Information for today’s Regulatory Professional
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Regulatory Affairs Analytics Behind every regulatory operations workflow, registration submission, health authority interaction, there lies data ripe for analysis. This data is probably one of the most important resources a life science organisation can possess. Utilising analysis of this regulatory data can help drive change with positive outcomes to support increases in efficiency and revenue […]
Working from home during lockdown does have some advantages. During the past few weeks I have viewed or participated in a number of virtual discussion sessions and educational webinar presentations across different timezones. I do have to say that the quality of the content and level of professionalism has varied widely. Every day, I receive […]
Human families come in all shapes, sizes, colours, genders and ages. However; in the case of medical device categorisation, the definition of a “family” of product codes is entirely up to you…
Today I attended a very informative webinar hosted by British Standards Institute (BSI) on their interpretation of the medical device regulation requirements under Article 117 for drug device combination products marketing in the European Union from 26 May 2021. My objective for attendance was to confirm my understanding of the Article and obtain an interpretation […]
An optimally engineered and collaborative regulatory operations workplace is not a nice to have, but essential for organisational survival and success.