Local Representation: What Clinical Trial Sponsors Need to Know

Summary

In this white paper, best practices are described as well as required Sponsor/Local Representative agreement areas. It is important that major subject areas are agreed in order to ensure that the conduct of the clinical trial does not cause issues when the new drug application is assessed by the competent authorities. Although Local Representation applies to multiple areas of Pharmaceutical Development (Regulatory, Legal, etc.), this Whitepaper is limited to the area of Pharmacovigilance.