Assignment
Please use the link attached to answer the question.
Please read FDA's risk-based approach guidance and EMA's reflection paper on risk-based approach to quality management. Both are also posted within the BlackBoard system and can be found on FDA and EMA's website. Please answer the following questions:
• How are these documents similar? How different? Provide a brief summary of each that allows for this comparison.
• After reviewing these guidance documents do you believe taking a risk-based approach involves ‘taking short-cuts'? Why or why not?
• Do you believe it is possible to achieve a higher level of quality by taking a targeted approach to data review as opposed to implementing 100% review strategy? Why or why not?
Please provide a two page paper addressing the above-referenced questions
Attachment:- Links.rar