Join West on February 4, 2020 for an Educational Series in Paris, France
Join West industry experts to gain insight pertinent to getting your drug products to market in an efficient and effective manner. This program will deliver expert knowledge to help you understand and execute a risked-based critical thinking approach related to injectable drug packaging and delivery.
13 Rue Nungesser et Colii,
75016 Paris, France
12:30 - 13:00 Registration/Light Lunch
13:00 - 13:15 Welcome Dr. Janina Lehmann – Sr. Director Technical Customer Support NA & Europe
13:15 –14:15 Navigating the regulatory landscape for Drug Delivery – with focus on the new EU MDR and US regulations Dr. Bettine Boltres – Principal Scientific Affairs, Packaging & Delivery Systems EU
As baseline quality requirements, biologic drugs must meet the pharmaceutical quality standards as described in pharmacopeias and prove to be safe for the intended purpose of use. Beyond that, regulatory agencies are increasingly focusing on quality risk management in development, manufacturing and post-approval changes of sterile drug products and injectable devices. Pharmaceutical companies can benefit from employing an outsourced partner understanding the primary packaging, device, analytical and regulatory requirements along the drug development process and providing integrated solutions.
14:15 – 15:15The Impact of Yesterday’s Packaging Components on Manufacturing and Product
Quality of Today’s Drug Products and Tomorrow’s Novel Applications Dr. Björn Henze, Manager Technical Customer Support Europe
The sensitivities of biologic drugs demand greater quality in packaging systems in order to mitigate risks associated with the various packaging components. Legacy packaging components may no longer fit the requirements needed to ensure product safety and efficacy of these complex drugs throughout the shelf life. Containment and delivery systems must exhibit the required chemical, physical and performance properties to ensure product quality, be compatible with fill and finish processing equipment and provide necessary functional performance during administration.
15:15 – 15:45Break and Experience West’s New Product Innovations
15:45 – 16:45 CSTD impact on Container Closure Systems Dr. Janina Lehmann – Sr. Director Technical Customer Support NA & Europe Closed system transfer devices (CSTD) are a supplemental engineering control designed to reduce occupational exposure of hazardous drugs and are currently implemented in accordance with evolving regulations. As the CSTD landscape continues to develop, drug product compatibility and device performance testing should be performed. Learn how to mitigate the risk of drug product incompatibility with CSTD.
16:45 – 17:15 Interactive Discussion
Opportunity for further informal discussions with West experts and various colleagues from the pharmaceutical industry.