Why should you attend: During high profile drug withdrawals of the past, most of the focus of the press and legal community was on the actual adverse event and the people who were injured. Today the attention seems to be on the documentation of how and when companies learned of the increased frequency of adverse events and what they did about it.

Meanwhile, international regulatory guidances on drug safety monitoring are increasing. With ICH E2E and E2C, CIOMS VI and VII, and the FDA Amendment Act, companies may need to audit their pre-marketing and post-marketing safety monitoring practices to ensure they are following Good Pharmacovigilance Practices.

A pharmacovigilance audit begins with a strong methodology that captures the key requirements of all the applicable regulatory bodies. It compares a company’s practices to an "ideal" process map that includes strategy, infrastructure, tools, execution and evaluation.

Areas Covered in the Session:
Regulatory Background: matrix of safety regulations; postmarketing safety reporting: CFR; International Conference on Harmonisation (ICH); ICH topic codes and reports; Council of International Organizations of Medical Sciences (CIOMS); Eudravigilance; Clinical Trials Directive; Volume 9a

The Pharmacovigilance Audit: overview of the pharmacovigilance audit; typical pharmacovigilance current process model; best practice approach to enhancing process model; achieving best practices through the pharmacovigilance assessment; value derived; scope; company sources of information to be examined; PV checklist; audit report table of contents; limited audit

Practical Tips: Importance of QPPV in Europe; need for oversight of the pharmacovigilance system; ensuring information on adverse events is accessible; suitability of people; requirements for SOPs; processing of ICSRs; electronic reporting; Periodic Safety Update Reports (PSURs); signal detection practical tips; quality assurance

Who Will Benefit:

• Drug safety and pharmacovigilance
  
• Regulatory Affairs
  
• Clinical development