Be prepared: FDA looks beyond employee training records during inspections as one FDA investigator states. Are employees suited for their particular position within the organization. Inspectors are looking at the necessary background, the right training, and the right experience levels to do the job functions they are performing. The Gray Sheet, September the 14th.   As an MSL or an MSL leader it is more important to be ready for your role. I can’t emphasis the importance of participating in a certificate led educational MSL program. After the training you need to place the certificates in y ..read more

The role of the MSL has become central in contributing to the success of new pharmaceuticals and medical/diagnostic devices within the healthcare marketplace. Here Nascent Medical discusses the essential elements of MSL selection and training to ensure effectiveness in the field and accelerated capability. The Medical Science Liaison (MSL) function is assuming an ever increasing prominence and importance within the pharmaceutical and medical device/diagnostics industry. The ability for trained individuals with a strong academic and/or professional background in medical science to communicate ..read more

In this blog, I describe information provided in the AMA Manual of Style that covers how to deal with figures. This information is located in Section 1 “preparing an article for publication”, subsection 4: visual presentation of data, and sub-sub section 4.2, there you have the information about figures. Of course, for all the finer details about this topic, please do visit the AMA Manual of Style. Ok, so here is what the AMA Manual of Style has to say about figures. First of all, this section is broken out into several categories. These are 4.2.1 Statistical Graphs 4.2.2 Diagrams 4.2.3 Maps 4 ..read more

This is a checklist for tables so that you can follow the AMA style guide. This is based on information at Section 1 Preparing an Article for Publication, subsection visual presentation of data, 4.1 Tables. If you are fiercely interested in this topic, you should check it out from the source. I have included most but not all of the finer details included there. 1. Make primary comparisons horizontal rather than vertical. During the planning and creation of a table, the author should show the primary comparisons horizontally across the table, which makes them easier to compare. Independent vari ..read more

I’ve been talking a lot about different aspects of the AMA Manual of Style, but I haven’t as yet provided an overview of the contents in their entirety. So, I thought that would be a good thing to do. Perhaps you are new to medical writing and you haven’t really taken a look at the manual. I suggest that you go to the website and take a look. Spend a couple of hours digging in. Some of it makes for quite interesting reading and will certainly be helpful for your day-to-day work. Let’s first go ahead and click on the contents link on the AMA manual of style homepage. Just as a side note, I alwa ..read more

How to format P values in AMA style In this post, I’ll be going over P values and how to express them according to the AMA Manual of Style. Many of you probably already know this, but I’ll first briefly define what a P value is. When you are comparing a treatment with a placebo, for example, you will have a null hypothesis, which states that the treatment is no better than placebo. This is in contrast to the alternative hypothesis, which states that the treatment is better than placebo. A low P value (generally defined as P < .05) suggests that your sample provides enough evidence that you ..read more

A ..read more