Workshop 3

Medical Writing in Drug Development (2 Days)

Tutors: Prof. Pieter Joubert, MBBCh, FCP(SA), M.D. (Internist, Clinical Pharmacologist)
Dr. Silvia M. Rogers, Ph.D. (Pharmacologist)
Target audience: Scientists/physicians in drug development, medical writers, administrative assistants, marketing personnel, etc.

Course Program

  • The Big Picture
    • An outline of the drug development process from pre-entry-into-humans to the market, highlighting the key documents, e.g., Investigator's Brochure (IB), Investigational New Drug (IND) applications, Investigational Medicinal Product Dossier (IMPD), Clinical Trial Exemption Certificate (CTX), Protocols, Clinical Trial Reports, New Drug Applications (NDAs), including the Common Technical Document, Clinical Overview, package insert, and related documents
    • Target audience for these documents
    • Key messages

 

  • The Basics of Medical Writing
    • Orientation: good versus 'poor' medical writing
    • Creative versus scientific writing
    • The purpose of medical writing
    • Common problems in medical writing

 

  • Six Rules for Better Medical Writing
    • Active versus passive verbs
    • Prepositions
    • Tenses
    • Parallelism
    • Modifiers
    • Punctuation

 

  • Preparing an Abstract
    • What is a good abstract?
    • Exercise: Preparing an abstract, bearing the target audience in mind

 

  • Sensible Use of Tables and Graphs
    • Preparing user-friendly displays

 

  • International Conference of Harmonization (ICH) Guidelines with Emphasis on Clinical Trial Reports
    • Guidelines versus rules
    • Components of Clinical Trial Reports

 

  • The Clear Message in Medical Writing
    • Matching data with the label
    • Assuring consistency
    • Document standards
    • Messages and conclusions

 

  • Preparing a Poster
    • What is a good poster?
    • Exercise: Preparing a focused mini-poster

 

  • Registration Documents (with Emphasis on the Clinical Overview)
    • Critical evaluation of the NDA
    • Identifying the issues
    • Dealing with strengths and weaknesses
    • Being 'up-front'

 

  • Discussion