Archive for March, 2009
What You Need to Know to Create High Quality Electronic Documents
Submitting regulatory documents electronically to the FDA is beneficial for sponsors and regulatory reviewers, but the use of electronic submissions brings with it a set of problems associated with how these documents are read by reviewers. Though submitting documents electronically is no longer new, technology continues to evolve, thus changing the ways regulatory reviewers approach [...]
What Reviewers Need to Know About the Regulatory Reader, cont.
In a post earlier this week I started a discussion on my observations of a project development teams’ approach to document review. I suggest that what I observed this team do and not do as their focus in the review process is pretty typical of “ways of working” across most organizations. One of the big [...]
Medical and Pharmaceutical Writers Must Use Knowledge Management Tools To Create Their Documents
In a past blog post I mentioned that full-time writers in the life sciences must see themselves as much more than just writers. I argued that writers engaged in pharmaceutical, device, and clinical research must see themselves as knowledge managers, not merely the managers of data or the “shapers” of information. I have argued that [...]