FORUM INSTITUT- DDC Products: Taking hurdles efficiently

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.

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.
October 15, 2021

📆 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.

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