By Linda Fossati Wood (auth.), Linda Fossati Wood, MaryAnn Foote (eds.)
This booklet describes the authors’ usual or ‘best’ practices utilized in writing regul- ed medical files for the drug and biologics undefined. the elemental premise of this ebook is that the top (documents submitted to a future health authority) is dep- dent at the starting (the making plans and approach that pass into organizing written documentation). each one regulatory record inherently exists inside a constellation of comparable files. This booklet makes an attempt to teach the relationships among and between those files and indicates concepts for organizing and writing those records to maximise ef?ciency whereas constructing transparent and concise textual content. always, and without reference to appropriate legislation and instructions, strong verbal exchange abilities and a feeling of stability are necessary to accurately, safely, and obviously describe a product’s features. At no time may still the reader understand those feedback to be the one potential way to writing regulatory records nor should still the reader anticipate that those feedback warrantly product good fortune. The viewers for this publication is the amateur scientific author, or those that wish to discover or increase regulatory-writing abilities. We imagine the reader may have a uncomplicated realizing of written communique, yet little adventure in using this ability to the duty of regulatory writing. huge wisdom of technological know-how, scientific me- cine, arithmetic, or regulatory affairs legislations isn't really required to exploit the easiest practices defined during this book.
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Additional resources for Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics
It also focuses on the use of both paper ﬁles and electronic documents for regulatory submissions and on the creation and maintenance of templates and a style guide. Document templates Templates are a key component of a well-organized regulatory submission and fall into two categories: u Instructional templates: Instructional templates provide the writer with instructions for writing sections of the document based on regulatory guidelines and the sponsor’s interpretation of the regulatory guidelines.
Deﬁne all terms at ﬁrst use in each section to assist the various reviewers. Side bar: Lessons learned It is always wise to avoid abbreviations when possible and to avoid all nonstandard abbreviations. The final protocol (or other part of the submission) should not read like alphabet soup. Although we often use abbreviations and jargon within our teams, we need to remember that the data and concepts are new and possibly unfamiliar to the reviewer. Do not make the reviewer guess what you mean or wonder whether the abbreviation ND means ‘not determined’ or ‘no difference’.
Precise heading titles and the order of topics within the template may vary by sponsor and by product. Additionally, the depth of coverage of a topic is subject to interpretation by the sponsor. Thus, two sponsors can have different interpretations of a single section of a guidance document, or they might choose to implement selective portions of the guidance. The danger, of course, is in not providing information that regulatory agencies expect to ﬁnd. Guidance documents, while somewhat ﬂexible, occasionally contain redundant sections.