FORUM INSTITUT COURSE | Drug<-->Device Combination Products: Taking hurdles efficiently

FORUM INSTITUT COURSE | Drug<-->Device Combination Products: Taking hurdles efficiently

📆 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.

🔝 Use this link to register and benefit of a 10% discount on the course price:

https://www.forum-institut.de/seminar/2111273-drug-device-combination-products-taking-hurdles-efficiently/17/N/0/161850/def37fe

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