Data Mining in PV and Drug Informatics
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Data Mining in PV and Drug Informatics

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Questions and Answers

What is the main purpose of descriptive modelling in data mining?

  • To forecast future trends and outcomes
  • To analyze historical data for patterns (correct)
  • To recommend actions based on predictions
  • To determine causes of observed trends

    • Which of the following is utilized in diagnostic modelling?

  • Anomaly detection
  • Hypothesis testing (correct)
  • Visualization tools
  • Decision trees

    • Which modelling technique predicts future events based on historical data?

  • Descriptive modelling
  • Diagnostic modelling
  • Predictive modelling (correct)
  • Prescriptive modelling

    • What does prescriptive modelling aim to do?

    <p>Recommend actions based on data</p> Signup and view all the answers

    Which method is NOT part of the PV analytics statistical techniques?

    <p>Simulation modeling</p> Signup and view all the answers

    Which of the following accurately describes prescriptive modelling?

    <p>It recommends actions by integrating various data types</p> Signup and view all the answers

    What type of analytics helps to uncover reasons behind success or failure?

    <p>Descriptive analytics</p> Signup and view all the answers

    Which statistical technique is commonly associated with predictive modelling?

    <p>Regression analysis</p> Signup and view all the answers

    What is the primary function of regulatory authorities in public health?

    <p>To monitor medicinal products and ensure their safe use</p> Signup and view all the answers

    Which of the following tools is primarily used for understanding complex data relationships visually?

    <p>Visualization analytics</p> Signup and view all the answers

    What key obligation do pharmaceutical companies have regarding pharmacovigilance systems?

    <p>To operate and exchange data with regulatory authorities</p> Signup and view all the answers

    What is a crucial role of the SFDA in KSA?

    <p>To coordinate the monitoring of medicinal products</p> Signup and view all the answers

    What type of information is essential for detecting specific trends in data analysis?

    <p>Information from the Internet</p> Signup and view all the answers

    Which statement best describes a regulatory authority's and pharmaceutical companies' obligations?

    <p>Both parties must operate pharmacovigilance systems</p> Signup and view all the answers

    What is one of the primary outcomes students should achieve from this lecture?

    <p>Explaining domestic and global regulatory requirements</p> Signup and view all the answers

    What process is involved in ensuring the safe use of medicinal products by the SFDA?

    <p>Monitoring and validating terminology use</p> Signup and view all the answers

    What is the foundational concept for many disproportionality methods?

    <p>Reporting odds ratio (ROR)</p> Signup and view all the answers

    Which database can be used to obtain expected counts for drug-event combinations?

    <p>FDA Adverse Event Reporting System (FAERS)</p> Signup and view all the answers

    How can GIS assist in monitoring healthcare-related issues?

    <p>By tracking social media trends</p> Signup and view all the answers

    What are some uses of GIS in public health?

    <p>Outbreak investigations and documentation of geographic components</p> Signup and view all the answers

    What is one benefit of using GIS for tracking potential safety problems?

    <p>It provides new opportunities for real-time interventions</p> Signup and view all the answers

    Which of the following best describes the capability of GIS in relation to patient data?

    <p>To visualize and analyze data for patterns and trends</p> Signup and view all the answers

    What aspect of patient safety do disproportionality methods specifically focus on?

    <p>Identifying statistical associations between products and events</p> Signup and view all the answers

    What is a significant outcome of using multiple layers of information in GIS?

    <p>Allowing for systematic addressing of event occurrence</p> Signup and view all the answers

    What is a requirement for retaining pharmacovigilance data related to authorized medicinal products?

    <p>Retention for at least 10 years after marketing authorization expires.</p> Signup and view all the answers

    Which organization is responsible for recognizing public health emergencies in conjunction with the Saudi Health Authorities?

    <p>World Health Organization (WHO)</p> Signup and view all the answers

    How long should essential documents describing the pharmacovigilance systems be kept after termination?

    <p>For at least 5 years after termination.</p> Signup and view all the answers

    What is one of the main activities of the WHO's international collaborative program on drug safety?

    <p>Collecting and communicating information on drug benefits and risks.</p> Signup and view all the answers

    What should the pharmacovigilance systems be adaptable to?

    <p>Public health emergencies.</p> Signup and view all the answers

    Where does the WHO's Uppsala Monitoring Centre coordinate its activities?

    <p>Uppsala, Sweden</p> Signup and view all the answers

    How are pharmacovigilance requirements for public health emergencies addressed?

    <p>They are considered on a case-by-case basis.</p> Signup and view all the answers

    What does the SFDA publish regarding pharmacovigilance?

    <p>Safety announcements and notifications.</p> Signup and view all the answers

    What is the primary function of ‘Vigimed’?

    <p>To facilitate electronic information exchange</p> Signup and view all the answers

    Which organization has been influential in shaping pharmacovigilance legislation since the late 1980s?

    <p>The Council for International Organizations of Medical Sciences (CIOMS)</p> Signup and view all the answers

    What is the purpose of the International Conference on Harmonization (ICH)?

    <p>To harmonize drug development guidelines across regions</p> Signup and view all the answers

    Which of the following is NOT one of the broad categories of ICH guidelines?

    <p>Regulatory (R)</p> Signup and view all the answers

    Who provides training and support to countries establishing pharmacovigilance systems?

    <p>The Uppsala Monitoring Centre</p> Signup and view all the answers

    What type of meeting involves representatives from collaborating centers for discussing scientific matters?

    <p>Annual meeting of collaborating centers</p> Signup and view all the answers

    Which of the following accurately represents the relationship between ICH and regulatory authorities?

    <p>The timing and extent of ICH guideline implementation varies</p> Signup and view all the answers

    Which category does NOT typically fall under ICH guidelines?

    <p>Pharmacokinetics (P)</p> Signup and view all the answers

    Study Notes

    Data Mining in PV and Drug Informatics

    • Descriptive Modelling: Identifies patterns and groupings in historical data, revealing reasons for successes or failures. Uses techniques like anomaly detection and principal components analysis.
    • Diagnostic Modelling: Determines causes of trends and correlations between variables. Helps with hypothesis testing and understanding the difference between correlations and causation.
    • Predictive Modelling: Classifies future events or estimates unknown outcomes. Uses techniques like decision trees.
    • Prescriptive Modelling: Combines data from descriptive and predictive analytics with unstructured data for more accurate predictions. Uses methods like text and web mining to recommend courses of action.
    • Disproportionality Methods: Identifies statistical associations between products and events, especially in patient safety. Compares observed counts with expected counts.
    • Geographic Information Systems (GIS): Used for identifying geographic trends, performing surveillance, visualizing patient locations, and identifying clusters of events. Can incorporate social media data. Important for tracking disease spread, performing outbreak investigations, and providing patient education.
    • Text and Information Mining: Helps detect specific text patterns and combinations, as well as trends, in unstructured data like narratives and event descriptions.
    • Visualization Tools: Uses pictures and graphics to make complex data relationships easier to understand. Useful for displaying multi-source data.

    Domestic and Global Regulatory Requirements

    • Role of Regulatory Authorities: A public health function with the objective to ensure safe and effective use of medications.
    • Role of Pharmaceutical Companies: Similar duties to regulatory authorities, but as a commercial entity, they also have business requirements.
    • SFDA (Saudi Food and Drug Administration)
      • Coordinates the monitoring of medicinal products in KSA.
      • Provides advice on ensuring safe and effective use.
      • Implements legal pharmacovigilance requirements.
    • Specific Quality System Processes of the SFDA:
      • Monitors and validates the use of specific terminology.
      • Assesses and processes pharmacovigilance data within legal timelines.
      • Ensures effective communication of safety announcements.
      • Maintains documentation of pharmacovigilance systems
      • Retains pharmacovigilance data as long as a product is marketed.
    • Preparedness Planning for Public Health Emergencies:
      • Emphasizes adaptability of pharmacovigilance systems to public health emergencies.
      • Requires case-by-case assessments and notifications to marketing authorization holders.
      • Publishes notifications on the SFDA website.
    • WHO's International Collaborative Program on Drug Safety:
      • Established in 1968 with a monitoring center in Uppsala, Sweden.
      • Collects, assesses, and communicates information about medication benefits and risks.
      • Develops and implements pharmacovigilance practices.
      • Alerts regulatory authorities about potential drug safety problems.
      • Uses 'Vigimed' for electronic information exchange.
      • Publishes regular newsletters and manages the WHO Drug Dictionary and WHO Adverse Reaction Terminology (WHOART).
      • Provides training and support to countries establishing pharmacovigilance systems.
      • Organizes annual meetings for collaborating center representatives.
    • **Council for International Organization of Medical Sciences (CIOMS): **
      • Based in Geneva and operates under the WHO umbrella.
      • Serves as a forum for discussions between regulators and industry on pharmacovigilance topics.
      • Has been influential in shaping legislation and guidelines globally.
    • International Conference on Harmonization (ICH):
      • A formal group with a wider remit for harmonization across the drug development process.
      • Has also been influential in shaping regulatory requirements for pharmacovigilance.
      • Represents regulators and industry from the EU, USA, and Japan.
      • Has observers from the WHO.
      • Harmonizes guidelines related to drug development and registration.
    • ICH Guidelines
      • Cover four categories: Quality, Safety, Efficacy, and Mutil-disciplinary.
      • Authorities in all territories commit to implementation, though timing and extent vary.

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    1728287121016-Lecture_6_and_7.pdf

    Description

    Explore the various modeling techniques used in data mining for pharmacovigilance and drug informatics. This quiz covers descriptive, diagnostic, predictive, and prescriptive modeling strategies as well as disproportionality methods and geographic information systems. Test your knowledge of how these methods enhance drug safety and efficacy analysis.

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