Regulatory Publishing on the West Coast
On November 18, 2010, Canadian regulatory affairs professionals – members of RAPS Southern BC – will gather in Vancouver to network and share knowledge about regulatory publishing. Adlib will participate in this event by hosting a session about regulatory publishing.
The symposium is being sponsored by LORENZ Life Sciences, a global leader in electronic submissions and one of Adlib’s life sciences partners.
I will be hosting a workshop on Thursday, November 18 titled “Populating Your eCTD – Submission Document Rendering.” Topics will include:
- How the success of your eCTD submission depends on regulatory publishing compliance with the eCTD guidelines
- How to reduce document QA times, cut costs, speed up submission preparation, and reduce the potential for rejection due to formatting errors – by delivering flawlessly formatted PDFs that meet regulatory standards
- How some of the largest global pharmaceutical companies centralize and manage their document rendering process to reduce time-to-market and improve profitability
Canada lags behind the United States FDA and EMEA in adopting the eCTD (electronic Common Technical Document) format for electronic regulatory submissions. With these major markets mandating the use of this format, it shouldn’t be long until Canada takes the same position. Health Canada recently announced an increase in the scope of submission being accepted in eCTD format, and that they are accepting eCTD submissions in an electron-only filing format for some eCTD submissions.
The use of the eCTD format has several advantages over paper submissions. In the Health Canada eCTD pilot project, they observed the following benefits:
- Facilitated access to submissions
- Enhanced navigation through submissions via table of contents, bookmarks and hyperlinks
- Faster search/retrieval of information
- The ability to insert highlights and annotations directly in the submission without altering the original document
- The ability to share comments between evaluators in real-time
- The ability to copy information from the submission and paste it into review reports
Join us, to give your input and learn more about getting involved… at the very least, you’ll go home with some interesting perspectives and new information about the eCTD.