The 10th Annual FDA/ADVAMED Medical Devices and Diagnostics Statistical Issues Conference, taking place on April 26, 2017 to April 27, 2017, brings together leading authorities from FDA, industry, and academia to address statistical topics through two tracks – therapeutic device and diagnostics.
ACRP Clinical Researcher
ICH E6 R2 – Miracle Pill for the Clinical R&D Industry
Steve Young, Chief Operations Officer, CluePoints
Publication of the long-awaited ICH E6 (R2) Guideline this year finally makes it official. A risk-based approach to clinical trial quality management – commonly referred to as risk-based monitoring or RBM – is now a codified GCP expectation for the industry.