Japan and eCTD: What We Know
Mar29

Japan and eCTD: What We Know

Japan’s Pharmaceutical and Medical Devices Agency (PMDA), one of the earliest adopters of eCTD, adheres to a number of unique business rules which create a unique implementation of the eCTD specifications. Information available on eCTD best practices is also limited for this region, primarily due to lower levels of submission activity. What do we already know about submitting eCTDs in Japan and what can we expect later this decade as they implement eCTD v4.0?

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Five Potential Problems to Avoid when Creating a Structured Product Label (SPL)

In the scheme of a large submission such as an original New Drug Application (NDA), the accompanying Structured Product Label (SPL) is often an afterthought. Small in scope should not be confused for simple – the SPL ranks as the most complex piece of your submission. The SPL standard is based on extensible markup language (XML), and the intricacies of this format are difficult to grasp. If you are unfamiliar with XML the probability...

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eCTD Tips & Tricks Part II
Oct06

eCTD Tips & Tricks Part II

Getting to the heart of the matter, operations functions of all shapes and sizes exist – and so do solutions to meet those needs. While it is true that you can create a valid eCTD with some very simple and inexpensive software tools, there is no way I would want to do it by those means.

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How to Fix Common Study Tagging File XML Errors
Apr11

How to Fix Common Study Tagging File XML Errors

Study Tagging Files XML is a very common area of confusion for most people new to eCTD and XML in general. I have spent a lot of time creating the XML for sequences by hand, and have examined sponsors’ XML to determine the location of the error. Because of these experiences, I thought it would be beneficial to discuss the basic structure of the index.xml, stf.xml, and the single most common question I receive related to the STF which is, “Why am I seeing errors 1952, 1953 and are these the same error?”

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Comparing XML in RPS, eCTD

Recently, I was providing some training to a GlobalSubmit client and one of the participants asked me about an xml document that was present in a folder along with the sample eCTD that we use for training. The document was called “porp.xml”. I explained that GlobalSubmit’s VALIDATE product can transform eCTD into RPS and when it does, it produces the XML backbone used for RPS, which is called porp.xml. This is a single xml document...

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