Development of Combination Products: Critical Interactions

Management Forum 19/11/2019 to 20/11/2019 | United Kingdom, Cavendish Hotel
+44 2077494730

Drug/device and device/drug combination products are becoming increasingly important in the medical industry. The development of these products raises a number of complex issues regarding the development process and their manufacture. The quality and regulatory aspects to consider are also challenging. This seminar will clarify the EU and US approach to drug/device and device/drug combination products. It will discuss the requirements for the Device Technical File/Design File and will explain the Biological and Synthetic Drug Regulation and the registration procedure for these products.

The programme will also cover the regulatory strategy to adopt for these products and the key aspects of GMP and quality processes applicable for drug/device and device/drug products, including the data expectations for the Common Technical Document.

Delegates will find this a comprehensive overview of the requirements for these drug/device and device/drug combination products and will have an opportunity to discuss the complexities with an expert in this field.

 

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