RA intern tasks proposal

Handle renewal registration submission under guidance from senior staff

Handle IFU change notification filling under guidance from senior staff

Retrospective review on historical RA dossier archive per quality control check list form (the current RA archive are not complete. We have problems to access historical submission and approval records. There is no quality control or review on RA archive after each project closed or critical millstone passed

Summarize the historical requirements from acceptance deficiency letter and technical review deficiency letter within 3 years to create China regulatory self-inspection checklist to improve quality of technical documents submitted (there are similar defects repeated cross projects, the checklist would help to generate high quality technical documents template and provide review RA comments at early stage to avoid re-work)

Work on submission and approval performance matrix, collect and verify the matrix data cross RA dossier archive documents.(lack of historical data to evaluate NMPA approval relevant lead time)