Blogs
Medical Devices USA/Europe Regulatory…
EUROPE
1. First references of harmonised European standards in support of Regulation (EU) 2017/745…
ICH E6 Good Clinical Practice Principles
The ICH E6 Good Clinical Practice (GCP) Guideline is widely used by clinical trial researchers b…
TGA’s Reclassification of Medic…
The New Reclassification system for medical devices is round the corner to its effective date (25 Nov…
Clinical Outcome Assessments (COAs) i…
A clinical outcome assessment (COA) describes or reflects how a person feels, functions, or survives …
Serotonergic Anti-depressants for Dep…
New Zealand’s Medicines and Medical Devices Safety Authority (MEDSAFE) has published few takeaways pe…
Clinical Trial Management Guidelines …
Good Clinical Practice (GCP) is referred to an internationally acclaimed ethical and scientific quali…
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