Annex I of the Medicinal Products Directive 2001/83/EC has been amended on the basis of Art. 117 MDR. In the context of these new requirements, a number of questions and uncertainties arise regarding implementation, which we would like to address and discuss at our conference on combination products in the EU (in accordance with Art. 117 MDR), as well as highlighting solutions to existing problems and areas of tension.
This event will take place live and interactively on 11 and 12 November 2024. You have the opportunity and are cordially invited to ask questions and enter into dialogue with the speakers.
We have planned to focus on current topics:
- Combination products - legal anchoring and practical problems
- Article 117 - The devil is in the detail
- Combination products in the EU - collision of two worlds?
- Guideline for the authorisation of a product with a prefilled syringe in accordance with the EU MDR. Experiences and challenges
- Prefilled syringes - anyone can do them, right?
Get further information here (in German)