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The environment for developing an injectable drug device combination product (CP) is dynamic from a regulatory and technical perspective. At the center of it all are the patients and their needs. West is pleased to announce the publication of its review manuscript that provides a detailed overview of best practices for this kind of development program. It considers technical and regulatory aspects and can be used as a foundational document for drug formulators, scientists and engineers working in this area.
Creating a holistic, well rounded approach that puts management of risks at the center of development will be critical to address key CP issues, including:
To learn more on this topic please click here to sign into our Knowledge Center to read the full article.
Awareness of the ever-changing technical and regulatory landscapes in the pharmaceutical industry is an essential element of West’s focus on the safe and efficient delivery of drug products. For more on how West can support CP development, contact an Account Manager or Technical Customer Service (TCS) representative.
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.
This is the first in a series of posts that will discuss the major issues that pharmaceutical manufacturers should consider when evaluating a packaging component supplier’s regulatory support.
On March 26, the Delaware Valley Chapter of PDA and West Pharmaceutical Services, Inc. co-sponsored a workshop: Defining a Strategy for Combination Products, at West’s headquarters in Exton, PA. More than 150 people from 45 companies that provide drug products and combination products attended. In prior PDA events, combination product regulatory challenges have been cited often as an area both of interest and confusion. This workshop aimed to address them.
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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