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Regulation of Combination Products and Other Technologies in the EU

The course will provide delegates with a sound understanding of the regulations applying to a range of medical technology products including drug-device combinations, in vitro diagnostics and advanced therapy products (especially tissue engineered products).

Delegates will learn to determine which regulatory framework applies and understand the principles of bringing products to market under the different frameworks.

The module will focus upon European requirements and will emphasize the requirements for ‘borderline’ products, especially drug-device combinations.

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09:00 – 17:00 (Time Zone Sensitive)
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