Regulatory considerations for product development and lifecycle management in the EU
This seminar is aimed at specialists and managers in the pharmaceutical and medical-device industries. Employees dealing with borderline issues in the areas of approval, certification, clinical/medical affairs, quality assurance and vigilance, can benefit greatly from this seminar.
This conference addresses the new regulatory framework for drug-device combination products. Use this opportunity to discuss the impact these changes will have on your products and how to implement the requirements.
The regulatory requirements in the drug- and medical-device sector pose numerous challenges to your products. Especially the new Article 117 MDR and the draft guideline on quality requirements for DDCs will impact the industry regarding regulatory and quality-related issues, among others.
After attending this training course, you will
- be able to classify your product in the correct product group
- know the consequences of current case law for the development, approval and post-marketing surveillance of your product,
- know the impact of Article 117 MDR and
- discuss the new quality requirement for DDCs.