CPSR Part B

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CPSR Part B

Safety Assessment

Signed by the Safety Assessor

A person in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognised as equivalent by a Member State
Should be independent from the manufacturing and marketing

The Safety Assessor should work closely together with the Responsible Person to ensure that the safety of the product is properly assessed and documented and that the assessment is kept up to date
Thus, the Responsible Person is in charge for all scientific and technical aspects through the appointment of qualified Safety Assessor, which will fully support the Responsible Person for issues relating to scientific and technical part