Reasons to attend
This course will guide you through the complexity of developing drug-device combination products and provide you with useful tips and resources to navigate this evolving and exciting area where drugs meet devices, from product definition until clinical development.
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
- This course has been granted PharmaTrain Recognition
2 webinar sessions
Drug-device combination (DDC) products are seen as complex products and are regulated differently around the world. In Europe, the entry into the application of the Medical Device Regulation (MDR) in May 2021 changed the landscape of the development of these products. You will understand that behind the complexity of an evolving landscape, it is an exciting opportunity to develop products that meet patients’ expectations. While developing DDCs, you will have to understand the basics of drug and device regulations, guidelines, and specific definitions, to properly plan their development. What are the differences between pure devices, pure drugs, and combinations thereof? Where to start? What is the regulatory pathway? How to combine all requirements into DDC development?
This training will provide you with an overview of the regulatory frameworks underlying the DDC development, with a focus on Europe but also covering the differences with the USA. You will get useful tips and resources to navigate this continuously evolving area where technologies converge, define your product, optimize your quality system, and plan your DDC product development. This webinar will improve your understanding of DDCs, their classification, drug and device regulations and guidelines, and notified body and competent authorities’ involvement throughout the development.