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The West Blog
January 17, 2020
The Latest on Regulations: ICH Guideline to Manage Change throughout the Commercial Lifecycle of Drugs and Combination Products – Part 2
Part 1 of this two part blog series, gave a high-level overview of the new ICH guideline <em>Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management</em>. In part 2 of this blog series, some of the key takeaways will be discussed in more detail. <em>Q12</em> is intended to help companies demonstrate increased product and process knowledge, and understand which post-approval changes will require a regulatory submission, as well as the level of reporting for each category.