The Complete Pharmacovigilance Audit Process: What to Expect
Understanding the Pharmacovigilance Audit Process The Pharmacovigilance Audit Process is an independent, objective assurance activity designed to add value and improve an organization’s safety operations. Whether it is an internal audit or a partner audit, understanding the scope is vital for compliance. The Scope of a PV Audit A standard Pharmacovigilance Audit Process evaluates […]
DSUR Drafting and Submission Challenges : Best Practices for Clinical Trials for the US, EU & UK
The Strategic Importance of DSUR Drafting and Submission Challenges : Best Practices for Clinical Trials for the US, EU & UK The DSUR Drafting and Submission process is the cornerstone of safety reporting during the clinical trial phase. An annual Developmental Safety Update Report (DSUR) ensures that regulators are kept informed of the evolving risk-benefit […]
PSUR and PBRER Drafting: GPLACO Drug Safety and PV Consulting services on Aggregate Safety Reports
PSUR and PBRER Drafting: GPLACO Drug Safety and PV Consulting services on Aggregate Safety Reports for Global Markets: US, EU & UK Effective PSUR and PBRER Drafting is essential for maintaining a product’s marketing authorization. These aggregate reports provide a high-level medical analysis of the drug’s safety and efficacy. Common Challenges in Aggregate Reporting: Data […]