Recorded Webinar: Good Pharmacovigilance Practice - Inspection and Audits

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Webinar Duration: 90 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: Steve Jolley

This webinar will describe how to conduct a thorough drug safety and pharmacovigilance audit, including compliance with applicable worldwide laws, regulations and guidance. In addition, attendees will learn how to compare the company's pharmacovigilance operations to applicable best practices.

The course will cover all aspects of drug safety and pharmacovigilance compliance including the collection, assessment and reporting of adverse event cases, the analysis of cases to detect signals, the management of signals and safety concerns, and the development, execution and monitoring of risk management plans.

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

Steve Jolley is a subject matter expert in all areas of global safety compliance and signal detection, and is a frequent speaker at leading industry events including DIA and MHRA.
He has 25 years’ experience in drug safety & pharmacovigilance and has worked with over 50 clients in the US, Europe and Japan. He holds degrees in mathematics and computer science from Cambridge University, England. Steve is a featured speaker with FDA at DIA conferences and webinars on auditing, signaling and data mining.
Steve began his career in the pharmaceutical industry in 1985 when he founded DLB Systems, a supplier of computer systems for clinical trials and adverse event reporting to many of the leading life science companies worldwide. DLB was acquired by eResearch Technologies in 1997; since then Steve has worked as an independent consultant.
After your payment, we will contact you with instructions about how to access the webinar.