Viseven

JULY 10, 2024

As a specialized field, medical writing encompasses the creation of various documents, from regulatory submission documents to medical journal articles, that convey critical medical knowledge to diverse audiences. It’s like a bridge connecting the intricate world of medical science to everyday healthcare communication.

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Viseven

AUGUST 7, 2024

This allows pharmaceutical companies to maintain their brand voice and facilitates information sharing. Many aspiring medical writers falsely believe they should market their services only to pharmaceutical and medical device companies. As most documents come in a PDF format, Adobe Acrobat is helpful for this task.

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ISPE

NOVEMBER 1, 2022

International convergence is another area in which the FDA is a participant, including in initiatives related to viral safety (ICH Q5A), CM (ICH Q13), quality risk management (QRM; ICH Q9), analytical procedure development (APD; ICH Q2/14), pharmaceutical product life-cycle management (ICH Q12), and common technical document (ICH M4Q).

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Viseven

DECEMBER 13, 2024

Data collection involved paper forms, diaries, and in-person interviews , which, while essential for documenting symptoms and outcomes, were prone to human error. Maintaining regulatory compliance required extensive documentation and oversight, while handling paper-based data was labor-intensive and prone to mismanagement.

Health and Personal Care Stores 52

Health and Personal Care Stores Communication Documentation Pharmaceutical Companies 52

ISPE

JULY 5, 2023

For example, one pharmaceutical company that switched to CM reported a 50% reduction in operating costs, a 33% reduction in waste, an 80% reduction in manufacturing and testing cycle time, and a 66% reduction in time from testing to release. FDA/M-CERSI Co-Processed API Workshop Proceedings.” National Academies Press, 2021.

FDA 52

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