Title:
Training course on How to Prepare for Pharmacovigilance - Audits and Inspections in Europe
Date(s) And Time(s):
Apr 27 2010 9:00AM - Apr 27 2010 5:30PM
Location:
Marriott Rive Gauche
17 , Boulevard Saint Jacques
75014 Paris
France
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.
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
Target Audience:
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.
Event Code:
10551
Contact Information:
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
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