The Center for Professional Innovation & Education (CfPIE), Malvern, PA
Feb. 22 & 23, 2007
Who Should AttendThis 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, you 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. It 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. ________________________________________
COURSE AGENDA
DAY ONE 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
DAY TWO
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
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