Look for me at the DIA Annual Meeting /eCTD Related Presentations

The DIA Annual Meeting will be held in San Diego June 20-25.  If you are attending and we haven’t met yet, I’d love to meet you!  Look for me in our booth, 923 (get your badge scanned to enter a drawing for our extremely cool giveaway – I’m not going to reveal what it is).  I’ll be joined in the booth by my collegues and well-known industry experts Jason Rock and Rahul Mistry.

I’ll also be in some of the eCTD-related sessions, which include:

  • International eCTDs: An Update on Regulatory Authority Experience
  • Authoring CTD/eCTD Submissions: Updates and Case Studies
  • FDA Data Standards Initiatives (Featuring GlobalSubmit’s CTO, Jason Rock)
  • Convergence of Data and Document Standards: Where Does CDISC Meet eCTD?
  • Pursuing Standards to Enhance eCTD Deliverables: Pharmaceutical and Research Manufacturer Association Electronic Regulatory Submissions (PhRMA ERS) Group Annual Update
  • Global Submission Management: Challenges and Opportunities
  • Standards Shock Therapy: Monitoring the State of CDISC and HL7 for Clinical Research and Regulatory Submissions (Featuring GlobalSubmit’s CTO, Jason Rock)
  • IND to CTD in Electronic Format: Strategic Considerations for Life-cycle Maintenance
  • Annual CDER eSubmission Update: The Technical Side
  • Life-cycle Management: Where the Real Challenges Are – Module 3, IND and NDA
  • International eCTDs: An Update on Regulatory Authority Experience
  • Authoring CTD/eCTD Submissions: Updates and Case Studies

 

I’ll be commenting on the presentations on this blog in late June or early July.

Article written by

I am GlobalSubmit’s director of professional services. My area of expertise is electronic document management and regulatory submissions, specifically eCTD. I have 12 years of biopharmaceutical industry experience in the US, Europe, Israel and Japan, concentrating on content management for Regulatory Affairs & Submissions, Clinical Development, and Manufacturing, and in submission assembly and publishing. I have worked with over 50 pharmaceutical clients. Previously, I was the practice lead for the Subject Matter Experts/Business Analysts group at First Consulting Group (FCG), now part of CSC. I supervised a group of 12 SMEs/BAs. I was instrumental in the development of the FirstDoc® suite. I developed the project delivery methodology for FirstDoc® R&D, including training materials, project plans, workshop methodology and materials, and requirements and design specifications. I managed the design and development of FirstDoc® GMP and FirstDoc® Legal. Please feel free to contact me at kathleen.clark@globalsubmit.com if you are interested in talking about eCTD products or consulting services, or if you have ideas for the blog.

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