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.
Pharmacogenomics (PGx) Fact Sheet
Pharmacogenomics aims to develop rational means to optimize drug therapy with respect to the patient’s genotype, ensuring maximum drug efficiency…
Optimize drug therapy with respect to the patient’s genotype, ensuring maximum drug efficiency with minimal adverse effects.
Pharmacovigilance and its Place in the Industry
Pharmacovigilance ensures patients can trust the people handling their healthcare. Learn more about the importance of patient safety and what we’re…