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How to Prepare for Pharmacovigilance Audits and Inspections

Nov 7 2013 1:30PM - Nov 8 2013 3:30PM | Mercure Paris la Villette 216 Avenue Jean Jaures 75019 Paris France

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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
  • Compliance
  • Pharmacovigilance Auditors
  • Management Staff Responsible for Running Inspections
  • Employees (directly and indirectly) Involved in Inspections

COURSE LEVEL
For professionals with 2-3 years of experience in pharmacovigilance this course will be at an intermediate level; professionals with experience from the auditing area will find this course to be at a beginner level.

Learning Objectives 

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

Hotel & Travel 

Contact Information 

DIA Europe
Kuechengasse 16
4051 Basel, Switzerland

Phone: +41 61 225 51 51
Fax: +41 61 225 51 52
Email: diaeurope@diaeurope.org

Faculty 

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Registration Fees 

Member

Charitable Nonprofit/Academia Member
€578.00
Member Government
€578.00
Member Standard
€1155.00

Non-Member

Charitable Nonprofit/Academia Nonmember
€693.00
NonMember Government
€693.00
NonMember Standard
€1270.00
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CANCELLATION POLICY: All cancellations must be made in writing and received at the DIA office five working days prior to the event start date. Full event cancellations are subject to an administrative fee:

  • Industry (Member/Non-member) = €200.00
  • Academia/Charitable/Government /Non-profit (Full-Time) (Member/Non-member) = €100.00
  • Tutorial cancellation: €50.00

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

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