Development of Combination Products: Critical Interactions is a conference dedicated to the requirements for drug/device and device/drug combination products in the EU and USA.
Development of Combination Products: Critical Interactions covers topics such as:
- Different regulatory approaches in the EU and USA
- The definitions for combination products in the EU and USA
- The Biological and Synthetic Drug Regulation and its requirements
- The requirements for the Device Technical File/Design File
- Data required for the Common Technical Document
- Registration procedures for devices and medicines in the EU and USA
Development of Combination Products: Critical Interactions brings together:
- Pharmacovigilance/vigilance personnel
- Development, regulatory and quality personnel involved in development of combination products (drug/device and device/drug products)
- Device experts looking to expand their knowledge to medicines and vice-versa
Development of Combination Products: Critical Interactions will be held on 12-13 Feb 2024.