Short Abstract

Pharmaceutical products need effective benefit- risk management and regular benefit-risk assessments are required for periodic safety reports ( PSUR, PBRERs, DSURS ) and also for new submissions, licence renewals. Companies have their choice to decide about the benefit-risk evaluation method they prefer for their products depending on the phase of clinical development or life cycle management of the individual drugs. The format of a benefit-risk assessment document is also at the discretion of the individual companies and no standard regulatory or ICH template is available yet.

In this session we talk about the relationship between risk management plans and effective benefit risk management in reference to an internal document called Integrated Benefit Risks Assessment ( IBRA). This internal stand alone document is a helpful tool to discuss the benefit-risk profile of drugs and can serve as a source document for different regulatory purposes. Through a case study we describe the process of the development of the IBRA, its structure and relationship to risk management plans. We present a simple, pragmatic, tailor made qualitative benefit risk analyses tool called the cardinal trait method which we developed for a class of well established oncology products.

This technique is believed to be applicable for the vast majority of drugs and offers a straightforward, pragmatic approach which is rooted in the new concept of effective patient risk management.

The presentation will cover the following areas:

• Effective benefit risk management- a new concept based on the patient risk management plans
• Regulatory documents and benefit –risk assessment. Requirements and current practice
• The structure of the integrated benefit risk assessment- IBRA
• The use of patient risk management plan in the development of IBRA
• The cardinal trait method- hypothesis, strength and weaknesses. A case study.