The Benefits of Automating Your Requirements Traceability Matrix
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ICH Q12 Implementation: Enhancing PACM Agility
Nov 30, 2023 2:12:33 PM | Explore the key aspects of ICH Q12 and a 5-step structured framework for effective post-approval change management (PACM) agility.
Posts about Post-approval Changes:
ICH Q12 Implementation: Enhancing PACM Agility
Explore the key aspects of ICH Q12 and a 5-step structured framework for effective post-approval change management (PACM) agility.
How Can You Simplify Regulatory Approval for PAC?
Learn how to simplify regulatory approval for post-approval changes and discover the benefits of implementing a PACM protocol and using a QRM platform.
Comparability for Post-Approval Changes
Today we want to take a fresh look into comparability for post-approval changes. How? We're thinking of a unique multiparametric approach.
Developing a Retrospective QbD: a ValGenesis Story
A story about this time we helped a company in the Post-Approval Change Management of a Legacy Product using a Retrospective QbD methodology.
Benefit-Risk Assessment for Drug Products
An important, and sometimes challenging, step in every product lifecycle is the point when it gets its premarket or a postmarket regulatory approval by the FDA. Luckily, through a combination of good practices for Benefit-Risk Assessment and technology, this has become much easier.
Creating a Post-approval Change Management (PACM) Protocol
In this blog post, we will give you all the steps about how to create a PACM protocol and how ICH Q12 supports you in it.
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