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In October 2017, PDA (Parenteral Drug Association), held a joint workshop with PQRI (Product Quality Research Institute) entitled: Container Closure, Devices and Delivery Systems: Compatibility and Material Safety Workshop.
Industry and regulatory experts addressed best practices and obtained fresh technical information in order to bring clarity and direction around the risks and challenges of packaging and delivery systems – with an ultimate focus on combination products. Key points addressed included particulates, biocompatibility, leachables/extractables, biologic stability, and container closure integrity. The meeting opened with a plenary session, The Future of Drug Delivery by Didier Pertuy, Vice President and Global Head of Drug Device Integrated Development and Device Strategy, Sanofi. Other sessions were:
A summary can be found here.
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 have revealed some of our customers’ biggest challenges. This is the second of three blogs focused on these challenges — and how West can help Simplify the Journey™ when it comes to developing a combination product.
One of the increasing trends in the world of drug-device combination products is the use of platforms for drug families, delivery device technologies, and primary packaging.
Join West’s Graham Reynolds as he presents the keynote at Pharmapack North America. Graham will present, “<em><strong>Understanding the regulations and safety concerns surrounding injectables to overcome inherent design challenges” </strong>on </em>Wednesday, May 23, 2012 at 1:50 pm. The conference will be held at the Pennsylvania Convention Center, Philadelphia, PA on May 22-23.
On September 7th, 2023, a long-awaited final guidance was issued by the Food and Drug Administration (FDA) - Application of Human Factors Engineering Principles for Combination Products: Questions and Answers. The document is intended to be used in conjunction with other human factors related guidance and available national and international standards, such as AAMI HE75 and IEC 62366. In this latest guidance, the agency provides its view on best practices for conducting human factors activities for combination products either comprised of a device and a drug or a device and biologic.
Diane Paskiet will speak at the U.S. Pharmcopeial Convention’s “Suitability and Compatibility for Packaging and Delivery Systems: Extractables and Leachables” Conference, which will be held at USP Headquarters in Rockville, Maryland, on December 9-10, 2013.
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