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