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Online Live Training Features

All sessions of this unique course online

Live interaction options between the delegates and trainer

Available via mobile, tablet or laptop

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Meet the training leader

  • Sue Rees
  • Pharmacovigilance Expert, Former EU QPPV
  • United Kingdom
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Course description

Pharmacovigilance has undergone rapid regulatory change in recent years, which has resulted in a complex environment for pharmaceutical companies to operate. This course will provide a comprehensive, yet practical guide to pharmacovigilance audits and inspections best practice to help navigate what is required to demonstrate compliance.

Key takeaways

Learn how to prepare for a PV audit or inspection

Understand the legislation underpinning audit and inspections

Discuss real life scenarios and case studies

Explore the global environment

Get expert insights

Training audience

This Training Course is of particular interest to:

QPPVs

Pharmacovigilance staff in all disciplines

Quality Assurance and Compliance staf

Key topics

Inspectional updates from FDA, EMA & MHRA – examples of findings during inspections, changing pattern of inspection findings, current regulatory expectations

Remote audits and inspections – considerations, risks and mitigations; Inspection experience at time of Covid

Inspectors’ expectations regarding safety governance in patient support programs

Ancillary Departments role in audits and inspections: Call Centers, Med Info, Sales, Marketing Research, Product Complaints, Regulatory Affairs

Audit Reports and corrective and preventative actions

Ticket

Online Live Stream

from 1396 € Buy

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