Course Agenda
Day One  (10:00 AM-5:00 PM)

10:00 AM – 12:00 PM: Lecture 1: Expectations from Regulatory Documents
  • Relationship between technical and regulatory writing
  • Documents required by regulations in the US and EMA
  • Modular and full-scale writing practices
  • Resources needed for writers
  • Scope of writing versus creating data elements

12:00 – 12:30 PM: Break

12:30 – 2:00 PM: Lecture 2: Ground Rules for Writing, Formatting and Updating Content
  • Formatting and version control for content intended for electronic submission
  • Using MS Office elements to create e-ready documents
  • Hyperlinks and cross-links in an XML environment
  • Best practices for MS Word and Adobe PDF in an eCTD environment
  • Best practices for styles in all regulatory documents

2:00 – 2:15 PM: Break

2:15 – 3:30 PM: Lecture 3: Templates and Style Guides
  • Using templates for regulatory documents
  • Individualized and corporate elements in documents
  • Regulatory requirements in documents
  • Best practices for printable and electronically available documents
  • Using tables, figures, cartoons, flow-charts, and other tools to drive a point

3:30 – 3:45 PM: Break

3:45 – 5:00 PM: Lecture 4: Writing for the Audience
  • Writing for the reader: technical appropriateness
  • Granularity requirements
  • Controlling the language and expressions
  • Best practices for evidence based writing: using references and citations
  • Organizing a document and a complete submission
Day Two  (10:00 AM-5:00 PM)

10:00 AM – 12:00 PM: Lecture 5: Quality Control of Documents
  • English as the first, second or third language
  • Non-English writing styles: role of cultural sensitivity in writing
  • Rules for copy editing and content editing
  • Project management for documentation: regulatory requirements
  • Tracking changes: attribution, creating clean and red-lined documents

12:00 – 12:30 PM: Break

12:30 – 2:00 PM: Lecture 6: Common Regulatory Documents
  • SOPs
  • Clinical protocols and study reports
  • Correspondence: Emails, meeting minutes, and notes to file
  • Integrated summaries and reviews of literature
  • Rules for multi-dimensional documents: complete regulatory submission

2:00 – 2:15 PM: Break

2:15 – 3.30 PM: Lecture 7: Common Technical Documents
  • Manuscripts for peer-reviewed publications
  • Informed consent forms
  • Strategy documents
  • Lab notebooks and other laboratory documents
  • Marketing and sales training documents

3:30 – 3:45 PM: Break

3:45 – 5:00 PM: Lecture 8: Attributes of a Skilled Regulatory Writer
  • Researching background material
  • Regulatory intelligence
  • Gap analysis and strategy reports
  • Training technical writers in regulatory writing
  • Matrices for evaluating writing skills