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Questions and Answers
What is the main purpose of descriptive modelling in data mining?
What is the main purpose of descriptive modelling in data mining?
Which of the following is utilized in diagnostic modelling?
Which of the following is utilized in diagnostic modelling?
Which modelling technique predicts future events based on historical data?
Which modelling technique predicts future events based on historical data?
What does prescriptive modelling aim to do?
What does prescriptive modelling aim to do?
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Which method is NOT part of the PV analytics statistical techniques?
Which method is NOT part of the PV analytics statistical techniques?
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Which of the following accurately describes prescriptive modelling?
Which of the following accurately describes prescriptive modelling?
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What type of analytics helps to uncover reasons behind success or failure?
What type of analytics helps to uncover reasons behind success or failure?
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Which statistical technique is commonly associated with predictive modelling?
Which statistical technique is commonly associated with predictive modelling?
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What is the primary function of regulatory authorities in public health?
What is the primary function of regulatory authorities in public health?
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Which of the following tools is primarily used for understanding complex data relationships visually?
Which of the following tools is primarily used for understanding complex data relationships visually?
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What key obligation do pharmaceutical companies have regarding pharmacovigilance systems?
What key obligation do pharmaceutical companies have regarding pharmacovigilance systems?
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What is a crucial role of the SFDA in KSA?
What is a crucial role of the SFDA in KSA?
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What type of information is essential for detecting specific trends in data analysis?
What type of information is essential for detecting specific trends in data analysis?
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Which statement best describes a regulatory authority's and pharmaceutical companies' obligations?
Which statement best describes a regulatory authority's and pharmaceutical companies' obligations?
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What is one of the primary outcomes students should achieve from this lecture?
What is one of the primary outcomes students should achieve from this lecture?
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What process is involved in ensuring the safe use of medicinal products by the SFDA?
What process is involved in ensuring the safe use of medicinal products by the SFDA?
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What is the foundational concept for many disproportionality methods?
What is the foundational concept for many disproportionality methods?
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Which database can be used to obtain expected counts for drug-event combinations?
Which database can be used to obtain expected counts for drug-event combinations?
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How can GIS assist in monitoring healthcare-related issues?
How can GIS assist in monitoring healthcare-related issues?
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What are some uses of GIS in public health?
What are some uses of GIS in public health?
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What is one benefit of using GIS for tracking potential safety problems?
What is one benefit of using GIS for tracking potential safety problems?
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Which of the following best describes the capability of GIS in relation to patient data?
Which of the following best describes the capability of GIS in relation to patient data?
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What aspect of patient safety do disproportionality methods specifically focus on?
What aspect of patient safety do disproportionality methods specifically focus on?
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What is a significant outcome of using multiple layers of information in GIS?
What is a significant outcome of using multiple layers of information in GIS?
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What is a requirement for retaining pharmacovigilance data related to authorized medicinal products?
What is a requirement for retaining pharmacovigilance data related to authorized medicinal products?
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Which organization is responsible for recognizing public health emergencies in conjunction with the Saudi Health Authorities?
Which organization is responsible for recognizing public health emergencies in conjunction with the Saudi Health Authorities?
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How long should essential documents describing the pharmacovigilance systems be kept after termination?
How long should essential documents describing the pharmacovigilance systems be kept after termination?
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What is one of the main activities of the WHO's international collaborative program on drug safety?
What is one of the main activities of the WHO's international collaborative program on drug safety?
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What should the pharmacovigilance systems be adaptable to?
What should the pharmacovigilance systems be adaptable to?
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Where does the WHO's Uppsala Monitoring Centre coordinate its activities?
Where does the WHO's Uppsala Monitoring Centre coordinate its activities?
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How are pharmacovigilance requirements for public health emergencies addressed?
How are pharmacovigilance requirements for public health emergencies addressed?
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What does the SFDA publish regarding pharmacovigilance?
What does the SFDA publish regarding pharmacovigilance?
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What is the primary function of ‘Vigimed’?
What is the primary function of ‘Vigimed’?
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Which organization has been influential in shaping pharmacovigilance legislation since the late 1980s?
Which organization has been influential in shaping pharmacovigilance legislation since the late 1980s?
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What is the purpose of the International Conference on Harmonization (ICH)?
What is the purpose of the International Conference on Harmonization (ICH)?
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Which of the following is NOT one of the broad categories of ICH guidelines?
Which of the following is NOT one of the broad categories of ICH guidelines?
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Who provides training and support to countries establishing pharmacovigilance systems?
Who provides training and support to countries establishing pharmacovigilance systems?
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What type of meeting involves representatives from collaborating centers for discussing scientific matters?
What type of meeting involves representatives from collaborating centers for discussing scientific matters?
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Which of the following accurately represents the relationship between ICH and regulatory authorities?
Which of the following accurately represents the relationship between ICH and regulatory authorities?
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Which category does NOT typically fall under ICH guidelines?
Which category does NOT typically fall under ICH guidelines?
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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.
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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.
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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.
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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.
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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.
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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.
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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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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.
