Development of Drug/Device and Device/Drug Combination Products 2018 is a conference dedicated to technical requirements of device design and pharmaceutical product development.
Development of Drug/Device and Device/Drug Combination Products 2018 covers topics such as:
- Different regulatory approaches in the EU and USA
- Definitions for drug/device and device/drug combination products in the EU and USA
- Biological and Synthetic Drug Regulation and its requirements
- Requirements for the Device Technical File / Design File
- Data required for the Common Technical Document n Consider the regulatory strategy depending on your product
- Registration procedures for devices and medicines in the EU and USA
Development of Drug/Device and Device/Drug Combination Products 2018 brings together:
- Development, regulatory and quality personnel involved in development of combination products (drug/device and device/drug products)
- Pharmacovigilance/vigilance personnel
- Device experts
