Webinar - Safety and Performance Based Pathway Criteria
Target Audiences: Industry (medical device companies or distributors, technology manufacturers (including start-up companies or labs), academic and research institutions, healthcare facilities, professional societies, foundations and other non-profits.
The use of well-developed patient-reported outcome (PRO) instruments helps to accomplish capture patient voice during the design and evaluation of medical devices in a structured, well-defined, and reliable way.
EMA published regulatory and procedural guideline: Guidance on remote GCP inspections during the COVID-19 pandemic The guidance covers all phases of remote GCP inspections, with a particular focus on the more challenging aspects, such inspection initiation, feasibility assessment and preparation.