Which of the following would typically NOT be included in a PBRER?

The correct answer is that sales strategies for the upcoming year would typically not be included in a Periodic Benefit-Risk Evaluation Report (PBRER). A PBRER is a regulatory document that focuses on the ongoing assessment of the benefit-risk profile of a medicinal product once it is on the market. It is primarily concerned with safety, effectiveness, and overall product performance from a clinical and regulatory standpoint.

Key components of a PBRER include a summary of adverse effects experienced, which provides insights into the safety of the drug; an evaluation of risk vs. benefit, which assesses whether the therapeutic benefits of the drug outweigh the risks associated with its use; and updates on clinical trial phases as relevant to understanding the drug's ongoing development and safety profile.

Including sales strategies would diverge from the primary purpose of the PBRER, which is not concerned with commercial aspects but rather with the safety and efficacy of the drug from a health regulatory perspective. This separation of commercial strategy from regulatory reporting underscores the focused nature of PBRERs in evaluating drug safety without the influence of marketing considerations.