Drug/Device and Device/Drug Combinations in the EU and USA

BENEFITS OF ATTENDING
Understand the European Regulatory Guidance
Know what your Competent Authority expects
Gain an insight into Notified Bodies considerations on drug/device products
Learn how to define the approval route for your product
Clarify the major differences in documentation and approval routes
Consider quality systems requirements for combination products
Discover the FDAs Regulatory approach to combination products
Hear how to deal with Human Tissue Engineered products
Stay up-to-date on Post Market Surveillance for combinations products.

Development and regulatory personnel in the medical device, pharmaceutical and diagnostic industries, who are interested in medical devices incorporating ‘pharmaceutical’ ingredients, or pharmaceutical products incorporating a device or delivery system.

Introduction/Aim This seminar will focus on the EU regulations for drug/device and device/drug combination products including needle-free, pen and auto injectors in addition to other combination products. It will provide an excellent opportunity for delegates to understand the complex regulations and will assist in establishing the best regulatory route for their product to achieve success in the European market. Delegates will have the opportunity to send specific queries in advance of the event to ensure they are addressed at the seminar.