Introduction to European Good Pharmacovigilance Practices: 4-hr Virtual Seminar

This webinar is intended for the pharmaceutical industry and associated service providers. It will provide a robust introduction to Good Pharmacovigilance Practice (GVP) in the European Economic Area, reviewing all modules of the Guidelines on GVP published by the European Medicines Agency.

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Last Recorded Date: Nov-2021

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Downloadable link along with the materials will be emailed within 2 business days
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Why Should You Attend:

The introduction of Good Pharmacovigilance Practices in Europe had a substantial impact on the conduct of pharmacovigilance activities worldwide, setting a new ‘gold standard’ for pharmacovigilance. It impacts activities conducted by departments, affiliates, service providers, distributors, etc. not only in Europe but across the globe. This webinar will provide a robust introduction to all modules of GVP, enabling the audience to understand the impact of the GVP modules throughout the pharmacovigilance landscape.

The Guidelines on Good Pharmacovigilance Practices cover a wide range of topics in extensive detail, ranging from the quality systems that should support a pharmacovigilance system to the details of the pharmacovigilance system itself. Requirements apply from the date a potential marketing authorization holder applies for a marketing authorization anywhere in the European Economic Area, and also apply to all service providers providing pharmacovigilance support to a marketing authorization holder. European regulatory agencies have robust inspection GVP programs that use these Guidelines as the standard against which they inspect, with significant penalties potentially applied to marketing authorization holders found to be non-compliant.

Areas Covered in the Webinar:
  • European Guidelines on Good Pharmacovigilance Practices: Modules I through XVI
  • Practical implementation of GVP in pharmacovigilance and quality systems
  • Tips and hints based on practice experience
Who Will Benefit:
  • Global and European Pharmacovigilance departments
  • Quality assurance departments responsible for managing procedures, process deviations, audits and personnel training
  • Regulatory departments
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.

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