Navigating EU and FDA Regulations for Drug/Device and Device/Drug Combination Products

This course has been designed to provide regulatory affairs professionals with a deep understanding of the regulatory frameworks governing drug/device and device/drug combinations in the European Union and the USA.

The demarcation between medicinal products and devices is becoming ever more important and, with the convergence of emerging novel technologies, the number of drug/device combination products and medical devices incorporating a medicinal substance is increasing. At the same time, cell therapy and tissue-engineered products are being combined with both pharmaceuticals and medical devices. This course will address the European and FDA regulatory requirements, help you define the regulatory route for your product and offer practical guidance on Notified Body expectations, clinical trial considerations and post-market surveillance of borderline products.

Participants will have an invaluable opportunity to discuss the complex issues involved with key regulatory experts in this field.

By the end of the course participants will have the knowledge and skills needed to navigate the complex regulatory landscape for drug/device and device/drug combinations in the EU and the USA effectively. They will be equipped to ensure compliance with the regulatory requirements and facilitate the successful development and commercialisation of these innovative products. 

PRE-SEMINAR READING - It is recommended that you have read the the EU Medical Device Regulation, particularly, Article 120 and the General Safety & Performance Requirements (Annex I) and Technical Documentation (Annexes II and III). For the US, review FDA’s Office of Combination Products website prior to attending this seminar.