Welcome to this webinar hosted by TOPRA (The Organisation for Professionals in Regulatory Affairs).
In the session we examine how our customers overcome translation hurdles on the path to successful marketing authorisation applications in Europe. We offer actionable advice and tips when managing new submissions/variations and promote accuracy during the Opinion and post-Opinion linguistic review stages.
The webinar will be of interest if you are required to provide translated product information to the EMA, and need to know how to overcome translation hurdles along the way:
- the language requirements for marketing authorisations via the Centralised Procedure.
- challenges faced when producing QRD-compliant translations.
- how to approach Member State comments at the linguistic review stage.
1. The recording begins with an introduction to Dora Wirth (Languages) Limited. We describe our long history of translating product information for EU marketing authorisations.
2. Summary of translation requirements on the path to EU Marketing Authorisations, including a run-through of DWL’s Centralised Procedure pathway – from first draft to submission.
3. DWL outlines possible translation hurdles on the pathway to submission.
4. Finally, Eleni delivers a selection of case studies to demonstrate how our clients approach the translation process (with pros and cons for each).
– What are some different approaches per company for handling product information?
– How do they manage document review by company affiliates?
– Can you safely combine several variations within one set of product information?
– Is version control monitored by all clients?
5. Summing up and Q&A.
We hope you enjoy this video content. Come up with a personalised translation strategy for your MAA can be difficult. DWL has many years planning and translating product information for EU marketing authorisations.
For more information about our services for EU Marketing Authorisations, or for anything else, get in touch via telephone or email.