Module 9 2021

16/03/2021

Specific Module 3 Components (cont.)

Module 3.2.R (cont.) ● Content evolving in other regions globally – Some have no specific requirements – Some manage regional requirements in Module 1 – Some adopt partial EU or US requirements or their own specific requirements

The Organisation for Professionals in Regulatory Affairs

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Practical Considerations

• Too often Module 3 finalisation is rushed and becomes inconsistent • Ensure that Regulatory schedules time in the review prior to filing to read through the entire Module 3 end to end • Try to ensure that data is not repeated in multiple sections wherever possible • This impacts not only the quality of the Module 3 but can have significant lifecycle repercussions ● Could be as simple as “what can we consider registered for this parameter when it is stated in a different way in Module 3.2.X & 3.2.Y?” • The power of flexible wording such as “typically”/“or equivalent”/”or validated equivalent”

The Organisation for Professionals in Regulatory Affairs

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