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Overview

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.

Who should attend?

Professionals who work in:

  • Pharmacovigilance / Drug safety (QPPV)
  • Regulatory affairs
  • Quality & compliance
  • Information technology
  • Medical information
  • Risk management

CANCELLATION POLICY

Cancellations must be made in writing and be received at the DIA Europe office five working days prior to the course start date.
                                                                                        
Cancellations are subject to an administrative fee:
Full Meeting Cancellation:

Industry (Member/Non-member) = € 200.00
Government/Academia/Non-profit (Member/Non-member) = € 100.00

Registrants who do not cancel five working days prior to the course start date and do not attend, will be responsible for the full registration fee. DIA Europe reserves the right to alter the venue and dates if necessary. If an event is cancelled DIA Europe is not responsible for airfare, hotel or other costs incurred by registrants. Registrants are responsible for cancelling their own hotel and travel reservations.

Transfer Policy

You may transfer your registration to a colleague prior to the start of the event but membership is not transferable. Substitute registrants will be responsible for the non-member fee, if applicable. Please notify the DIA Europe office of any such substitutions as soon as possible.

Learning objectives

At the conclusion of this course, participants should be able to:

  • Prepare their function for an audit / inspection: roadmap, teams, tasks, and documents;
  • Prepare responses to audit / inspection findings, including responses and corrective / preventive action (CAPA) plans
  • 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.
  • Participate in audits / inspections and mock audits / inspections.
  • Assess Regional differences with respect to European and US FDA inspections

Contact us

DIA Europe

ELISABETHENANLAGE 25, POSTFACH

4002 BASEL

SWITZERLAND

 

TEL.: +41 61 225 51 51

FAX:  +41 61 225 51 52

E-MAIL: DIAEUROPE@DIAEUROPE.ORG