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.
- PIM Essentials
- Initial Submissions
- Comment Handling
- Translation Process
- PIM Variations
- LAT – The Light Authoring Tool
Who should attend?
- 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
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