Drug Delivery — Addressing Global Regulatory Challenges in Co-Packaged, On-Body Systems

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.

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.

Speakers

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).

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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.

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