📆 9- 10 November, 2021
💻 Online course
ASPHALION expert Dr Dominique Monferrer, together with other four excellent lecturers will share their in-depth knowledge with you and will address the new regulatory framework for drug-device combination products, the impact they will have on our products and how to implement the requirements.
The online training course will cover the following topics:
· Current and future regulatory framework
· Submission and quality requirements
· Article 117 MDR and its impact on drug-device combination (DDCs) products
· Clinical considerations and vigilance obligations
· Digital health and DDCs in the light of the new MDR
AIMS AND OBJECTIVES:
The regulatory requirements in the drug and medical-device sector pose numerous challenges to your products. Especially the Article 117 MDR and the draft guideline on quality requirements for DDCs will impact the industry regarding regulatory and quality-related issues, among others.