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Questions and Answers
How long does the consultation period typically last?
What is done with the responses received from all parties?
What is done following internal revisions based on feedback?
How are the total number of responses recorded?
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What is distributed to all users via CDs and online updates?
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What is available for those dissatisfied with consultation outcomes?
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What is the function of the Medical Dictionary for Regulatory Activities (MedDRA)?
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Who developed the Medical Dictionary for Regulatory Activities (MedDRA)?
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What does the standardization process involve in relation to MedDRA?
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Which stage of the standardization process involves preparing study protocols and case report forms?
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Who approves the document package internally during the standardization process?
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When a standardization request form is approved internally, where is it then sent?
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Study Notes
Standardization MedDRA Queries
Medical Dictionary for Regulatory Activities (MedDRA) is a medical terminology system used for postmarketing safety data analysis by regulatory authorities worldwide. It is developed by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), which represents over 60 national associations from Europe, Africa, Asia Pacific, Japan, Latin America, North America, and the Middle East. MedDRA provides a controlled list of terms with hierarchical relationships, allowing users to search and retrieve information on drug safety by selecting relevant terms from this list.
The standardization process involves several stages:
Stage 1 - Preparation
This stage includes preparing the relevant documentation, such as study protocols, case report forms, and any additional materials necessary for the standardization reviewer to assess if the queries meet the requirements outlined in the IFPMA's SOP for External Query Submission and Review.
Stage 2 - Internal Review
When the document package is deemed complete, it will be reviewed internally. If the reviewer approves, they will send the standardization request form to the second person in their department for final approval.
Stage 3 - Consultation Request Form
Once approved, the request form will be sent to external parties, including regulatory agencies, industry associations, and other key stakeholders within the pharmaceutical industry. This consultation period lasts approximately two weeks.
Stage 4 - Response Collection
After receiving responses from all parties, they are compiled in a spreadsheet along with comments from each contributor. The total number of responses is recorded in brackets next to the name of the party.
Stage 5 - Query Implementation
Following internal revisions based on the consulted feedback, the query is implemented into MedDRA. The final version is distributed to all users via the MedDRA CDs and online updates.
Additionally, there is an appeal process available for those dissatisfied with the outcome of consultations or decisions made during the standardization.
In summary, the standardization process for MedDRA queries ensures a rigorous and transparent assessment of external requests to maintain the integrity and suitability of the MedDRA dictionary. By following these steps and engaging with various stakeholders, MedDRA can continue to support robust postmarketing surveillance of medicines, ensuring patient safety.
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Description
Learn about the multi-stage process involved in standardizing MedDRA queries, from preparation and internal review to consultation with external parties and query implementation. Understand the importance of maintaining the integrity and transparency of the MedDRA dictionary through rigorous assessment and stakeholder engagement.
