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

16 Questions | Total Attempts: 20

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

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Questions and Answers
  • 1. 
    According to Directive 2001/83/EC, Article 10(1), the concept of bioequivalence is
    • A. 

      Optional

    • B. 

      Fundamental

    • C. 

      Situational

    • D. 

      All of the above

  • 2. 
    Presenting the bioanalytical summary table is mandatory as per which EMA guideline below?
    • A. 

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

    • B. 

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

    • C. 

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

    • D. 

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

  • 3. 
    Which document is compulsory to present in module 1 administrative part (based on directive) of regulatory dossier by sponsor?
    • A. 

      Clinical expert declaration

    • B. 

      Information relating to clinical trials

    • C. 

      Quality expert declaration

    • D. 

      Similarity declaration

  • 4. 
    Protocol deviation falls under which category of GCP inspection finding?
    • A. 

      Major

    • B. 

      Minor

    • C. 

      Critical

    • D. 

      None of the above

  • 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.
    • A. 

      True

    • B. 

      False

  • 6. 
    What is the range for Cmax  for Narrow Therapeutic Index Drugs (CI Log Transformed Data) for study submission in Europe Medicines Agency?
    • A. 

      69.84 – 143.19 %

    • B. 

      90.00 – 111.11 %

    • C. 

      80 – 125 %

    • D. 

      None of the above

  • 7. 
    Which of the following studies are mandatory for Modified Released Dosage Forms as per EMA?
    • A. 

      Fast condition

    • B. 

      Fed condition

    • C. 

      Fast, Fed and Steady State

    • D. 

      Fast and Fed

  • 8. 
    For National Procedure: Procedural timetable exists. Day 0-90, Day 40, Day 60, Day 90
    • A. 

      True

    • B. 

      False

  • 9. 
    Most of the critical findings of CSR category are related to:
    • A. 

      Large number of major protocol deviations not reported in the CSR

    • B. 

      Inadequate monitoring activities performed at site

    • C. 

      None of the above

  • 10. 
    The inspection generally involves
    • A. 

      Facility tour to evaluate site infrastructure, SOPs and processes

    • B. 

      Archival-storage area: for documents, the security, pest, humidity, and fire controls

    • C. 

      Labs tour: equipment, process, calibrations, quality control methods, accreditation, training

    • D. 

      Pharmacy: Investigational drug storage-accessibility, security, storage conditions, temperature records, calibrations, stock checks, labeling, accountability logs

    • E. 

      All of the above

  • 11. 
    EMA inspection may involve team member interviews – PI, SI, SC, Lab personnel, others.
    • A. 

      True

    • B. 

      False

  • 12. 
    Critical observations are considered totally unacceptable.
    • A. 

      True

    • B. 

      False

  • 13. 
    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”
    • A. 

      Critical

    • B. 

      Major

    • C. 

      Minor

    • D. 

      All of the above

  • 14. 
    Centralized Procedure (CP): Pathway to seek for MA grant of the Commission in all member States.
    • A. 

      True

    • B. 

      False

  • 15. 
    Key considerations for eCTD dossier compilation.
    • A. 

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

    • B. 

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

    • C. 

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

    • D. 

      All of the above

  • 16. 
    Which of the following is not true for eCTD dossier compilation?
    • A. 

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

    • B. 

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

    • C. 

      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)

    • D. 

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

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