ELIA ND Athens: Life Sciences and Localization, a Complex World

Under Blog | Posted by CETRA Admin

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Marianna Athanasopoulou – ORCO

This session is dedicated to the different sub-verticals within Life Sciences and more in particular pharmaceuticals and clinical trials. LSPs who want to enter this highly-regulated market have to be aware of its complexity and stringent demands and enter the Life Sciences arena well-prepared. Marianna Athanasopoulou from ORCO discussed different areas within pharmaceuticals/clinical trials and also the current EU regulatory requirements for each of these verticals.

  • ORCO was founded in 1983, entered life sciences (LS) sector in 1997
  • What differentiates LS translation from other translation sectors:
    • Highly regulated and formalized environment
    • Quality and accuracy are of critical importance
    • Cultural and linguistic peculiarities
    • Quick turnaround times due to the narrow timeframes for regulatory submission and approval of translations
    • Complex workflows and methodologies
  • Three main categories:
    • Medical devices
    • Pharmaceuticals
    • Clinical trials
  • EU regulatory requirements for pharmaceuticals (European Medicine Agency – EMA):
    • All documentation must comply with the EMA Working Group on Quality Review of Documents (QRD) templates, available in 25 EU language plus Icelandic and Norwegian
    • Strict timeframe of 20 calendar days for submission, validation and finalization of translated version of all documents

    EU regulatory requirements for clinical trials:

    • All patient-facing clinical trial documentation needs to be translated into the language of the trial population
    • European Clinical Trials Directive 2001/20/EC
    • Good Clinical Practice Directive
  • Translation process and management:
    • Use a consistent and formal process
    • Select and train translators
    • Consult with healthcare professionals
    • Review of translation by a second person (medical reviewer)
    • Attempt to achieve direct involvement of the end client
  • Types of content – regulatory documents:
    • Product information
    • Labeling
    • Pharmacovigilance (collecting data on drug safety)
    • PRO instruments, Quality of Life Scales and Questionnaires
    • Informed Consent Forms
    • Protocols
    • Investigator’s brochures
    • Patient and clinician education materials
    • Patient diaries, symptom checklists
    • Adverse events
    • Case report forms
    • Synopses
    • Clinical research and medical reports
  • Types of content – sales and marketing:
    • Websites
    • Training / e-learning materials
    • Marketing communications / press releases
    • Promotional materials
  • Processes:
    • TEP & QE/Review (TEP = translate, edit, proofread)
    • SME review (SME = subject matter expert)
    • FWD Translation 1, FWD Translation 2, Reconciliation, Back Translation, Back Translation Review, Comparative Review
    • Cognitive debriefing / pilot testing
    • Screenshot review, in-context review
    • Bug reporting and fixing
  • Back translation is mandatory in some countries, but not in others
  • Regression: verification of the correct implementation of all corrections and delivery of final files to the client
  • Translation process in LF is 3 to 5 times more expensive than standard translation (in other industries)

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