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Section A- two points As part of risk minimization approaches, there is Restric

April 19, 2024

Section A- two points

  • As part of risk minimization approaches, there is Restricted access- Manufacturing
  • restrictions (Three types)

  • Mention and describe the three types, writing advantages and disadvantages of each type
  • Give an example of name of two medications that had restricted access Manufacturing restrictions
  • Use the lectures slides on ‘Risk minimization and risk management’; as well as Chapter III in: Council for International Organizations of Medical Sciences (CIOMS) 2014. Practical approaches to risk minimization for medicinal products: Report of CIOMS Working Group IX.
  • https://cioms.ch/sd7fdh93gewd882ds/jkdf79ds7dl092dq-purple- book/CIOMS_IX_Risk_minimisation_SECURED_20140811v8.pdf
  • Section B- 1.5 points

    Bring an example, from your experience, about two situations in which you were faced with needing to implement the use of recommended risk minimization approach.

    If helpful: Use: https://www.sfda.gov.sa/en/RMM

  • When was this approximately?
  • What was the medication involved? What was the indication?
  • Without giving any patient identifiers, tells us a bit of a background on the patient’s medical state where relevant.
  • What was the risk minimization approach involved, and why was this particular RMM chosen?
  • Was there any follow up
  • With your group, read and go over the conference poster entitled “Saudi FDA approved Risk Minimization Measures: A descriptive overviewhttps://twitter.com/ispegrig/status/14304746443568…Authors: Albogami Y, Alshehri S, Alkhaibri A
  • What was the name of this conference? What society is it affiliated with?
  • Discuss the methods used- for example was the data collected retrospectively or prospectively?
  • Go over the main findings of this research.
  • Then be prepared to write a summary of the abstract- very brief.
  • What are medications that have RMM recommend patient registries
  • according to SFDA website? Have any been added as a recommendation

    since the dissemination of this study?

  • Debate the findings in context; mention your opinion.
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