Would you like to gain a clear understanding of the EMA linguistic review process for Centrally Authorised Products (CAPs)?
This webinar focuses on understanding the EMA linguistic review process for CAPs before approval and during post-authorisation procedures, as well as the required formatting conventions and submission methods.
What will the webinar cover?
During this session, we will explore:
- Translation companies’ ways of working and the use of specific software tools.
- The EMA linguistic review process for CAPs.
- Post-authorisation procedures and special situations.
- Formatting conventions and submission methods.
This webinar is designed for Regulatory Affairs professionals, Medical Writers, QA specialists, and anyone involved in the preparation and submission of regulatory documentation in Europe.
Speakers
- Mª Victoria Tudanca – RA Officer (Asphalion)
- Anna Valsamaki – SVP of Translation Operations (Big Language Solutions)
- Rana Madanat – BD Executive (Big Language Solutions)
Registration Open!
REGISTER HERE: EMA linguistic review process
📩 Contact us: [email protected]
