Development of Combination Products: Critical Interactions

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.

Topics

• 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

Who should Attend

• 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