gens, Preeya Beczek & Paul Ireland)
eCTD 4.0: What is Changing (with Paul Ireland - VP Life Sciences @docshifter )
มุมมอง 1.2Kปีที่แล้ว
eCTD 4.0: What is Changing (with Paul Ireland - VP Life Sciences @docshifter )
How to accelerate content preparation for regulatory submissions? A case study by PharmaLex
มุมมอง 622 ปีที่แล้ว
How to accelerate content preparation for regulatory submissions? A case study by PharmaLex

ความคิดเห็น

  • @sandeepsinghrajpoot1616
    @sandeepsinghrajpoot1616 3 หลายเดือนก่อน

    Very well explaine❤😊

  • @varshareddy-we3dv
    @varshareddy-we3dv 10 หลายเดือนก่อน

    Hi sir.... Will you provide individual training on docshifter for who wants to pursue a career in regulatory affairs..??????

  • @docshifter
    @docshifter ปีที่แล้ว

    For any questions from the webinar, please let us know here in the comments section! We look forward to seeing you in our future webinars!

  • @AlpTetikel
    @AlpTetikel ปีที่แล้ว

    Very informative webinar.. Thank you!

    • @docshifter
      @docshifter 10 หลายเดือนก่อน

      Glad it was helpful!

  • @isaactaylor2601
    @isaactaylor2601 ปีที่แล้ว

    🤭 *Promosm*

  • @mrmrsrockz6592
    @mrmrsrockz6592 ปีที่แล้ว

    Very insightful talk!! Thanks Docshifter for getting Akira Talk!!

    • @docshifter
      @docshifter ปีที่แล้ว

      Glad you enjoyed it!

  • @kaialcelestyna3771
    @kaialcelestyna3771 3 ปีที่แล้ว

    gi570 vun.fyi

  • @fayezsa
    @fayezsa 7 ปีที่แล้ว

    Hi can i know who did the video for you ?

    • @docshifter
      @docshifter 7 ปีที่แล้ว

      Hi, we had the pleasure to work with www.storyme.com :-)