O-STA

"Strongly Recommended" and "Invaluable": PIM and TVT

The 22nd Annual DIA EuroMeeting

Monaco, March 2010. "To PIM or not to PIM?" That's not the question. PIM (Product Information Management) will become the EMA-answer to long-standing, troublesome questions about product information and consistency. To get the answer right and ready as quickly as possible, a reliable text comparator like TVT (Text Verification Tool) from Schlafender Hase will play a crucial role.

At the PIM session on March 10, certain things became clear. PIM will become the standard for the future. During the Q&A session following the presentations, the debate about whether PIM would become "mandatory" or remain simply "strongly recommended" became a moot question. A high-ranking EMA spokesman left no doubt about the intent behind "strongly recommended"; "strongly recommended" means that by the end of 2012 there will be no alternative to PIM for Centrally Registered Products.

Lynsey Flitton, Senior Regulatory Labelling Manager, Pfizer, UK, also made it clear that achieving full implemation of PIM by the end of 2012 would be no easy task. In her presentation of "Practical Experiences of Migrations" during the pilot phase, she stressed how time-consuming the migration process was and how important it is to check the quality of all documents to be migrated. To date, she has worked on two products. In the first case she did not use a text verification tool, in the second case she did. Her recommendation to use a text verification tool could not be stronger: A tool such as TVT is simply "invaluable."

Willie Schnaubelt, Managing Director at Schlafender Hase, put it another way: "TVT is already PIM ready and can play a key role in getting the entire industry PIM ready."

For more Information contact:

Willie Schnaubelt
+49 69 2444-8112

or

Carsten Holinski

+49 69 2444-8115