At this BASG meeting, we will inform you about the correct preparation of product information and package leaflets for medicinal products. Labelling and mock-ups are also on the agenda.
Contents
- Information flow - from module 4/5 to SmPC (Summary of product characteristics)
- Compulsory prescription/prescription order
- Excipients in PIL (Product Information) and LAB (Labelling)
- Information flow - from Module 3 to SmPC (Summary of product characteristics)
- "Mockups of primary and secondary packaging"
- National phase according to MRP/DCP - How to make your regulator happy
Target group
- Regulatory employees from authorisation departments and
- Employees of consulting companies in the pharmaceutical industry
Language
German
Registration information
Please registerat by 13 November 2025 at the latest.
This event will be held as an online-only event .
Technical management
Dr Peter Platzer
Institute for Marketing Authorisation & Life Cycle Management
Medical Market Surveillance Division, AGES GmbH
It is possible to submit general questions on the lecture topics in advance, which will be addressed as far as possible in the context of this BASG discussion.
In this case, please send an e-mail to akademie@ages.at by 24.10.2025 and state Labelling Day for Human Medicinal Products and the title of the lecture to which your question relates in the subject line.