In formulating its proposals the working group developed, reviewed and made use of actual case histories taken from the experience of companies and regulators in several countries. These examples were used to illustrate basic principles and methodologies as well as to suggest ways of displaying data in connection with benefit estimation, risk estimation and benefit-risk evaluation.

Guidance on the decision-making process and the use of outside experts was supported by information from a survey of regulators and companies in which details of recent significant safety issues and the decision-making process were requested.

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