GlobalSubmit Presents eCTD Essentials in Multiple Cities this October

In recent years eCTD has become the preferred format for regulatory submissions worldwide, and momentum continues to build as mandates take effect in Europe and the United States. Compiling an electronic regulatory submission is a challenging task even for industry veterans who’e worked on multiple projects. Naturally, an organization making the transition from paper to electronic format or compiling a submission for the first...

Read More

ICH, HL7 to Jointly Develop Next Major Version of eCTD

The ICH M2 ESTRI Main Page has been updated with the following announcement: “ICH M2 has initiated the development of the Next Major Version of the eCTD (eCTD NMV) to improve robustness, flexibility and long term stability of the message. In accordance with the decision by the ICH Steering Committee that technical specifications should no longer be developed solely within ICH, but should be created in collaboration with Standards...

Read More

Final Health Canada eCTD Guidance Addresses Naming Conventions, Lifecycle Operations

Health Canada has posted a final version of Guidance for Industry: Preparation of Drug Submissions in Electronic Common Technical Document (eCTD) Format on their web site. This version, dated November 4, 2009, replaces the draft version dated January 25, 2006. On the whole, the changes are more evolutionary than revolutionary. Throughout the document, the previous terminology of “Annual update forms summarizing the Notices of Change”...

Read More

GlobalSubmit Exhibiting at DIA Annual Meeting in San Diego

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...

Read More