regulatory affairs/Quality Assurance Unit Responsibilities

Description: You are the director of regulatory affairs at a startup pharmaceutical company that has
licensed two drugs that will be evaluated in Phase II clinical studies. Your management has
requested that you outline the responsibilities of a Quality Assurance Unit that has oversight on
compliance of clinical trial activities, manufacturing activities, and nonclinical (toxicology) activities.
Question 1) BRIEFLY outline a few of the important responsibilities that the QA unit should have for
helping to ensure clinical trial GCP compliance. Please do not discuss the responsibilities of clinical
research associates or of investigators. Focus on what the QA specialist will do to complement the
activities of the clinical research staff.
Question 2) BRIEFLY outline a few of the important responsibilities that the QA unit should have for
helping the toxicologist ensure GLP compliance. Again, do not discuss the responsibilities of the
toxicologist. Focus on what the QA specialist will do to complement the activities of the toxicologist.
For simplicity, we will narrow the question to toxicology although some other preclinical studies fall
under GLP regulations, e.g., toxicokinetics
3) BRIEFLY outline a few of the important responsibilities that the QA unit should have for
helping the chemistry, manufacturing, and controls (CMC) staff ensure GMP compliance. Again,
focus on what the QA specialist will do to complement the activities of the CMC staff.

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