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.
The training will be delivered virtually through WebEx. 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.
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
- Ensure technical documents achieve maximum impact by efficiently structuring the data and avoiding common mistakes in written English
- Analyze experimental data using statistical principles
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)
- Writing effective procedures
Course Content
Day 01
10:00 AM -10:30 AM
- Regulatory expectations
- ICH, US FDA and EMA guidance on eCTD submissions
- How much information to include
10:30 AM -10:45 AM Break
10:45 AM -12:00 Noon
- Writing appropriately for the audience - who will read your report?
- Organization and structure of technical reports
- Use of templates
- Conventions and style in scientific writing
- Correct use of English
- Length and structure of sentences
- Citing scientific literature
- Exercise: identifying and correcting poor writing
12:00 Noon -1:00 PM Lunch
1:00 PM -3:00 PM
- Statistical methods
- Types of data distribution
- Basic statistical terms and techniques
- Tests for normality
- Outliers
- Analysis of variance
- Introduction to experimental design
- Exercise: using appropriate statistical techniques
3:00 PM - 3:15 PM Break
3:15 PM - 4:30 PM
- Graphical presentation of data
- Options for presenting data in technical documents
- Designing effective figures and tables
- Use of error bars
- Graphics tools in Microsoft Excel®
- Exercise: selecting appropriate data presentation methods
Day 02
10:00 AM -10:30 AM
- Writing effective procedures
- Differences in style between technical reports and procedures
- SOP structure
- Developing an effective procedure - risk-based approach
- Use of diagrams and pictures
- Procedure lifecycle management
- Regulatory observations
- Exercise: reviewing a SOP
10:30 AM -10:45 AM Break
10:45 AM -12:00 Noon
- Workshop/group exercise: review of example reports - identifying good and bad practice
12:00 Noon -1:00 PM Lunch
1:00 PM -3:00 PM Report-writing workshop
3:00 PM -3:15 PM Break
3:15 PM -4:15 PM Report-writing workshop (continued)
4:15 PM -4:30 PM Final questions, feedback and close
Course Provider
Dr Mark Powell,
Fellow ,
Royal Society of ChemistryDr Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as an analytical chemist. Mark was Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016, when his term of office ended. Between 2003 and 2013, he was the Analytical Development Manager, and later Scientific Manager, of a UK-based contract research organization which specialized in early-stage oral drug development. During this time, he was responsible for method validation, verification and transfer activities, as well as the qualification of laboratory instruments and computerized data systems. In 2013, he set up Mark Powell Scientific Limited, which provides training and consultancy services to pharmaceutical companies. Mark has since enjoyed working with companies of all sizes around the world on a variety of training and consultancy assignments, and has recently co-authored a White Paper on Pharmaceutical Data Integrity for the laboratory supply company VWR.
Who Should Attend
- Regulatory affairs professionals
- Project managers
- Technical staff with responsibility for report/procedure writing
- Quality management
