Regulatory Peculiarities |Coffee Break Life Sciences Start Ups #12

Combination Products and Companion Diagnostics

The regulatory pathways for medicinal products (drugs) on the one hand and medical devices / in-vitro-diagnostics on the other are different and separate from each other. When a medicinal product is meant to be used in combination with a medical device, or when a diagnostic test needs to be performed to support the choice of the right medication, special rules apply that impact your regulatory strategy from the beginning. Dr Manja Epping and Christoph Behm will guide you through typical scenarios and strategic options.

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