Collection of eCTD Online News, Part 2
A number of good articles related to eSubmissions have been posted online recently. Below, a recap based on posts from my twitter account, www.twitter.com/kathie_clark.
- Even Richardson of Cato Research posted a useful blog entry, Bookmarks – Collapsed or Expanded? On the “Ask Cato” blog. The entry discusses the FDA reviewers’ preferences for the default expansion of PDF bookmarks.
- Pharma IQ shared the results of their recent poll, “Do Electronic Submissions Save Pharmaceutical Companies Time? The majority of respondents said yes (62.1%) but there was still a fair amount of people that thought it didn’t change the time spent on submissions and some stating it actually takes them longer.
- There’s a really nice online training resource with slide/lecture format covering: labeling, regulatory strategy, new drug applications, and the FDA approval process. Can’t quite figure out who is behind this, as there is no home/about page!
- Ed Tripp has published a good article, Meeting Agency eCTD Expectations for Efficient Navigation, that discusses standards and processes for producing reviewable documents.
- Our own GlobalSubmit Suite 2010 Beta Test Program (eCTD publishing, validation, and review) was discussed the “Ask Cato” blog.
- In Saving Time by Meeting CDISC Standards: PharmaIQ talks with CDISC.
- Were you aware that the FDA won a Bio-IT World best practice award? Jason Rock of GlobalSubmit talks about the award received for use of the REVIEW eCTD Viewer by FDA, eCTD adoption at Bio-IT World.
- In the podcast A Regulatory Perspective: Integrating PIM into the Product Lifecycle: Helen Winsor from Pharma IQ speaks to Dr. Andrew Marr about the latest developments in Project Information Management (PIM) and why it is important to prepare before implementing PIM. Dr. Marr also outlines the main challenges faced and the lessons learned so far by trial groups – and talks in depth about the advantages to be gained from implementation.
- Our friends at Medical Translation Insight ponder When will e-labeling become reality for devices?
- Europharm-smc position paper on eCTD implementation in Europe http://bit.ly/djms4y
- For those new to eSubmissions, What is eSubmission, eCTD provides some basics on the UKoom blog.
- Pharma IQ reports that eCTD Rises in Popularity Across Europe.
In Standards news:
- There’s a new Regulated Product Submission (RPS) DSTU Technical Q&A wiki page
- There’s a new list of controlled vocabulary for RPS R2 DSTU, discussed on the Exalon website.
- In CDISC news, see ADaM Validation Checks Call for Public Review.
Finally, a few upcoming conferences have been announced:
- For those lucky people living in or able to travel to Australia, there’s the Introduction to the electronic Common Technical Document (eCTD) Conference on 13 – 14 September in Canberra.
- eCTD Submissions in Switzerland, organized by DIA Europe, will be presented in Zurich on December 9, 2010.
- The Polish agency will discuss eCTD along with other topics during Registration of Drugs – 13-14 September in Warsaw.
- The DIA US and International Prescription Drug Labeling preconference workshop December 7 in Washington, DC focuses on PIM and SPL.