Spring Intro 2023

There is global dis-harmonisation in handling changes

Minor change

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Major change

Data Requirements

Procedures

Implementation timeframe

Approval Timelines

Fees

The Organisation for Professionals in Regulatory Affairs

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Looking at any change:

● It is possible to form a scientific opinion on the extent/impact of the change ● It is possible to evaluate its effect on Q-S-E ● It is possible to prepare justification for the change ● It is NOT possible to have the same change approved in the same way, in every country worldwide ● It’s IMPOSSIBLE to have a change approved at the same time in every country ● Close correlation of regulatory CMC with supply chain is CRITICAL to plan changes and global implementation plans to prevent disruption to supply.

The Organisation for Professionals in Regulatory Affairs

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