Title:
Training course on: An Introduction to Product Information Management (PIM)
Date(s) And Time(s):
Apr 26 2010 8:00AM - Apr 27 2010 5:30PM
Location:
Hotel Austria Trend Savoyen
Rennweg 16
1030 Vienna
Austria
Interest Area(s):
Medical Communications,Pharmacology,Quality Assurance/Quality Control,Regulatory Affairs
Overview:
PIM is a new method of submitting product information in the Centralised Procedure (CP). With more than 20 different languages in the EU leading to 1000 or more documents for a single trade name, there is an increased burden on applicants and authorities to handle information for packaging leaflets and product characteristics, especially during the time critical translation process. PIM has been introduced by the EMEA to increase efficiency during exchange of product information and improve the quality and constancy of product information.
This training course is designed to give the participants a good understanding about Product Information Management, the PIM submission process and variations, the translation process and comment handling as well as the exchange standard and templates used.
Key Topics
- PIM Essentials
- Initial Submissions
- Comment Handling
- Translation Process
- PIM Variations
- LAT – The Light Authoring Tool
Learning Objectives:
At the conclusion of this course, participants should be able to:
- Explain the procedures for Product Information Management
- Discuss the Product Information Management submission process and variations
- Describe the translation process and comment handling
- Recognise the exchange standard and templates
Target Audience:
Professionals in:
- Document Management
- Information Technology / e-Business
- Marketing / Advertising
- Medical Communications / Information
- Manufacturing: Drug Substance, Drug Product, Packaging
- Quality Control / Quality Assurance
- Regulatory Affairs / Policy / Drug or Device Approval / GRP
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:
10541
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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