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Many of our sponsor companies have not had previous experience of European Union requirements for clinical trials or commercial products, in this session we will discuss the requirements of Qualified Person audits.
- What needs to be audited for clinical and commercial supply chains?
- When the audits should be conducted to minimize impacts on timings for submissions.
- What the auditees can expect from the audit process?
- What the outcomes from the audit process are: Reports, QP Declarations, API Declarations
- How we work with the sponsor if deficiencies are observed during the audit process.
This session is ideal for any companies planning their first EU clinical trials or commercial product launches, or for any of those wishing to refresh on the requirements of EU Qualified Person audits.