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 this audio conference presentation, our speaker outlines the pain points often encountered when translating for an EMA submission, and proposes solutions, innovations and best practices that will allow client and supplier to work together collaboratively to meet all the EMA requirements, and make for a smoother submission.

This audio conference 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

About the speaker:

Anabel Pérez is a Senior Project Manager at medical translation specialist ForeignExchange Translations, Inc. 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. Anabel has assisted leading medical device and pharma clients such as GE Healthcare, MAQUET, Eli Lilly and Merck in improving the processes and quality of their translation projects. She holds a first-class BA degree in Modern Languages from the University of Sheffield (England) and an MA degree in Technical and Specialized Translation from the University of Westminster (England). She is bilingual in Spanish and English, and cites languages and music as her main passions.

Who should attend?

• Translation Project Managers
• Product Specialists or Managers
• Regulatory Affairs Managers
• Project Managers
• Account Managers
• Sales Managers