Regulatory Requirements Of Be Studies In Europe - Day 2: Zhejiang Anser Medical Technology Co., Ltd.

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Quizzes Created: 1 | Total Attempts: 48
| Attempts: 48
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  • 1/16 Questions

    The inspection generally involves

    • Facility tour to evaluate site infrastructure, SOPs and processes
    • Archival-storage area: for documents, the security, pest, humidity, and fire controls
    • Labs tour: equipment, process, calibrations, quality control methods, accreditation, training
    • Pharmacy: Investigational drug storage-accessibility, security, storage conditions, temperature records, calibrations, stock checks, labeling, accountability logs
    • All of the above
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About This Quiz

This specialized quiz for Day 2 focuses on the regulatory requirements of bioequivalence studies in Europe, specifically for Zhejiang Anser Medical Technology Co., Ltd. It assesses understanding of critical guidelines, documents, and definitions essential for compliance in pharmaceutical and medical fields.

Regulatory Requirements Of Be Studies In Europe - Day 2: Zhejiang Anser Medical Technology Co., Ltd. - Quiz

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  • 2. 

    EMA inspection may involve team member interviews – PI, SI, SC, Lab personnel, others.

    • True

    • False

    Correct Answer
    A. True
    Explanation
    EMA inspection may involve team member interviews such as Principal Investigators (PI), Study Investigators (SI), Study Coordinators (SC), Laboratory personnel, and others. These interviews are conducted to gather information, clarify any doubts, and ensure compliance with regulations and guidelines. By interviewing different team members, the EMA can assess the overall conduct of the study and identify any potential issues or areas for improvement. Therefore, the statement "EMA inspection may involve team member interviews" is true.

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  • 3. 

    The findings are classified by the GCP Inspectors as _______________ according to the classification of GCP findings described in the “Procedure for reporting of GCP Inspections requested by the CHMP”

    • Critical

    • Major

    • Minor

    • All of the above

    Correct Answer
    A. All of the above
    Explanation
    The correct answer is "All of the above". According to the "Procedure for reporting of GCP Inspections requested by the CHMP," the findings can be classified as critical, major, or minor. This means that any finding during the GCP inspection can fall into one of these categories, indicating the severity or impact of the finding. Therefore, all three options - critical, major, and minor - are valid classifications for the GCP findings.

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  • 4. 

    Key considerations for eCTD dossier compilation.

    • File names, including the extension, must not exceed 64 characters.

    • Folder names must not exceed 64 characters and the total file folder path length must not exceed 180 characters.

    • Files should be legible with Acrobat Reader, version 5.0 or higher

    • All of the above

    Correct Answer
    A. All of the above
    Explanation
    The correct answer is "All of the above" because all three statements mentioned are key considerations for eCTD dossier compilation. The first statement emphasizes the importance of keeping file names within a certain character limit to ensure compatibility and readability. The second statement highlights the limitation on folder names and file path length, which is crucial for organizing and accessing the dossier. The third statement specifies the requirement for files to be legible with Acrobat Reader, ensuring that the dossier can be easily viewed and reviewed. Therefore, all three considerations are necessary for successful eCTD dossier compilation.

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  • 5. 

    A generic medicinal product means a medicinal product which has the same qualitative and quantitative composition in terms of active substance(s) and the same pharmaceutical form as the reference medicinal product and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies.

    • True

    • False

    Correct Answer
    A. True
    Explanation
    A generic medicinal product refers to a medication that has the same active ingredient(s) and is formulated in the same way as the original reference product. In addition, it must undergo bioavailability studies to prove that it is bioequivalent to the reference product. This means that the generic product will have the same rate and extent of absorption in the body as the reference product. Therefore, the statement is true.

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  • 6. 

    Which of the following studies are mandatory for Modified Released Dosage Forms as per EMA?

    • Fast condition

    • Fed condition

    • Fast, Fed and Steady State

    • Fast and Fed

    Correct Answer
    A. Fast, Fed and Steady State
    Explanation
    The studies that are mandatory for Modified Released Dosage Forms as per EMA are Fast, Fed, and Steady State. This means that the drug release from the dosage form needs to be evaluated under fasted conditions, fed conditions, and steady-state conditions. These studies help to assess the drug's performance and effectiveness in different physiological states, such as after a meal or during continuous dosing. By conducting these studies, the regulatory authorities can ensure that the dosage form provides consistent drug release and bioavailability in various scenarios.

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  • 7. 

    Which document is compulsory to present in module 1 administrative part (based on directive) of regulatory dossier by sponsor?

    • Clinical expert declaration

    • Information relating to clinical trials

    • Quality expert declaration

    • Similarity declaration

    Correct Answer
    A. Information relating to clinical trials
    Explanation
    In the module 1 administrative part of the regulatory dossier, it is compulsory for the sponsor to present information relating to clinical trials. This document provides essential details about the clinical trials conducted as part of the drug development process. It includes information such as study design, participant demographics, safety data, and efficacy results. This document is crucial for regulatory authorities to evaluate the safety and efficacy of the drug being submitted for approval.

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  • 8. 

    Critical observations are considered totally unacceptable.

    • True

    • False

    Correct Answer
    A. True
    Explanation
    The statement suggests that critical observations are not allowed and are completely unacceptable. This implies that any form of criticism or negative feedback is not tolerated. Therefore, the correct answer is true, indicating that critical observations are indeed considered totally unacceptable.

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  • 9. 

    According to Directive 2001/83/EC, Article 10(1), the concept of bioequivalence is

    • Optional

    • Fundamental

    • Situational

    • All of the above

    Correct Answer
    A. Fundamental
    Explanation
    The correct answer is "Fundamental". According to Directive 2001/83/EC, Article 10(1), the concept of bioequivalence is considered fundamental. This means that it is an essential concept and plays a crucial role in the evaluation of generic drugs. Bioequivalence determines whether a generic drug is therapeutically equivalent to its reference product, meaning it has the same active ingredient, strength, dosage form, and route of administration. This ensures that generic drugs can be safely substituted for their reference products, providing patients with access to more affordable medications while maintaining the same level of efficacy and safety.

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  • 10. 

    Which of the following is not true for eCTD dossier compilation?

    • Use 'Fast Web View' to ensure optimum performance of the review system

    • The maximum file size for an individual PDF file is 50 MB

    • PDF should be produced wherever possible from a text source, such as MS Word, but if sourced from a scanned original then they must be OCR’d  (Optical Character Recognition)

    • All portrait pages are presented in portrait and All landscape pages are presented in landscape

    Correct Answer
    A. The maximum file size for an individual PDF file is 50 MB
    Explanation
    The given statement is not true because the maximum file size for an individual PDF file is not 50 MB in eCTD dossier compilation.

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  • 11. 

    Most of the critical findings of CSR category are related to:

    • Large number of major protocol deviations not reported in the CSR

    • Inadequate monitoring activities performed at site

    • None of the above

    Correct Answer
    A. Large number of major protocol deviations not reported in the CSR
    Explanation
    The correct answer is "large number of major protocol deviations not reported in the CSR." This means that most of the critical findings in the CSR category are due to a significant number of major protocol deviations that were not properly documented or reported in the CSR (Clinical Study Report). These deviations could include instances where the study protocol was not followed correctly or where there were significant deviations from the planned procedures. These findings highlight the importance of accurate and complete reporting in the CSR to ensure the validity and reliability of the study results.

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  • 12. 

    Protocol deviation falls under which category of GCP inspection finding?

    • Major

    • Minor

    • Critical

    • None of the above

    Correct Answer
    A. Critical
    Explanation
    Protocol deviation falls under the category of Critical GCP inspection finding because it indicates a serious violation or non-compliance with the protocol, which is a fundamental document in clinical trials. Protocol deviations can lead to compromised data integrity, safety concerns for participants, and may impact the validity and reliability of the study results. Therefore, addressing and rectifying protocol deviations is crucial to ensure the ethical conduct and scientific validity of the clinical trial.

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  • 13. 

    What is the range for Cmax  for Narrow Therapeutic Index Drugs (CI Log Transformed Data) for study submission in Europe Medicines Agency?

    • 69.84 – 143.19 %

    • 90.00 – 111.11 %

    • 80 – 125 %

    • None of the above

    Correct Answer
    A. 90.00 – 111.11 %
    Explanation
    The range for Cmax for Narrow Therapeutic Index Drugs (CI Log Transformed Data) for study submission in Europe Medicines Agency is 90.00 – 111.11%.

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  • 14. 

    For National Procedure: Procedural timetable exists. Day 0-90, Day 40, Day 60, Day 90

    • True

    • False

    Correct Answer
    A. False
    Explanation
    The statement is false because the given information does not provide any indication that a procedural timetable exists. Without any mention or details about a procedural timetable, it cannot be assumed that it exists. Therefore, the answer is false.

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  • 15. 

    Centralized Procedure (CP): Pathway to seek for MA grant of the Commission in all member States.

    • True

    • False

    Correct Answer
    A. False
    Explanation
    The statement is false because the Centralized Procedure (CP) is not a pathway to seek for MA grant of the Commission in all member States. The CP is a regulatory procedure used for the authorization of certain medicinal products in the European Union. It involves the European Medicines Agency (EMA) and the national competent authorities of the member states. Under the CP, the EMA evaluates the application for marketing authorization and provides a scientific opinion, which is then used by all member states to make their decision on granting the marketing authorization.

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  • 16. 

    Presenting the bioanalytical summary table is mandatory as per which EMA guideline below?

    • EMA/CPMP/EWP/280/96 Corr1, Nov 2014

    • CPMP/EWP/QWP/1401/98 Rev. 1/ Corr **, Jan 2010

    • Appendix IV of CPMP/EWP/ QWP/1401/98 Rev.1

    • EMEA/CHMP/EWP/192217/2009 Rev. 1/Corr. 2**

    Correct Answer
    A. Appendix IV of CPMP/EWP/ QWP/1401/98 Rev.1

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  • May 15, 2023
    Quiz Edited by
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  • May 15, 2020
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    Milan

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