Die folgenden Informationen liegen ausschließlich in englischer Sprache vor.

A unique opportunity; learn how to navigate the regulatory roadmap for combination products.

To let patients benefit from your combination product, it is essential to develop in compliance with the applicable regulations from the beginning on. Medical devices and medicinal products each have their own set of regulations. For medical devices you need a CE certificate assigned by a notified body valid for all EU, whereas for a medicinal product, you need to gain marketing authorization from a NCA per country. And when you are looking to access the US market you encounter FDA regulation.

Sounds complicated? And what if my product is both?
Do not worry! In this webinar we will explain:

1.Why you need market approval
We will start by explaining the basic structure including the differences and similarities between CE marking and marketing authorization.

2.How do you determine which regulations are applicable to you as a manufacturer
Your device can never be a medical device AND a medicinal product. You need to choose which set of rules is applicable for your product. We will explain how to determine this.

3.What technical documentation you need
Once you have determined which rules are applicable, the rules prescribe which documents you need. We will give a short overview of the documentation required for medical devices and medicinal products.

4. Voyage to the new world
With an initial grasp of regulatory requirements in the EU and an idea of how to get started, we glimpse across the Atlantic to discuss how combination products are regulated by the FDA. We will explain entities involved and describe how you can approach them, where precedent can be found and what guidance is available to you.

At the end of this webinar, you know where to start with building the file for your drug device combination product.
 

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