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How to Prepare for Pharmacovigilance Audits and Inspections

Nov 3 2014 8:30AM - Nov 4 2014 12:30PM | Hotel Novotel Paris Charenton 3-5 place des Marseillais 94227 Charenton Le Pont, 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

Participants will complete a knowledge check at the end of the course and will be provided with feedback to ensure learning objectives are attained.

Hotel & Travel 

DIA has blocked a limited number of rooms at the following hotel:

Hotel Novotel Paris Charenton
3-5 place des Marseillais
94227 CHARENTON LE PONT
FRANCE

Tel (+33)1/46766060
Fax (+33)1/49776800
E-mail H1549@accor.com
Website http://www.novotel.com/gb/hotel-1549-novotel-paris-charenton/index.shtml

at the rates of EUR 150.00 per room inclusive of breakfast and exclusive of VAT.
To make your reservation please use the hotel booking form.

Important: The room rate is available until 22 September 2014 or until the group block is sold-out, whichever comes first.

In case of cancellation: The room can be cancelled 43 hours prior arrival, after that the credit card will be charged for the 1st night.

The Hotel Novotel Paris Charenton is located 10 minutes from Gare de Lyon train station, the vibrant Bastille district & Bercy. The liberté metro station (line 8) opposite the hotel gives direct access to Paris's main attractions like Place de la Concorde, Eiffel Tower, Opéra, etc.

Contact Information 

Registration Questions
DIA Europe, Middle East and Africa
Contact Center
Phone.: +41 61 225 51 51
Fax: +41 61 225 51 52
Monday-Friday 8:00-17:00 CET
diaeurope@diaeurope.org

Agenda and Event Logistics
Gunta Sveke, Event Manager
Phone: +41 61 225 51 55
gunta.sveke@diaeurope.org

Faculty 

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Agenda  

Day 1 Monday, Nov 03, 2014

  • 8:30AM - 9:00AM (Central Europe Standard Time)

    REGISTRATION
  • 9:00AM - 10:30AM (Central Europe Standard Time)

    Session 1: THE BASICS
  • 10:30AM - 11:00AM (Central Europe Standard Time)

    COFFEE BREAK
  • 11:00AM - 12:30PM (Central Europe Standard Time)

    Session 2: EUROPEAN AND FDA INSPECTIONS
  • 12:30PM - 1:30PM (Central Europe Standard Time)

    LUNCH
  • 1:30PM - 3:00PM (Central Europe Standard Time)

    Session 3: PHARMACOVIGILANCE REQUIREMENTS AND FINDINGS
  • 3:00PM - 3:30PM (Central Europe Standard Time)

    COFFEE BREAK
  • 3:30PM - 5:00PM (Central Europe Standard Time)

    Session 4: RESPONDING TO THE FINDINGS AND PREPARING THE CAPA
  • 5:00PM - 6:00PM (Central Europe Standard Time)

    DRINKS RECEPTION

Day 2 Tuesday, Nov 04, 2014

  • 8:30AM - 10:00AM (Central Europe Standard Time)

    Session 5: ONSITE AUDIT / INSPECTION
  • 10:00AM - 10:30AM (Central Europe Standard Time)

    COFFEE BREAK
  • 10:30AM - 12:00PM (Central Europe Standard Time)

    Session 6: PREPARATION FOR AUDITS AND INSPECTIONS
  • 12:00PM - 12:15PM (Central Europe Standard Time)

    COURSE ASSESSMENT

Registration Fees 

Member

Charitable Nonprofit/Academia Member
€605.00
Member Government
€605.00
Member Standard
€1210.00

Non-Member

Charitable Nonprofit/Academia Nonmember
€735.00
NonMember Government
€735.00
NonMember Standard
€1340.00
Register Online
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