is being presented by Michael Attella, Senior Regulatory Medical & Scientific Writer, Medical Composition Resources, LLC and airs on Tuesday, May 18th, 2010. For more details or to register, please visit our site at www.fxconferences.com
In an NDA, CTD or BLA, the Clinical Study Report (CSR) can be viewed as a building block for other more integrative and larger-scope regulatory-formatted documents (RFD) like the Integrated Summaries of Safety and Efficacy and even Investigator Brochures. It makes sense then, to train your quantitative writing skills (non-Protocol-oriented, and Results-based) on this most important process.
However, the majority of Regulatory Medical Writers (RMWs) will agree that this skill transcends the ability to write structurally correct grammatical sentences. Unfortunately, the available “how-to” sources for writing RFDs such as CSRs merely reiterate what the FDA sets out in very general descriptive paragraphs in such Guidances as the key E3 [1996] Structure and Content of Clinical Study Reports. There is a method to employ, which, until recently, has only come with experience. This audio conference will detail three of the several facets entailed when writing (and then routing for review) a Phase I, First-in-Humans safety report.
