Development of Drug/Device and Device/Drug Combination Products
What this course is about
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. The Biological and Synthetic Drug Regulation will be explained as will the registration procedure for these products.
The regulatory strategy to adopt for these products will be considered and the key aspects of GMP and quality processes applicable for drug/device and device/ drug products will also be covered, 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.
Benefits in attending
- Clarify the definitions for drug/device and device/drug combination products in the EU and USA
- Understand the different regulatory approaches in the EU and USA
- Consider the requirements for the Device Technical File/Design File
- Comply with the Biological and Synthetic Drug Regulation and its requirements
- Understand the registration procedures for devices and medicines in the EU and USA
- Determine the data required for the Common Technical Document n Consider the regulatory strategy depending on your product
Who should attend
All development, regulatory and quality personnel involved in development of combination products (drug/device and device/drug products). Pharmacovigilance/vigilance personnel will and this seminar beneficial. Also device experts looking to expand their knowledge to medicines and vice-versa.