A Step-by-Step Guide to PIM (EXTEDO, SDL), 17 Nov 2009, Frankfurt, Germany

The EMEA has announced its intention to formally end the PIM pilot phase in the summer of 2010. At that time PIM will be strongly recommended for (a) all new marketing authorization applications and (b) all post-marketing authorizations based on already migrated products. Then, PIM will be strongly recommended for all CP submission activities by the end of 2011.

Read the EMEA statement here.

Several companies implemented a PIM solution during the PIM pilot phase. It took them from 18 to 30 months to implement it and roll it out in production. Companies who want to comply with the EMEA recommendations should plan now for getting ready for PIM.

Agenda Overview

EXTEDO and SDL offer a joint solution that successfully supported PIM submissions during the PIM pilot phase. This workshop is intended to sum up the lessons learned and to guide participants step by step through an initial submission and a Type II Variation in a very ‘hands-on’ way. The workshop will highlight all the differences with the current Word processes and should help participants to prepare for PIM.

 
Who should attend?

• Regulatory Affairs Staff
• Regulatory Labeling Specialists
• Submission Managers
• Regulatory IT Staff
• Local in-country personnel dealing with translations and translation outsourcing (Affiliate staff members)

This seminar is free of charge but places are strictly limited to industry professionals only.

Registration: Klick here for online registration

Seminar Program

09:00 Registration

10:00 Introduction to PIM Key Concepts - “Mini PIM Crash Course”

10:45 Coffee Break

11:00 Introduction to the PIM environment “PRS, Labeling System, XML Translation Management”

11:30 Simulation Start (Day 120) Structuring your Product “English Baseline”

12:00 Lunch Break

13:00 Initial Translation (~ Day 150)

13:30 Answering to Rapporteur Comments

14:00 Updating Translations (Day 150-215)

14:30 Linguistic Review Answering HA Comments

15:00 Type II Variation

15:15 Migration Considerations

15:45 Wrap-up
 

Your Speakers

• Matthias Heyn, MA (linguistics and information science) holds a position as VP Solutions Europe at SDL International. He specializes in consulting life sciences organizations concerning multilingual aspects for clinical, regulatory or post-authorization situations. He advised almost all companies who submitted products in the framework of the EMEA PIM pilot. Matthias Heyn has expertise in global information management, translation management and related technology. He has worked in his career for TRADOS Germany as a software engineer and in business development, he has founded TRADOS in Benelux and TRADOS in Japan. He has worked as lecturer at the University of Heidelberg. He has published in the field of computational lexicology and computational linguistics and in regulatory affairs issues.
   
• Schei Dattner, EXTEDO has more than 5 years active for EXTEDO in the selling and implementation of regulatory software solutions and services including document management solutions. Schei has over 15 years experience in document and content management based on XML (and SGML) technology focused on process oriented solutions to support the creation, publishing and translation process of structured content.

Location:

Frankfurt Airport Conference Center (www.acc-frankfurt.de), Frankfurt am Main, Germany

Download event information