Previous Blogs

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By Fran DeGrazio

June 21, 2021

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 over 20% of attendees were not aware of the considerations needed to build a control strategy.

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By Caitlin Joran

June 09, 2021

Earlier this year, we held a free 3-day virtual workshop (4 hours per day) bringing together industry experts and thought leaders in a unique forum to address a series of challenges and practical strategies to de-risk their injectable combination product development and commercialization.

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By Katie Casale

January 06, 2021

On November 6, 2020, West’s Regulatory Affairs Senior Director, Lynn Lundy, presented at the 2020 ISPE (International Society for Pharmaceutical Engineering) Annual Meeting and Expo. The week-long virtual meeting focused on steering the future of pharmaceutical science and manufacturing toward a more global, synchronized, and quality-driven industry. Pharmaceutical and biopharmaceutical professionals from drug manufacturing, supply chain, devices and equipment and services, and global regulatory agencies were in attendance to discuss hot topics such as Data Integrity, Covid-19 Impact, Combination Products and more.

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By Jen Riter

January 24, 2020

Combination products open up new vistas when it comes to delivering innovative therapies to patients in need, but teams bringing these products to the market face a number of significant hurdles. Recent surveys conducted by West at workshops held in PA and AZ revealed some of our customers’ biggest challenges. This is the final of our three blogs focused on these challenges — and how West can help Simplify the Journey™ when it comes to developing a combination product.

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By Fran DeGrazio

January 17, 2020

Part 1 of this two part blog series, gave a high-level overview of the new ICH guideline Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.  In part 2 of this blog series, some of the key takeaways will be discussed in more detail.  Q12 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.

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By Fran DeGrazio

January 14, 2020

ICH (International Council for Harmonization) recently adopted (1 Nov 2019) the guideline Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. This guideline includes two annexes and aims to “promote innovation and continued improvement in the pharmaceutical sector”.