Biopharmaceutical & Pharmaceutical Training & Technology, Medical Device & Biotech Training - CfPIE
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Writing in the Regulated Environment When English Is Your Second Language




Who Should Attend


This is a course for people whose native language is other than English and who must write documents in support of therapeutic product development or regulatory submissions. This course is valuable for pharmaceutical, medical device, and biotech professionals in drug discovery, product development, quality assurance, clinical testing, information technology, and regulatory affairs who have some understanding of English, but wish to refine their writing skills. It is also helpful for native-born writers who want to better understand the English language and how to control it.



Learning Objectives

Upon completion of this course, attendees will:
  • Understand why a good command of English is critical to satisfy the binding regulations
  • Understand why English poses different problems for speakers and writers of different languages
  • Have increased understanding of the structure of American English
  • Have the tools to continue to build your vocabulary
  • Understand sentence patterns in English and how to control them
  • Be able to build sentences using subordinate clauses, phrases, and other modifiers
  • Better understand the way articles and prepositions work
  • Know how English tenses work and how they drive most of the writing that occurs in industry
  • Recognize how to use the third person, the imperative voice, and the active and passive voices
  • Know how to use standard punctuation
  • Have better tools for producing concise, and complete documents
  • Be able to control the language so that every word counts and messages are clear to readers



Course Description

This course presents a comprehensive overview of the structure of American English to give non-native writers of English the tools they need to produce clear, complete, and comprehensive documents. Participants will learn about English within the context of the type of writing the therapeutic products industry requires. The course covers the structure of the language and how to control the individual components, as well as the choices writers have in delivering messages.

The course also addresses specific aspects of English that are problematic for individual participants. Attendees should come prepared with specific questions they want answered during the course.



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Certification Programs available for this Course:
Current Good Laboratory Practices (cGLP) Certified Compliance Professional (GLPCP)

Related Courses:
European Filing & Registration Procedures
Introduction to Effective Medical Writing
Technical Writing for the Pharmaceutical, Medical Device, and Biotech Industries
Writing Effective Standard Operating Procedures and Other Process Documents
Preparation of FDA Submissions (INDs, NDAs, BLAs, ANDAs, Post-Approval Supplements) and Communicating with the FDA



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