Regulatory Roadmap. Module Section: Clinical

Описание: Phil Brown, Director, Regulatory & Compliance, is joined by Dr. Camilla Fleetcroft, VP Clinical & Regulatory Affairs at Eclevar UK to discuss clinical work.

02:32 What Does a Clinical Programme Look Like?
13:40 Relationship of Clinical & Classification
16:40 Equivalency
21:49 IVD Performance
30:11 Combination & Companion Products
34:39 The Clinical Protocol
38:31 The Role of the Regulator - National & International