eCTD on Twitter
- Malta: Requirements on Electronic submissions for New Applications within National and European procedures #ectd
http://bit.ly/9m1pQl2010/09/08 09:39 - Check out Reed Tech's LabelDataPlus super search tool for SPL, searching repository of of 27052 drug labels:
http://bit.ly/cYdc982010/09/07 12:03 - Highlights of IRISS Interoperability group’s July, August mtgs posted, incl some FDA news
http://bit.ly/bPEeEN & http://bit.ly/brD5OY #ectd2010/08/31 10:07
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Archive for March, 2010
A Compendium of Recent eCTD and eSubmissions News (Part 1)
posted by Kathie Clark @ 2:03 AM
Thursday, March 25, 2010
Some people who read this blog may be aware that I also post eCTD-related updates on my twitter account (www.twitter.com/kathie_clark). I use this medium to post agency news updates, information I hear from the regulators, and interesting articles or presentations that I come across. For more significant news, I usually follow up with a blog posting.
Recently, several people who read the blog have told me that, due to company restrictions, they are not able to follow twitter updates. In addition, there are certainly people who just don’t like twitter (and I can sympathize as there is certainly a lot more trivia and minutia than useful content on most twitter postings). These colleagues have suggested that I periodically summarize the more interesting information I post on twitter on a blog posting as well. Today, I’m taking them up on that suggestion. For part 1, here is a variety of news I posted on Twitter since February 1, 2010, related to interesting white papers, webinars, presentations, blog postings, and online articles. Next post will feature agency news, documents and presentations.
Interesting White Papers, Webinars and Presentations
- GlobalSubmit has several free white papers available to sponsors – request by emailing marketing@globalsubmit.com:
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Ensuring eCTD Quality: Points to Consider for Regulatory Affairs Professionals
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5 Key Recommendations for Improving eCTD Module 3 Quality & Reviewability
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What Makes an eCTD Clinical Study Easily Reviewed by the FDA?
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GlobalSubmit is also presenting an encore of our free webinar Get up to date on the Regulated Product Submission standard on April 1st at 1 PM EST.
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Download the podcast “How to Prepare Your Product Dossier for Global Simultaneous eCTD/CTD Submissions – A Look at Tools, Tips and Taking the Mystery Out of Submission Planning and Publishing” by Meredith Sewell, Associate Director, Global Regulatory Affairs Publishing, Allergan, Inc. Meredith is an excellent speaker and an eCTD veteran with many practical suggestions.
Online Articles and Blog Postings
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To learn more about how the different agencies group eCTD sequences into regulatory activities for review, read Secrets of eCTD Related Sequences at Applied Clinical Trials Online.
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Antoinette Azevedo, President & CEO, e-SubmissionSolutions.com, contributed Speeding Time To Market For Pharmaceutical & Biotechnology Companies on GxP Lifeline. This article looks at taking advantage of the eCTD format – and consequences of not doing so.
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A blog posting on Monte Leveson’s “Aerie Canal” blog provides sound advice on Final Submission QC, and even includes a sample QC sheet in MS Word format that you can modify for your own use: Final QC Sheet. ForeignExchange Translations blog further commented on Final QC of electronic submissions.
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Dr Martin Moxham of iRegulatory commented on the potential of PIM to make the lives of regulatory professionals easier, and concluded “a switch to managing product information in structured format (such as PIM) has clear benefits in terms of decreased resource requirements, decreased cost, enhanced quality and ease of management of translation.”
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GxP Lifeline featured an article by Cato’s Rachel Cooper - Strategies for eCTD Marketing Application Submissions. This article talks about project management tools such as the integrated Table of Contents (spreadsheet) and rolling submission management.
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The Medical Translation Insight blog posted Bulgaria catches up with e-submissions, which talks about the progress that this agency has made in completing readiness preparations in the last several yearz.
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The eCTD Upgrade: Cross-Application Linking on the PharmTech web site provides some tips on cutting time and cost by re-using already submitted documents. As a quick reminder, this applies to US submissions only as cross application linking is not accepted by EMEA.
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The BayBio blog posted a good basic overview: eCTD Submission Specifications.
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The Dante Resource Group Blog contributed Preparing a CTD, eCTD Project Planner for your clinical submission.
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GlobalSign provided a useful list of Frequently asked questions when using a GlobalSign Digital ID to submit documents to the FDA eSubs Gateway ESG.
So, to wrap up: if you have made it this far and found “news you can use” in this article, you may want to consider following me on Twitter so you get a more timely update. If you have a twitter account, this is easy to do, but even if you don’t, you can just go to the web page www.twitter.com/kathie_clark for the latest updates (and the last three tweets always appear on the upper left column of this blog). You may also want to follow my company, GlobalSubmit, at www.twitter.com/globalsubmit. You don’t actually need a twitter account to do this.
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eCTD for INDs: How Do Sponsors Perceive the Value Proposition?
posted by Kathie Clark @ 9:00 AM
Wednesday, March 17, 2010
On March 10th, I attended the eCTD 2010 conference in Philadelphia. The conference attendees included a number of smart and experienced eCTD professionals. During a round-table session, I asked the group if they were submitting INDs in eCTD format, and if so, why they felt there was value in doing so. I asked this question because at this date only 12% of INDs are submitted in eCTD format, and I’m curious as to why the number isn’t higher.
The answers surprised me a little. Almost everyone in the group exclusive of CROs (obviously captive to the wishes of their sponsors) had converted all active INDs to eCTD format. (It should be noted that all the respondents have marketed products at this point.) Their rational in doing so included:
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Aversion to maintaining the overhead of two processes (one paper and one electronic) as they felt it would be confusing to their authors and publishers. Training on a single process is a big plus.
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Development of a healthy aversion to paper, or “tree killing” as they put it.
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Identification of eIND as an important training ground for their authors and publishers, giving them both experience and confidence for producing eCTD NDAs.
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Potential for re-using documents such as M4 nonclinical study reports in an NDA (although most companies reported that they were re-submitting content in this case, not pointing to IND content – see my previous post Cross Application Links in eCTD for a discussion).
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Increased attractiveness of an eCTD formatted product to a potential buyer (although they be acknowledged that this would not always be identified by the buyer.
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Highly increased ability to communicate with the FDA when questions are raised. Information is on the user’s desktop instead of a remote archive.
Overall, support for eCTD IND was very strong in this group.
So why are so many INDs still in paper? The consensus was that for companies with only one product, investigator INDS, etc. the investment, even if modest, was probably not justified. However, the group felt that companies with marketed products submitting NDAs in eCTD format should strongly consider creating or switching their INDs as well.
On March 10th, I attended the eCTD 2010 conference in Philadelphia. The conference speakers included a number of experienced directors and senior directors of regulatory affairs/reg operations from medium and large Pharma companies. During a panel discussion, an excellent question was posed: what are your biggest challenges – what keeps you up at night?
Although we received four different answers from the panelists, they all had a common theme: the impact of globalization and resource constraints on their ability to be successful.
The first panelist worried about how to staff and budget for global expansion (beyond US/EU/CA/JP). He identified the myriad of local format requirements and the need to work with local regulatory groups and consultants as concerns. He emphasized the need to think out plans and procedures before acting.
The second panelist also cited globalization, which for his company increased the need to work with partners and vendors, adding complexity and complications to existing processes. He found that globalization is changing his company’s regulatory strategy and increased the need to identify and comply with standards.
The third director mentioned that technical issues such as Regulated Product Submissions did not concern her. Instead, she identified the impact of the poor economy, which results in both resource constraints and requests for greater speed. She finds her group to be very resource constrained, and is concerned that if she adds temporary help, she may not be able to train them quickly enough for them to take on major responsibilities.
Finally, the fourth director noted that lack of alignment between business and IT was creating a major risk. For example, the business is placing a high priority on expansion into additional countries and regions – but IT does not have the necessary software upgrades in their work plan. Due to resource and funding constraints, IT is being driven to minimize upgrades while the business wants new features that will increase their efficiency due to their reduced or frozen headcount. He sees more and more a discrepancy between what the business needs and what it is possible for IT to do.
I’m grateful for the willingness of the panelists to share their thoughts and concerns, which was very useful to me in understanding the current business climate. I would be interested in your thoughts about this topic, which results in challenges for most of us connected with this business in any capacity.