An Introduction to Product Information Management (PIM)

Date(s) And Time(s):
Oct 28 2010 8:00AM - Oct 29 2010 5:30PM

Location:
Novotel
Rue de Zurich 19
1201 Geneva
Switzerland

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

Event Code:
10539

Contact Information:
DIA Europe
TEL.: +41 61 225 51 51

FAX: +41 61 225 51 52

E-MAIL: DIAEUROPE@DIAEUROPE.ORG

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