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

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

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.

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