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Indicate whether the statement it is CORRECT or INCORRECT. Provide an explanation of the reasoning behind your answer (2 marks). Please note there could be more than one correct/incorrect statement.In pharmacovigilance, a potential risk refers to an undesirable clinical outcome for which there is sufficient scientific evidence that the medicinal product causes it.

An example of a potential risk is

What is the role of Post-Authorisation Safety Studies (PASS) in pharmacovigilance?

Predictive pharmacovigilance focuses on

A risk management plan is based on the principles of the 

Which of the following is a key consideration in benefit-risk assessments for paediatric populations?

In pharmacovigilance, signal validation is best defined as the process of

Section 2B (1) of the Medicines and Related Substances Act requires the South African Health Products Regulatory Authority (SAHPRA) to

According to the World Bank system, pharmacovigilance rests on the following pillars, EXCEPT:

Which of the following benefit-risk assessment frameworks quantitatively incorporates preference weights from different stakeholders, including patients, for key outcomes?