Anabel Pérez is one of our Senior Project Managers here at ForeignExchange Translations. She has been involved in the medical localization field since 2004 in a variety of roles from freelance translator to in-house proofreader and localization project manager.
Over this period, Anabel has gathered a lot of know-how around EMA submissions. She understands that translating product information documents in preparation for an EMA submission can be a frustrating, complex, and lengthy process for both pharmaceutical companies and their translation providers. However, by establishing and maintaining communication from the start of the project, and by working together to establish realistic timelines and achievable milestones, many of the common headaches can be avoided.
In her presentation Meeting the Linguistic Requirements for EMA Submissions, looks at the pain points encountered when translating for an EMA submission and proposes solutions, innovations, and best practices that will allow client and medical translation supplier to work together collaboratively to meet all the EMA requirements.
Anabel's presentation covers:
- Project start-up – start right to finish well (communication protocol, scheduling, linguistic strategy)
- QRD requirements (linguistic and formatting)
- Tools for QA (QRDetect™)
- Pain points: affiliate & member state review, timetables, change management
- Post-mortem process: learning and improving
For related information, take a look at the following:
- Complying with EMA's New Mandatory Requirements for Medicinal Product Information (EVMPD)
- QRD templates are imperfect, getting better
- QRD compliance just got easier thanks to QRDetect
- Requirements for readability testing of PILs
ForeignExchange Translations provides specialized medical translations for electronic as well as paper-based regulatory submissions. Contact us to find out more.