Introduction to the EU Medical Device Regulation for combination products

- for Pharma professionals

Who should attend

This course is for you with regulatory knowledge within Pharma and a need for a better understanding of medical devices and the requirements introduced by the new European regulation, MDR.

You are active in, for example, regulatory affairs, quality assurance or compliance for medicines that are administered by means of a medical device.

Learning objectives

Knowledge about and clarification of the interaction between current legal requirements for medicines and medical devices. The purpose of the training is to ensure regulatory compliance for combination products.

Course details

• Introduction to MDR
• Article 117 – What is a combination product?
• Product requirements
• Notified body and economic actors
• Quality management system for medical devices – bridging to ICHQ10, what to expect of your supplier
• Time frame for implementation of MDR

Instructors

Belma Hot, Academy Leader & Consultant, Quality & Regulatory Affairs, MedTech & IVD
Leonardo Dahn, Teamleader & consultant  

The course is arranged together with PlantVision

Time and venue

The course is held online in virtual meeting room Zoom, October 25. 
More information coming soon.

Participation fee and registration

The registration fee is 7.100 SEK until October 6 and thereafter 8.200 SEK. The fee includes digital documentation and certificate in digital format.

All prices exclude VAT.

Other information

For information such as cancellation policy, participant list, GDPR – see “Registration Terms” to the right.