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CPSR Part B
Signed by the Safety Assessor
A person with a degree or other formal qualifications awarded by University, after theoretical and practical studies in pharmacy, toxicology, medicine or a similar discipline, or an equivalent by a Member State.
He should be independent from the manufacturing and marketing.
The Safety Assessor shall collaborate with the Responsible Person to ensure that the safety assessment is properly valuated and documented and that the assessment is updated.
Thus, the Responsible Person has the responsibility for scientific and technical aspects putting in charge a qualified Safety Assessor, who fully supports the RP on scientific and technical issues.