Available on demand (Originally presented on 9March 2021)
- Introduction to DWL (past & present). DWL has a long history of translating product information for EU marketing authorisations and can offer advice on tackling this small but important step to a successful marketing authorisation application.
- Summary of translation activities relating to centralised, decentralised procedures for EU Marketing Authorisations, including a run-through of DWL’s Centralised Procedure pathway – from first draft to submission.
- Guide to possible translation roadblocks on the pathway to submission.
- A selection of case studies to demonstrate the range of ways our clients work – pros and cons of each approach.
- How different is the approach per company for handling product information?
- How do they manage document review by company affiliates?
- How do they combine several variations within one set of product information?
- How is version control monitored (or not)?
- Summing up and Q&A.
This webinar is sponsored by Dora Wirth (Languages) Ltd.
Disclaimer: Whilst TOPRA is running this webinar for DWL, this is not an endorsement of DWL, DWL's affiliates, employees or its products and services. TOPRA is also not responsible for the content or views expressed during the webinar.
The session will take you through general translation requirements for an EU Marketing Authorisation Application. After the introduction we will identify challenges and opportunities relating to the efficient handling of product information for Centrally Authorised Marketing Authorisations:
- Key translation milestones on the path to a successful marketing authorisation
- Do’s/Don’ts of handling product information
- When to involve local affiliates in the review of translated materials
- How shortcuts could put your submission at risk
- Case studies showing how your competitors involve their language service providers (LSPs) in the regulatory submission process.
- Translation Buyers
- Regulatory Affairs Managers
- Regulatory Affairs Directors
- Regulatory Affairs Associates
- Regulatory Affairs Specialists
Dora Wirth Languages Ltd.
Craig Brown is Chief Marketing Officer at Dora Wirth (Languages) Limited, headquartered in London, UK. Since obtaining his undergraduate degree in French at Oxford Brookes University he has worked for two major language service providers, and has spent the last 10 years specialising in translations for the Life Sciences industries. Dora Wirth (Languages) Limited delivers specialist translation solutions to customers involved in clinical research and regulatory affairs around the globe.
Business Development Director
Dora Wirth Languages Ltd
Eleni Andreou is the Business Development Director at Dora Wirth (Languages) Limited. With over 10 years of experience in Translation and Project Management within the Life Sciences sector and having served some of the world’s leading Pharma and Medical Devices companies, Eleni has recently taken over the Business Development activities at Dora Wirth (Languages) Limited, with her utmost goal being to provide highest quality translation solutions to their global clients. Eleni holds a Diploma in Foreign Languages and Translation (Ionian University) and a MA in Technical and Scientific Translation (University of Surrey) and has previously worked for a couple of the top 10 LSPs globally within their Life Sciences teams.
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