Chronic clinical conditions are considered to be among the leading causes of death and disability globally. Typically, individuals are required to medicate on a daily, weekly and/or monthly basis. In addition to the cost of medication, patients are also burdened with a deteriorating quality of life. Now more than ever, patients are taking a more active role in their health and 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 not only for healthcare expenditure but also patients because of the inherent 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.
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.
Paul Scannell, Sr. Director, Regulatory Affairs, EU, West Pharmaceutical Services, Inc.
Paul Scannell leads the West regulatory activities related to medical device and combination products intended for European and Eurasian Economic Union (EAEU) territories and is the co-chair of Medicines for Europe Medical Devices Task Force. Prior to joining West, Paul was the Technical Regulatory Director within the Global Device Development Group at Viatris. Paul also served as a Senior Consultant (European medical device regulatory SME) with PAREXEL Consulting’s Integrated Product Development group and spent approximately 10 years as a medical device assessor within both the Health Products Regulatory Authority (HPRA) and National Standards Authority of Ireland (NSAI).
Adam Coblentz, Principal, Regulatory Affairs Intelligence, West Pharmaceutical Services, Inc.
Adam Coblentz is the Principal, Regulatory Affairs Intelligence professional for the Regulatory Affairs organization at West Pharmaceutical. He is responsible for executing global research and intelligence activities in support of West’s product portfolio. In this role, he leverages his almost two decades of experience to ensure West Pharmaceutical is on the leading edge of the latest global regulatory standards, guidance and best practices. Adam is on a variety of steering committees including Application of quality systems to medical devices, Application of risk management to medical devices and Vaporized hydrogen sterilization. Adam has a Bachelor of Science degree in Business Management from the University of Phoenix, is RAPS medical device certified and is a certified ISO 13485 Lead Auditor.
Who Should Attend?
- Regulatory Affairs
- Device Engineering
- Design Engineering
What You Will Learn
- Gain insight on the differences and similarities between the US and EU regulatory frameworks for co-packaged combination products
- Identify how device and drug manufacturers can work cohesively to address the regulatory requirements in both the US and EU markets
- 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
West Pharmaceutical Services
West Pharmaceutical Services, Inc. is a leading provider of innovative, high-quality injectable solutions and services. As a trusted partner to established and emerging drug developers, West helps ensure the safe, effective containment and delivery of life-saving and life-enhancing medicines for patients. With 10,000 team members across 50 sites worldwide, West helps support our customers by delivering approximately 47 billion components and devices each year.
2023 marks West’s 100-year milestone of innovation and the critical role it continues to play in healthcare and the patient experience. Headquartered in Exton, Pennsylvania, West in its fiscal year 2022 generated $2.89 billion in net sales. West is traded on the New York Stock Exchange (NYSE: WST) and is included on the Standard & Poor’s 500 index.