Drug-Device Combination Products and Article 117
Are the regulatory complexities of Drug-Device Combination Products overwhelming you?
This webinar will explore the latest advancements and insights regarding integral Combination Products that must be registered as drugs under the current legislation. We will delve into complex topics such as:
- Drug Device Combination Products and article 117
- How to apply for a Notified Body Opinion
- Data requirements to prove compliance with the relevant general safety and performance requirements (GSPR)
Agenda
00:00 – Introduction
05:31Â – Legal Basis
16:58Â – What is article 117
22:07Â – Guidance
25:21 – Manufacturers Obligations and Regulatory Issues
16:58Â – What is article 117
22:07Â – Guidance
25:21 – Manufacturers Obligations and Regulatory Issues
52:00Â – Q&A
Speaker
Salma Michor, PhD
Division Head Regulatory Affairs
Regulatory Affairs Pharma and Biotech
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