Technical Writing for Pharma, Biotech and Medical Devices

The quality and clarity of written technical documents is vital to the success of pharmaceutical companies. Such documents are used in regulatory submissions, to report the outcome of development work to clients, to record the results of investigations and to guide the direction of internal projects. In this course, participants will learn how to analyze and present technical data in a clear and concise manner. The use of visual tools such as graphs and flow charts will be covered, together with the design of effective tables. Statistical tools for data reduction and analysis will also be covered. The elements of effective standard operating procedures will also be explained. A large part of the course will be spent in a workshop setting, where attendees will produce technical content for comment and evaluation. The workshop can either be based on participants’ own data or model data provided by the trainer.

Attendees will be expected to bring a laptop computer. By the end of the course, attendees will be able to:

• Understand the expectations of regulators when reviewing a NDA/BLA/MAA
• Edit documents to remove superfluous words or phrases
• Identify and correct ambiguous text
• Write effective technical reports and procedures that cater to the needs of their target audience
• Present complex experimental data in a logical, clear and concise manner making optimal use of graphs, charts and tables
• Follow the conventions of scientific writing to support explanations and arguments

Learning Objectives:

• Information required in regulatory submissions
• eCTD format and style
• The fundamentals of effective writing: accuracy, brevity and clarity
• Common mistakes in written English
• Effective use of figures and tables
• Correct methods of citing literature sources in technical documents
• Types of data distribution
• Statistical treatment of experimental data
• Design of Experiments (DoE)

Who will Benefit:

• Regulatory affairs professionals
• Project managers
• Technical staff with responsibility for report/procedure writing
• Quality management