Module 12 2019

PIM • Product Information Management (PIM) was to provide CTD section 1.3.1 in XML format • EMA decided to close PIM project at the end of March 2011 due to: ▪ Business Process Issues

▪ Budget Implications ▪ New PcV Legislation

“The EMA remains committed to the concept of structured product information and the efficient exchange of information, and will return to the issue once the review process has been completed” In order to optimize processes in Regulatory Affairs, we need structured product labelling solution. For IDMP also required.

The Organisation for Professionals in Regulatory Affairs

Slide 49