Blog

At which level of significance can a researcher be the most confident that a real difference exits between two treatments?

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.Ideally, a Risk Management Plan (RMP) should be submitted during the pre-authorisation phase of a product’s life cycle. This is to ensure that all serious risks are identified and managed before a product is authorised for use.

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.Risk evaluation in a periodic safety update report should be based on all uses of the product.

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.During the roll-out of a new vaccine, adverse events of special interest (AESI) are best identified through spontaneous reporting by healthcare workers and vaccinees or their caregivers to determine whether there is a link between the vaccine and the AESI.

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?