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Are you challenged with managing change as it relates to a drug substance, drug product or drug/device combination product? You are not alone!
On December 3, 2020, West hosted a webinar that addressed this challenge by providing an overview of the ICH (International Council for Harmonization) Q12 guidance: Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. Speakers were:
The webinar polled the attendees with the question: What is the status of implementing lifecycle management for your new products as outlined in ICH Q12? The answers varied:
Clearly, the challenge of lifecycle management is a risk across the industry. Even though this is a regulatory expectation, the industry is struggling with how to address the issue.
The ICH Q12 guidance provides tools that help to facilitate both change and lifecycle management. The webinar provided a detailed example of how to utilize these tools. At its heart is leveraging the Quality by Design (QbD) concept in development. The greater the product and process understanding, the more effectively changes can be managed.
International guidelines such as ICH Q12 are being reinforced by the FDA and other regulatory agencies to encourage continuous improvement and accelerate innovation in the industry. For additional information you can access the full webinar OnDemand by clicking here.
ICH (International Council for Harmonization) recently adopted (1 Nov 2019) the guideline <em>Q12</em> <em>Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management</em>. This guideline includes two annexes and aims to “promote innovation and continued improvement in the pharmaceutical sector”.
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.
Do you want to better understand how to navigate the regulatory pathway to successfully bring a drug/device combination product (CP) to market? Understanding that many have this question, West, in collaboration with the Delaware Valley Chapter of PDA, sponsored the symposium (Sep 23): <em>The Evolving Landscape for Combination Products – Defining a Regulatory Strategy</em>. Experts from the industry and the FDA presented and discussed the latest best practices.
Fran DeGrazio is an industry leader with over 35 years of experience in technical product development, quality, regulatory, marketing, and business strategy. Prior to retirement in 2022, DeGrazio was West Pharmaceutical Services’ Chief Scientific Officer and led a legacy of innovation through Quality by Design (QbD) and leading patient-centric elastomer components. Before her retirement I had the opportunity to discuss the development of 4040/40 gray formulation as the newest addition to West’s quality by design program the formula journey, the evolution and its importance in the marketplace.
There are clear gaps in understanding in the market of combination products. A major one was highlighted at a recent workshop sponsored by West. A survey showed that <em>over 20% of attendees were not aware of the considerations needed to build a control strategy. </em>
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