In this free webinar, learn about the differences and similarities between the US and EU regulatory frameworks for co-packaged combination products. Attendees will identify how device and drug manufacturers can work cohesively to address the regulatory requirements in both the US and EU markets. The featured speakers will share best practices to provide objective evidence to satisfy both US and EU requirements, limit duplication of efforts as well and avoid non-compliance to regional unique requirements.
TORONTO, May 25, 2023 /PRNewswire-PRWeb/ -- Chronic clinical conditions are among the leading causes of death and disability globally. Typically, individuals are required to medicate on a daily, weekly and/or monthly basis. Now more than ever, patients want to make treatment a smaller part of their life. The development and commercialization of self-administrable medicinal products outside a clinic, hospital or healthcare provider environment, is an attractive alternative for healthcare expenditure and patients because of the flexibility and desire to reduce clinic visits. As the number of patients suffering from such disorders increase, so does the demand for more convenient and patient-friendly drug delivery systems.
Over the past five years, significant improvements have been made to address dose volumes and treatment options, such as monoclonal antibody-based therapies. These treatments often have viscous, highly concentrated drug formulations that require higher doses and delivery volumes that are typically outside the range of standard syringe capabilities. Novel drug delivery technologies are being introduced, specifically, large volume, on-body drug delivery systems. The novelty of these solutions has increased the complexity of regulations and particularly how to navigate the regulations from a global perspective.
Currently, the majority of large volume wearable injectors are primarily present in North America and Europe, within which the principal global regulatory frameworks are led by, or based on, the United States and European regulations. These large-volume on-body delivery systems are typically co-packaged with pre-filled drug cartridges i.e., co-packaged combination products.
However, the pathway to approval differs between the US and Europe which can lead to diverse, complex regulatory strategies when developing a product that must meet both regulatory frameworks.
Register to learn about on-body drug delivery systems and addressing their complex global regulatory requirements.
Join experts from West Pharmaceutical Services, Inc., Paul Scannell, Director Regulatory Affairs Combination Products, EU; and Adam Coblentz, Principal, Regulatory Affairs Intelligence, for the live webinar on Thursday, June 15, 2023, at 10am EDT (4pm CEST/EU-Central).
For more information, or to register for this event, visit Drug Delivery — Addressing Global Regulatory Challenges in Co-Packaged, On-Body Systems.
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Contact:
Vera Kovacevic
Tel: +1 (416) 977-6555 x371
Email: [email protected]
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Vera Kovacevic, Xtalks, +1 (416) 977-6555 x371, [email protected]
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