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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
zhlédnutí: 27

Video

(Subbed for wb.) Creating a PMDA compliant PDF in under 60 seconds with DocShifter in 3 clicks
zhlédnutí 21Před 3 měsíci
(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
zhlédnutí 23Před 3 měsíci
(Subbed for wb.) Automatically bookmarking a PDF that contains no bookmarks in the source content
Subtitled - Automated incoming email to PDF conversion scenarios
zhlédnutí 33Před 3 měsíci
Subtitled - Automated incoming email to PDF conversion scenarios
Automatically identify issues in PDF files and fix them for compliance in Microsoft SharePoint with
zhlédnutí 22Před 4 měsíci
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
zhlédnutí 16Před 4 měsíci
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.
zhlédnutí 36Před 4 měsíci
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
zhlédnutí 17Před 4 měsíci
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
zhlédnutí 25Před 5 měsíci
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?
zhlédnutí 12Před 5 měsíci
"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.
zhlédnutí 38Před 7 měsíci
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
zhlédnutí 29Před 7 měsíci
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
zhlédnutí 91Před 10 měsíci
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)
zhlédnutí 118Před 11 měsíci
​​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?
zhlédnutí 105Před 11 měsíci
[Mini demo] Automated Report Generation with DocShifter - What are the benefits? How does it work?
[Mini Demo] Submission ready PDF generation
zhlédnutí 137Před 11 měsíci
[Mini Demo] Submission ready PDF generation
Computer Software Validation (CSV) vs Computer Software Assurance (CSA): What & How & Benefits
zhlédnutí 676Před rokem
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)
zhlédnutí 320Před rokem
How to render Veeva binders with DocShifter into submission-ready PDFs (& other content automation)
Report Generation Automation Webinar (with Reports+ Demo)
zhlédnutí 49Před rokem
Report Generation Automation Webinar (with Reports Demo)
eCTD Global Aspects and Future Directions (LinkedIn Live with LORENZ Life Sciences Group)
zhlédnutí 137Před rokem
eCTD Global Aspects and Future Directions (LinkedIn Live with LORENZ Life Sciences Group)
Benefits and the impact of DocShifter at PharmaLex
zhlédnutí 33Před rokem
Benefits and the impact of DocShifter at PharmaLex
What challenges did DocShifter solve at PharmaLex?
zhlédnutí 31Před rokem
What challenges did DocShifter solve at PharmaLex?
How does PharmaLex use DocShifter to streamline submission-ready PDF publishing for eCTD submissions
zhlédnutí 22Před rokem
How does PharmaLex use DocShifter to streamline submission-ready PDF publishing for eCTD submissions
Automate submission content prep. & report generation in Veeva with DocShifter
zhlédnutí 176Před rokem
Automate submission content prep. & report generation in Veeva with DocShifter
How to automate SharePoint document preparation & report generation using DocShifter
zhlédnutí 96Před rokem
How to automate SharePoint document preparation & report generation using DocShifter
[Recording] How to automate submission content prep. & report generation for content stored in Veeva
zhlédnutí 214Před rokem
[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
zhlédnutí 28Před rokem
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)
zhlédnutí 98Před rokem
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 )
zhlédnutí 1,2KPřed rokem
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
zhlédnutí 62Před 2 lety
How to accelerate content preparation for regulatory submissions? A case study by PharmaLex

Komentáře

  • @sandeepsinghrajpoot1616
    @sandeepsinghrajpoot1616 Před 3 měsíci

    Very well explaine❤😊

  • @varshareddy-we3dv
    @varshareddy-we3dv Před 10 měsíci

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

  • @docshifter
    @docshifter Před rokem

    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 Před rokem

    Very informative webinar.. Thank you!

  • @isaactaylor2601
    @isaactaylor2601 Před rokem

    🤭 *Promosm*

  • @mrmrsrockz6592
    @mrmrsrockz6592 Před rokem

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

  • @kaialcelestyna3771
    @kaialcelestyna3771 Před 3 lety

    gi570 vun.fyi

  • @fayezsa
    @fayezsa Před 7 lety

    Hi can i know who did the video for you ?

    • @docshifter
      @docshifter Před 7 lety

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