Scheduling and Conduct of Good Pharmacovigilance Practice Audits

This webinar is intended for the pharmaceutical industry and associated service providers. It will provide pharmacovigilance and quality assurance departments with an overview of regulatory requirements and expectations for Good Pharmacovigilance Practice audit programmes, with a focus on auditing of activities internal to an organisation as well as those contracted out to service providers and commercial partners, such as distributors and licence partners.

Purchase using Webinar All-Access Pass
One User Unlimited access to all recorded webinars for 6 Months

Recorded Version Only

(PPT + Recorded Streaming Link)

1x Person - Unlimited viewing for 6 Months (For multiple locations contact Customer Care)
rec Recorded Link and Ref. material will be available in My Account Section
Last Recorded Date: May-2020

Download File Only

(PPT + Recorded Training File)

Downloadable file is for usage in one location only.
(For multiple locations contact Customer Care)
Downloadable link along with the materials will be emailed within 2 business days
Customer Care

Fax: +1-650-362-2367


Follow us:
Why Should You Attend:

The introduction of Good Pharmacovigilance Practices in Europe emphasized the need for the pharmaceutical industry to have robust auditing of their pharmacovigilance systems across their audit universe, i.e. activities conducted by global departments, affiliates, service providers, distributors, etc. Subsequent inspections by European regulatory agencies had and continue to have frequent critical and major findings relating to audit practices, showing the need for the industry to continue to develop this area. This webinar will consider regulatory obligations and discuss practical implementation of the audit lifecycle, from risk assessment to scheduling to conduct of audits.

Module IV of European Guideline on Good Pharmacovigilance Practices takes basic auditing principles and describes their application to the pharmacovigilance environment. Whilst the application legislation originates in Europe, the requirement is for a global audit programme that considers all activities and all stakeholders resulting in a resource-intensive and complex activity. All pharmaceutical companies and service provides must ensure they have an audit programme in place that meets agency expectations. The programme should be risk-based, ensuring that areas of high risk are identified and targeted. Finally, the audit programme should not only meet regulatory requirements, but also help the organisation in identifying areas of weakness and supporting the continued evolution of the pharmacovigilance system.

Areas Covered in the Webinar:
  • European Guideline on Good Pharmacovigilance Practices: Modules I and IV
  • Risk assessment of pharmacovigilance systems
  • Scheduling of pharmacovigilance audits
  • Conduct of pharmacovigilance audits – global departments, affiliates, service providers and commercial partners
Who Will Benefit:
  • Quality assurance departments
  • Pharmacovigilance departments
  • Pharmacovigilance auditors
Free Materials:
  • Reference documents
  • Rule documents or guidance
  • Checklist
  • SOP template
  • Easy fill in forms
  • Articles
Instructor Profile:
Miranda Dollen Miranda Dollen

Independent Pharmacovigilance Consultant, MZD Consulting

Miranda Dollen has over 25 years’ experience in pharmacovigilance. She began her career at the UK regulatory agency in the pharmacovigilance business unit, before spending 7 years in the UK pharmaceutical industry. In 2004 Miranda moved to the service provider side of the business, spending 14 years at CanReg, acquired by Optum, acquired by Mapi and latterly acquired by ICON. During that time she worked with multiple organisations as a European Qualified Person for Pharmacovigilance, led the European team and spent the last 4 years of her time with ICON as Vice President, Pharmacovigilance, responsible for global pharmacovigilance activities. Since 2018 Miranda has provided independent consultancy services to the pharmaceutical industry. During her career Miranda has worked with multiple Quality Assurance departments to develop and maintain a pharmacovigilance audit programme, as well as personally conducting pharmacovigilance audits.

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email call +1-888-771-6965 (Toll Free).

Product Reviews

This product hasn't received any reviews yet. Be the first to review this product! Write review

You Recently Viewed