Held in beautiful, Indianapolis, IN, the theme of the Documentation & Training Life Sciences 2008 Conference is The Right Prescription For Life Sciences Content. The event takes place June 23-26, 2008.
For $1,299 you get all of the following:
- Choice of pre-conference half-day workshops (June 23)
- Choice of over 30 conference sessions (June 24-25)
- Choice of post-conference half-day workshop (June 26)
- Access to the networking cocktail reception (June 24)
- Breakfast and carving station lunches during conference
Antoinette Azevedo Provides Practical Guidance For Preparing Compliant eCTD Submissions
Life sciences regulatory authorities in North America, Europe and Japan have been developing standards for drug and biologic registration submissions in electronic format for over ten years. The current version of the format—electronic Common Technical Document (eCTD)—has been the recommended format since 2005 and is on the way to becoming mandatory. At Documentation and Training Life Sciences, Antoinette Azevedo, president of e-SubmissionsSolutions.com, will open the pharmaceutical track with a presentation entitled Preparing Compliant eCTD Submissions. The session will provide attendees with an overview of best practices that will enable a sponsor to prepare a compliant eCTD for regulatory authority review. Here’s a sneak peek at why this topic is so important.
A California biotech submitted an eCTD to the US FDA in summer 2005. This company used commercial-off-the-shelf publishing software, experienced consultants, and in-house staff to compile this eCTD. This drug was the biotechs first candidate for commercialization. The biotech was partnered with big Pharma to assist with sales and marketing after the FDA authorized the drug for marketing. The biotech hired a sales force of nearly 200 in anticipation of FDA approval.
The FDA issued a refuse-to-file on this eCTD in fall 2005, due to problems with the PDF files and navigability of the content of the submission. The company’s market capitalization dropped 50% overnight. The company had to recompile the submission, by reworking the source files and rebuilding the XML backbone. The new version of the eCTD was resubmitted in early 2006. The FDA accepted the resubmission for review.
However, in May 2006 the FDA issued an approvable letter, that meant the drug could be approved in the future if certain conditions were met (meaning yet another delay in being…
Presentation: Preparing Compliant eCTD Submissions
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