– 2.7, Product Information, responses to the Health Authority questions, clinical study protocols and reports, investigator’s brochures, case report forms, informed consent forms and other relevant
documentation (Study protocols and amendments, IB, Patient consent forms, case report forms, study manuals and study tools) Preparation of and participation in Scientific Advice Meetings with Health Authorities
receiving site, facilitate adequate project documentation, report and follow-up on project milestones, coordinate financial and resource requirements, mitigate risks and align the project team on the project
Assurance, Quality Control, Engineering, Validation, Manufacturing and Regulatory Affairs Review of protocols, batch records, specifications, reports, regulatory filings, SOP`s (Standard Operating Procedures
Modules 2.4 – 2.7, Product Information, responses to the Health Authority questions, clinical study protocols and reports, investigator’s brochures, case report forms, informed consent forms and other
approval of study documentation (Study protocols and amendments, IB, Patient consent forms, case report forms, study manuals and study tools) Preparation of and participation in Scientific Advice Meetings
, Business Leadership, Quality Assurance, Quality Control, Engineering, Validation, Manufacturing and Regulatory Affairs Review of protocols, batch records, specifications, reports, regulatory filings, SOP`s
receiving site, facilitate adequate project documentation, report and follow-up on project milestones, coordinate financial and resource requirements, mitigate risks and align the project team on the project