Development of Combination Products: Critical Interactions
Drug/device and device/drug combination products are becoming increasingly important in the medical industry. The development and manufacture of these products raises a number of complex issues and the quality and regulatory aspects are challenging. This interactive seminar will clarify the EU and US approach to drug/device and device/drug combination products, address the requirements for the device technical file/design file, explain the biological and synthetic drug regulations and look at the registration procedures for these products.
The programme will cover the regulatory strategy to adopt and the relevant aspects of GMP and quality processes, including the data expectations for the CTD. It will also review the key relationships between quality, regulatory, R&D and production. Delegates will find this a comprehensive overview of the requirements for these products and will have an opportunity to discuss the complexities with an expert in this field.
Benefits of attending:
- Clarify the definitions for drug/device and device/drug combination products in the EU and USA
- Consider the requirements for the device technical file/design file
- Comply with the biological and synthetic drug regulations
- Understand the registration procedures for devices and medicines in the EU and USA
- Determine the data required for the Common Technical Document (CTD)
- Consider the regulatory strategy depending on your product
- Gain practical advice on how to apply the ISO standards
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Reviews by course attendees
Average rating 4.4
The speaker was very clear and enabled participants to ask questions with a lot of patience and with clear answers.
Overall content of the webinar was very good and covered a lot of topics.. The presentation was clear and included a lot of information. I believe this course was very informati...
I was hoping to achieve more knowledge about combination product and the regulatory documentations needed for the market authorisation and this was completely accomplished.