Overview: This webinar will describe how to conduct a thorough drug safety and pharmacovigilance audit, like compliance with relevant worldwide laws, rules and guidance. In addition, attendees will discover how to compare the company’s pharmacovigilance operations to relevant greatest practices.

The course will cover all elements of drug safety and pharmacovigilance compliance including the collection, evaluation and reporting of adverse event instances, the analysis of instances to detect signals, the management of signals and security issues, and the growth, execution and monitoring of threat management options.

Why need to you attend: In the course of large profile drug withdrawals of the past, most of the emphasis of the press and legal community was on the actual adverse occasion and the individuals who had been injured. Nowadays the attention looks to be on the documentation of how and when organizations learned of the improved frequency of adverse events and what they did about it.

Meanwhile, worldwide regulatory guidances on drug security monitoring are increasing. With ICH E2E and E2C, CIOMS VI and VII, and the FDA Amendment Act, companies might need to audit their pre-advertising and publish-advertising safety monitoring practices to guarantee they are subsequent Great Pharmacovigilance Practices.

A pharmacovigilance audit commences with a powerful methodology that captures the key demands of all the applicable regulatory bodies. It compares a company’s practices to an “ideal” process map that consists of method, infrastructure, equipment, execution and evaluation.

Regions Covered in the Session:Regulatory Background: matrix of security laws; postmarketing safety reporting: CFR; Global Conference on Harmonisation (ICH); ICH theme codes and reports; Council of Global Organizations of Health-related Sciences (CIOMS); Eudravigilance; Clinical Trials Directive; Volume 9a

The Pharmacovigilance Audit: overview of the pharmacovigilance audit; typical pharmacovigilance latest procedure design; finest practice method to enhancing method model; attaining best practices by means of the pharmacovigilance assessment; worth derived; scope; business resources of information to be examined; PV checklist; audit report table of contents; constrained audit

Useful Suggestions: Value of QPPV in Europe; will need for oversight of the pharmacovigilance technique; guaranteeing data on adverse activities is available; suitability of people; requirements for SOPs; processing of ICSRs; electronic reporting; Periodic Security Update Reviews (PSURs); signal detection sensible ideas; high quality assurance. application audit