Did you know that the PDA has a publication available on their website, called PDALetter? This publication has articles submitted from some of the experts in the field of parenteral drug development and manufacturing.
In February 2024 - Maria Jacobs, Katie Bevard and Jason Kerr connected to provide a comprehesive review of Regulatory Intellgence - Exploring Tools and Program Maturities.
In the fast-evolving field of biopharmaceuticals, regulatory intelligence professionals rely on a suite of tools to stay current with regulatory changes. These tools are categorized for distinct functions: monitoring regulatory information, capturing and distributing information, business and risk assessment attributes, tracking assessments, and metrics reporting. Monitoring is managed through newsletters, RSS feeds from agencies, and website monitoring tools like Website Watcher, Change Tower, and VisualPing. For capturing and disseminating information, professionals use a mix of methods from simple emails and spreadsheets to advanced cloud-based platforms and specialized tools such as Jira or Smartsheet.
The assessment of business impact and risk is performed by teams with the ability to discern the relevance of regulatory updates, engage with subject matter experts, and prioritize information effectively. Tools that facilitate the tracking of assessments help monitor the quantity and impact of reviewed information, as well as the progression of SME assessments through various statuses, ensuring GMP compliance. For reporting, sophisticated tools like Tableau and Power BI collate and present metrics, reflecting the maturity of a regulatory program.
Looking to the future, the article anticipates a shift towards greater automation in regulatory intelligence, especially through the use of AI. While AI promises increased efficiency in processing regulatory data, thereby freeing professionals for high-value work, the technology is not without pitfalls. The industry is advised to proceed cautiously, ensuring that AI's integration into regulatory intelligence is approached with a risk-based strategy to prevent the adoption of potentially erroneous information.
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