IQVIA RIM Smart - Regulatory Information Management
IQVIA RIM Smart. Intelligence, automation and integration.
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EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Middle East & Africa
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Americas
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Asia & Oceania
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Europe
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Middle East & Africa
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Asia & Oceania
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Europe
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EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more -
Middle East & Africa
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
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Data is the focus for regulatory submissions
Jan 06, 2022
The adoption of structured content is a significant change for life science companies whose regulatory processes have been traditionally focused on detailed paper document submissions for compliance purposes. This shift really began to regain momentum in earnest when the pandemic forced firms to shift to a remote operations model. With information stored electronically, remote teams can be just as effective in processing regulatory applications as if they were in the office. And since this remote model has now been proven, it is highly likely that the industry will continue to move away from the traditional document centric method.
For those firms who have global operations, it has been a welcome change as more alignment is beginning to occur in how information is captured and reported in readily consumed formats. When everyone enters data in a similar manner, and distributes information in the same fashion, it creates greater alignment and efficiency for compliance purposes. Whether it is the safety team or the regulatory business unit, comprehensive information can be quickly generated and distributed to various audiences.
Rather than recreating the wheel for each individual submission, fragments of content can be stored in a database where teams can pull the approved information to create whatever output form is needed. This goes a step beyond just moving from paper to electronic submissions. By repurposing content into new formats, it streamlines the regulatory process – including for labeling purposes – to add greater operational efficiency. It changes the entire process of how data is captured, standardized and used from beginning to end and allows companies – even larger, global firms – to be more agile when industry shifts occur.
Now, some may wonder if the use of data in this format will be accepted by regulatory agencies. The simple answer is: yes! Many health agencies are starting to implement programs that focus more on the data in applications rather than the accrual of content. And with these electronic forms, the filing process for regulatory and labeling compliance is faster. For those who focus on labeling – which has sometimes been considered an ad hoc part of the regulatory process – it brings this area to the forefront.
Thus, we will see life science firms continue to put more focus on data quality and governance this year to ensure that only quality information is gathered, formatted and entered correctly into the databases for use. And for data governance, it not just about the inputting of the information, but doing it in a way that is controlled and concerns the right and relevant data. We want to avoid the concerns often heard surrounding data entry of “garbage in, garbage out.” The challenge will be putting more of a framework in place around data management and implementing the proper processes and systems.
By taking proactive steps to incorporate data into all regulatory and labeling operations, firms avoid retroactively planning to recapture information. It also future-proof the process to meet the needs for current and new regulations.
For more information, please visit the IQVIA RIM Smart page. For additional questions, please send an email to RegulatoryTechnology@iqvia.com.
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