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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.
Combination products have gained additional interest recently with the US FDA continuing to evolve the regulatory space for this area, the upcoming implementation of EU MDR (Medical Device Regulation) and drug manufacturers expanding into additional regions. At the session of Combination Products - Part 2: Evolving Global Regulations: Health Authority Perspective, Lynn joined a panel of industry and agency leaders (FDA/CDER, Novartis, Pfizer, Johnson & Johnson, etc.) to provide perspectives on the dynamic combination product regulatory landscape.
Lynn presented the process of filing a combination product in China, including requests for classification and possible filing pathways. She also compared the China and US classifications and filing process for various delivery, safety and administrative systems. Ongoing initiatives for filing proprietary device information to support a combination product were explored as well.
The presentation was well received and a great opportunity for West’s regulatory team to share their expert perspectives on the latest regulatory development and strategies in combination products.
West strives to be at the forefront of regulation changes to better support our customers. Contact a Regulatory Affairs representative for more information.
The global prefilled syringe market is growing rapidly, and approximately 60% of prefilled syringes use staked needles. To help ensure the integrity of the drug products contained within, the majority of staked-needle prefilled syringes use Rigid Needle Shields (RNS).
Injectable drug products have stringent requirements for the presence of visible particles. However, there is currently no regulatory guidance for visible particles related to packaging components. Instead, specifications are established between suppliers and customers.
In 2004, Camp Victory, which is located in Millville, Pennsylvania, and operates camps for children who live with chronic health disadvantages including spina bifida, autism and cancer, added a wheel-chair friendly treehouse to their “Wish List” of needs. The tree house came with a hefty price tag and for several years, it sat on the list untouched. Just when Camp Victory was about to remove the treehouse from the wish list, it received a call from West’s CEO Don Morel and the campaign to build “Uncle Walt’s Treehouse” was born.
Designed to help improve consistency and reliability of intradermal inject.
In 2012, West rolled out a new global branding initiative that included a new tagline: By Your Side for a Healthier World<sup>TM</sup>. What does that mean? Every day, injectable drugs and vaccines are administered to improve the health of millions of patients around the world. And every day, West works by the side of its health care partners to design and manufacture drug packaging and delivery systems that will bring those drugs and vaccines from concept to the patient more efficiently, reliably and safely. This has been West’s legacy since the Company was founded in 1923.
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