The eCTD summit

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.