This article covers sample Roles of Biostatisticians in Drug and Device Development Reflection.
The Roles of Biostatisticians in Drug and Device Development: From Study Design to Regulatory Submission “ Nancy Stambler, DrPH National Public Health Week Wednesday, April 7, 2021 https://touro.box.com/s/d6nph986wjghemipvxuvfefhskatifp2
Reflection that focuses on three key takeaways from the session
Roles of Biostatisticians in Drug and Device Development Reflection
Biostatisticians in drug and device development are more concerned about data than the processes involved therein. Therefore, I learned about their key roles in managing data and product development as it relates to improving their professional fields. Biostatisticians are mandated to design and implement studies by building databases and ensuring data collected is efficient and reliable.
Apart from establishing sample sizes and analyzing programs, statisticians focus on the types of data collected, how it is collected, and presentation methods to achieve product approval from various regulatory institutions. I believe that Biostatisticians should focus more on this fundamental role because it is crucial in determining the success of other processes.
Teaching involves imparting knowledge and enhancing learning conditions. Statistician disseminates knowledge among team members, executives, and students. I think that this initiative is aimed at making members of a specific institution cognizant of pharmaceutical development processes.
In most cases, statisticians expound on statistical methods and applications while also explaining changes in regulatory guidance. For students interested in drug and device development, they understand critical applications and processes, hence can carry on the profession in the future.
Regulators play a vital role in ensuring pharmaceutical development processes are fulfilled. In my studies, I noted that Biostatistician activities are guided by regulatory frameworks, making it necessary to engage regulators regularly to ascertain the extent of product development and the possibility of approval. I contend initiating more meetings with regulars, especially during pre-submission, during, and after review periods.
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I believe that early engagements are essential to both biostatisticians and regulators. It allows them to establish common grounds, identify additional elements needed in submissions, and support data and program analyses. This provides for clarifications on product labeling and verification of content.
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