Industries: Pharma / BiotechMedical Device

Medical Writing When English Is Your Second Language

Course Director: Kay Monroe

 

Course Fee: $2150.00 Regular Registration / $1950.00 Early Bird (30 Days in Advance)

Medical Writing Training

Course Description - Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)

CfPIE’s medical writing courses present 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. The medical writing training 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.

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. Participants will learn about English within the context of the type of writing the therapeutic products industry requires.  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.

Course Agenda

First Day

Using English Within Regulated Industries

  • Introductions
  • Regulatory requirements for documentation
  • Types of documentation the regulations require
  • Overview of English
  • English in relation to the world's other major languages
  • The most common errors of non-native writers and how to spot them

Vocabulary Expansion

  • English language basics
  • The roles of content and structure words
  • Roots, prefixes, and suffixes
  • Connotation and denotation
  • How words come into the language
  • Sentence patterns and word order in English

Sentence Structure

  • Sentence structures and rules of English
  • Writing strong subjects and verbs in clauses
  • The 12 verb tenses
  • Helping verbs
  • Adverbs of time
  • Sentence building
  • Choices for delivering information

Developing Cohesive Passages

  • Verb phrases
  • Prepositional phrases
  • Paragraph building
  • Providing support for topic sentences

Workshop: Your Writing Style

Second Day

Voice and Sequence

  • Active voice
  • Passive voice
  • Emphatic voice
  • Imperative voice
  • The writer's voice
  • Verbs in sequence

Modifiers

  • Adjective and adverbs
  • Appositive (renaming) structures
  • Making comparisons

Improving Readability

  • Articles and other noun markers
  • Pronouns
  • Indefinite pronouns
  • End marks and internal punctuation

Workshop

  • Revising your own writing
  • Achieving precision and clarity
  • Avoiding the common language bugbears

Learning Objective

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

Frequently Asked Questions

Why is English the Preferred Language for the Healthcare industry?

English is the international business language, and the language of science and technology. It is less difficult to learn than most of the other major languages. It has a simpler tense system and a fixed word order. You can make yourself understood in English, even if the conventions are not perfect. English also offers the ability to be concise – it uses approximately 20% fewer words to convey the same message as, for instance, French or Italian. Only Mandarin Chinese is spoken by more people, but English is more widely spoken around the globe and has wider dispersion than any other language.

How can writers know when to use the infinitive or gerund (e.g., "to see" or "seeing") after a verb?

In English, some verbs can take other verbs in the object spot. Native writers do not question whether to write "plan to go" or "I plan going." Yet for people for whom English is not a native tongue, the two can sound exactly the same, but the latter is idiomatically incorrect. There is only linguistic theory about how these conventions developed. Not all verbs can take other verbs, but many can, and these frequently give non-native writers difficulty. Some verbs can take both the "ing" and the "to" form of verbs with no loss of meaning, as in "I like reading" and "I like to read." Other verbs can take both forms and have different meanings. Consider, " I stopped to talk to him," versus "I stopped talking to him."

So many languages do not use articles ("a," "an," and "the"), so why does English need them?

English, a member of the Germanic group of languages, relies on word order for meaning. Articles serve as noun markers and tell readers which is the naming word (noun) and identify words preceding the noun as modifiers. Consider this sentence -A white cotton lab coat is standard attire in QC. "A" identifies "coat" as the noun, and indicates that "white," "cotton," and "lab" are modifying "coat," even though these words can also be nouns in their own right. And, by the way, the article agrees with the sound of the word that follows it, not the noun, as in An FDA guidance document addresses Part 11.