Module 16 2022

07/09/2022

Conclusions

• The exercise(s) is to gain a deeper understanding of the considerations to be made when determining whether or not an event is reportable or not, who should be notified and in what timeframe. • Guidance available does provide a good level of clarity of requirements but there is still room for ‘interpretation’. • Manufacturers should take a responsible approach to vigilance to help ensure safe patient/ user use of their products, to limit potential for litigation and a bad press, and help ensure the success of their business.

The Organisation for Professionals in Regulatory Affairs

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