Optimisation of Safety Data Collection

This guidance is being distributed for comment purposes only

This Guideline is intended to provide internationally harmonised guidance on when it would be appropriate to use a selective approach to safety data collection in some late-stage pre-marketing or post-marketing studies, and how such an approach would be implemented. By collecting selective safety data, the burden to patients would be reduced, a larger number of informative clinical studies could be carried out with greater efficiency, studies could be conducted with greater global participation, and the public health would be better served.

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