Considering drug safety in an isolated way, i.e., not integrating the drug benefits into a BR statement has been detrimental to patients and the pharmaceutical industry. Over the last years regulatory authorities, patient interest groups and the industry have become more and more interested in structured approaches to benefit risk management.
The change in the structure of the PSUR to a Periodic Benefit-Risk Evaluation Report complementing the Risk Management Plan is probably the most important example of how benefit-risk thinking is integrated into the lifecycle management of a drug. Several methodologies available for the qualitative and (semi-)quantitative analysis of benefit-risk profiles are going to be discussed, including their relative advantages and disadvantages. Finally, we are going to cover reasons why the decision framework for BR may change post-approval and how to address these changes in order to maintain a favorable BR balance.
Why should you Attend: The systematic assessment of a drug’s benefit-risk profile for the purpose of developing an integrated BR statement that helps in bringing a drug to the market and maintaining it there is a rather new challenge to the pharmaceutical industry triggered partially by a change in the format of periodic safety reports (PSUR) to Periodic Benefit-Risk Evaluation Reports (PBRER). Several methodologies for the development of such BR statements have been discussed and the choice of the "correct" one is not easy. A further challenge arises from the requirement to continuously re-assess the BR profile post-approval in an objective and transparent way. In this webinar we discuss ways to achieve a high-quality BR statement that satisfies the needs of regulators and aids patients and physicians in decision making about the use of a drug.
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Who Will Benefit: