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Drug/device combination products present unique challenges. The current pandemic has highlighted the need for the regulation and discussion between authorities and industry.
A combination product is a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product.
This webinar will provide:
- a comprehensive understanding of a Combination Product system
- an overview of Global regulatory pathways (with the focus on FDA and European regulatory guidance)
- Overview of Combination Product submissions in USA & Europe
- Discussion about Combination product safety – Industry perspective
Participants will have an invaluable opportunity to discuss the complex issues involved with key regulatory experts in this field.
