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Drug Information Association

How to Prepare for Pharmacovigilance Audits and Inspections

Practical Information

Commencing Date:
tba
Language:
English
Location:
Berlin Germany


Teaching Methodology:
Face-to-Face


Scholarship Possibilities:
No

Course Contact

Drug Information Association

University Accreditation: No

Individual Course

Description

Every pharmacovigilance function will, at one time or another, undergo governmental or health authority inspections as well as audits by license partners, internal auditors and others. The course will teach you how to prepare for an audit / inspection from the time of the receipt of the announcement (or of the arrival of the inspectors at your doorstep) to the conclusion of the audit or inspection.

Outcomes

At the conclusion of this course, participants should be able to: - Participate in audits / inspections and mock audits / inspections - Assess how to handle the actual audit / inspection and responses to requests and findings based on the understanding of audit / inspection methodology the legal basis of inspections or the contractual basis of audits and the appreciation of regional differences - Prepare responses to audit / inspection findings, including responses and corrective/ preventive action (CAPA) plans - Prepare their function for an audit / inspection: roadmap, teams, tasks, and documents - Assess regional differences with respect to European and US FDA inspections

IMI Standards

  • A predefined set of teaching objectives, leading to defined learning outcomes
  • Assessment of the students' achievement in accordance with the agreed learning outcomes of the training offered
  • A system for collecting, assessing and addressing feedback from learners, teachers, technical / administrative staff and programme / course / module managers
  • Availability of appropriate and regularly reviewed reference material (e.g. published articles, links, book chapters, scripts, etc)
  • Defined and transparent admission criteria
  • Quality assurance of teaching staff
  • Regular review of the QA/QC process and demonstration that the training is further developed in light of this review
  • The facilities, infrastructure, leadership and competences available for the support of student learning
  • University accreditation OR a system for approving, monitoring and reviewing the training offered