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How to automate PDF rendering for global submissions with DocShifter (with a practical demo)

Hosted by Paul Ireland - VP Life Sciences
 
 
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About Event
  • The process of preparing content for submissions is very time-consuming and financially burdensome

  • Using multiple desktop tools, and spending hours or even days, manually editing PDFs to meet the FDA, EMA, PMDA, etc. requirements 

  • Manually checking and fixing thousands of PDF files for submission readiness

  • Re-working external content to ensure document compliance

  • Validating content too late, and the risk of missing submission deadlines

  • Authors are sharing documents at the very last-minute

Are you facing these issues in your document preparation for submissions?

Today, this process does not have to be this complex and difficult for CROs, pharmaceutical and biotechnology companies. 

Join us in this webinar (25 minutes) + practical demo (15 minutes), and see how you can reduce manual work and risks and introduce automation to help accelerate time to market. We will talk about saving time, and avoiding common pitfalls when preparing PDF documents for submissions.

Discover how you can easily:

  • Make sure that the PDFs created are fully compliant with the Health Authority specifications. Fully automated, without any user intervention.

  • Reduce the dependency on manual PDF editing tools to create compliant PDFs.

  • Speed-up time to market by moving technical content compliance earlier in your regulatory content creation process

  • Save valuable time and drastically reduce risk of non-compliance

Paul Ireland will also walk you through a 15 minute practical demonstration on how all this can be achieved. Fully automated.

We look forward to seeing you in our webinar on June 8, Thursday!

Learning Objectives

​See how you can easily leverage automation to reduce manual work when creating eCTD compliant PDFs.

This webinar will also give you the opportunity to understand how

  • ​DocShifter helps biotechnology, pharmaceutical and CRO companies significantly accelerate time to market

  • ​Technical document compliance in your submissions can be achieved earlier; reducing risks of non-compliance

​We look forward to seeing you in our webinar!

​Who should attend?

  • ​Regulatory Affairs and Operations

  • ​Regulatory Information Management

  • ​Submissions and Global Submissions

  • ​Management/Project Management

  • ​Medical, Technical, and Regulatory Writers

  • ​Clinical Data/Data Managers

  • ​Information Technology and Support Personnel

  • ​Document and Records Management/Specialists

  • ​Essential Document Process and Business System Owners

  • ​Regulatory Standards Implementation Specialists and Associates

  • ​Clinical Operations and Processes

  • ​Quality Management

  • ​Quality Assurance/Quality Control and Compliance Professionals

  • ​Strategic Planning and Operations

  • ​Contract Research and Service Support Providers

  • ​Emerging Pharmaceutical/Biotech/Device Professionals