SDL and EXTEDO Joint Seminar: A Step-by-Step Guide to PIM

Event Type: Conference

Dates: 17 November 2009
From: 09:00 to 16:00 (GMT +1:00) Amsterdam, Berlin, Rome, Stockholm, Vienna
Venue: Frankfurt Airport Conference Center

PIM - Submission Simulation Workshop

Registration for this seminar is now closed. Register for the next PIM seminar which is being held in Vienna on December 2nd.

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.

Seminar Information

Date	Tuesday, 17 November 2009
Venue	Frankfurt Airport Conference Center - http://www.acc-frankfurt.de/
Time	Registration at 9:00am Workshop from 10:00am to 4:00pm

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.

Seminar Program

10:00	Introduction to PIM Key Concepts - “Mini PIM Crash Course”
10:30	Coffee Break
10:45	Introduction to the PIM environment “PRS, Labeling System, XML Translation Management”
11:15	Simulation Start (Day 120) Structuring your Product “English Baseline”
12:00	Lunch Break
13:00	Initial Translation (~ Day 150)
13:45	Answering to Rapporteur Comments
14:00	Updating Translations (Day 150-215)
14:15	Linguistic Review Answering HA Comments
14:35	Coffee Break
14:45	Type II Variation
15:00	Migration Considerations
15:30	Case Study - Software, Timeline, Project plan, Services
15:50	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.