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.
PV Nugget #7 Pharmacogenomics
Pharmacogenomics (PGx) focuses on how genes and biomarkers can affect how an individual respond to drugs. The goal of PGx is to develop effective,…
Pharmacovigilance & Patient Safety
Clinical trial participants help us speed breakthroughs in modern drug development. Our job is to protect them.
Patient Safety and Pharmacovigilance Agreements
Pharmacovigilance Agreements (PVAs) are agreements between two companies based on their Commercial Agreements that require an exchange of safety…