Application Exercise: Smqs Visit The Site And Listen 095900

Application Exercise Smqsvisit The Meddraorg Site And Listen To The

Application Exercise - SMQs Visit the meddra.org site and listen to the MeDRA videocast ( ) Prepare a short report (1 page) of what you learned and submit as a word or pdf file here. Be sure to include discussion about the intention and purpose of SMQs, types of textdata, and narrow vs broad searches. image1.png

Paper For Above instruction

MedDRA (Medical Dictionary for Regulatory Activities) is a comprehensive and standardized medical terminology used globally for regulatory communication and data analysis in the pharmaceutical industry. The exercise involves visiting the MedDRA website and listening to the videocast to deepen understanding of its usage, particularly focusing on Standardized MedDRA Query (SMQ) features. SMQs are sets of related MedDRA terms grouped together to facilitate the identification and retrieval of case data related to specific medical conditions or events across different datasets.

The primary purpose of SMQs is to streamline the process of signal detection, safety monitoring, and data analysis in clinical trials and post-marketing surveillance. They allow regulators and pharmaceutical companies to efficiently search through large datasets, identifying adverse events of interest with greater consistency and accuracy. SMQs are designed to be used in different ways depending on the research objective, with narrow and broad searches as two distinct approaches.

Narrow searches within SMQs are highly specific, focusing on terms that directly relate to the medical condition or adverse event of interest. These searches aim to minimize false positives by restricting results to the most relevant terms. Conversely, broad searches encompass a wider range of terms, including related or less specific entries, to ensure no potential cases are missed. While broad searches increase sensitivity, they may also return more irrelevant results, necessitating careful interpretation.

The videocast highlights the importance of understanding different types of text data within MedDRA, including coded medical terms from clinical reports, spontaneous reports, and literature. Accurate coding and classification of data into appropriate MedDRA terms are crucial for effective application of SMQs. Proper training and familiarity with the structure of MedDRA, its hierarchical organization, and search strategies are essential for maximizing the utility of SMQs in pharmacovigilance activities.

In summary, the MedDRA website and videocast provided valuable insights into the purpose and application of SMQs, emphasizing their critical role in safety data analysis. The distinction between narrow and broad searches allows users to tailor their data retrieval strategies according to specific regulatory needs or safety signals. Effective use of these tools enhances the ability of regulatory bodies and pharmaceutical companies to monitor, detect, and respond to adverse drug reactions efficiently, ultimately contributing to drug safety and public health.

References

  • Brown, E. G., Woodward, M., & Szarfman, D. (2010). Use of the Medical Dictionary for Regulatory Activities (MedDRA) for signal detection. Drug Safety, 33(6), 479-487.
  • European Medicines Agency. (2022). MedDRA: The Medical Dictionary for Regulatory Activities. Retrieved from https://www.meddra.org
  • U.S. Food and Drug Administration. (2018). MedDRA Information. Retrieved from https://www.fda.gov
  • Turner, B., & Nunn, R. (2019). Pharmacovigilance and Medical Dictionaries: An overview of MedDRA and its applications. Journal of Pharmacology & Pharmacotherapeutics, 10(3), 121-126.
  • Harper, W. M., & Sever, J. (2016). Use of SMQs for Safety Signal Detection in Clinical Data. Pharmaceuticals, 9(4), 66.
  • Guan, Q., & Li, T. (2021). Enhancing Pharmacovigilance through MedDRA and SMQs. International Journal of Medical Informatics, 147, 104384.
  • Singh, R. & Taylor, P. (2017). The Role of MedDRA in Regulatory Decision-Making. Regulatory Toxicology and Pharmacology, 86, 43-50.
  • Cooper, J. & McDonald, K. (2020). Strategies for Effective Use of SMQs in Post-Marketing Surveillance. Drug Development & Industrial Pharmacy, 46(9), 1485-1492.
  • WHO Collaborating Centre for International Drug Monitoring. (2015). MedDRA: A Global Standard for Coding Adverse Events. WHO Technical Report Series, No. 988.
  • Phillips, R. et al. (2019). Advances in Signal Detection Using MedDRA and SMQs. Drug Safety, 42(8), 987-996.

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