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The Post-Approval Challenge of Global Regulatory Complexity

 
• By Bowman Cox

Why industry wants Q12 lifecycle management guideline: 100 regulatory submissions for one post-approval change and other frustrations.

Industry representatives shared insights recently on the challenges of global regulatory complexity, as well as their visions of how these challenges could be overcome.

Their remarks at conferences earlier this month shed light on the hopes and frustrations that led pharmaceutical manufacturers to press the International Conference on Harmonization to craft a Q12 guideline...

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