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Regulatory writing for the veterinary pharmaceutical industry is in many ways similar to other types of regulatory writing, but there are also clear differences. This article outlines the veterinary regulatory structure in Europe and, in particular, dossier content, competent regulatory authorities, as well as registration procedures. Adjacent fields of regulatory writing are addressed and an overview of typical documents is given. Furthermore, specific veterinary regulatory information sources for medical writers are provided. [ABSTRACT FROM AUTHOR]

Good Regulatory Practice is a regulatory affairs quality standard that is based on trained people who understand their professional role and work in an environment that follows standards and processes. This article illustrates the diversity of roles represented by a regulatory affairs professional and explains the importance of focused training of personnel, and of generating departmental regulatory intelligence. Good Regulatory Practice is a prerequisite for achieving an optimal balance between regulatory requirements, anticipated target profile, and time to market. [ABSTRACT FROM AUTHOR]

Background: Shared decision making (SDM) is a core element in the meeting between patient and healthcare professionals, but has proved difficult to implement and sustain in routine clinical practice. One of five Danish regions set out to succeed and to develop a model that ensures lasting SDM based on learnings from large-scale real-world implementation initiatives that go beyond the 'barriers' and 'facilitators' research approach. This paper describes this process and development of a generic implementation model, SDM:HOSP. Methods: This project was carried out in the Region of Southern Denmark with five major hospital units. Based on existing theory of SDM, SDM implementation, implementation science and improvement methodology, a process of four phases were described; development of conceptual elements, field-testing, evaluation, and development of the final implementation model. The conceptual elements developed aimed to prepare leaders, train SDM teachers, teach clinicians to perform SDM, support development of patient decision aids, and support systematic planning, execution and follow-up. Field testing was done including continuous participant evaluations and an overall evaluation after one year. Results: Data from field testing and learnings from the implementation process, illustrated the need for a dynamic and easy adjustable model. The final SDM:HOSP model included four themes; i)Training of Leaders, ii) Training of Teachers and Clinicians, iii) Decision Helper, and iv) 'Process', each with details in three levels, 1) shared elements, 2) recommendations, and 3) local adaption. Conclusions: A feasible and acceptable model for implementation of SDM across hospitals and departments that accounts for different organizations and cultures was developed. The overall design can easily be adapted to other organizations and can be adjusted to fit the specific organization and culture. The results from the ongoing and overall evaluation suggest promising avenues for future work in further testing and research of the usability of the model. [ABSTRACT FROM AUTHOR]

The article offers information on writing practice and style in medical writing. One of the authors states that she has been battling against redundant modifiers, verbosity, and buzz words as an editor and mentions that some authors use lap up snappy new terminology with alacrity. It mentions the alarming tendency on the increase of paragraphing on web pages. It also discusses the general rule in using abbreviations in medical writing.