DUBLIN--(BUSINESS WIRE)--The "Technical Writing for Pharma, Biotech and Medical Devices" training has been added to ResearchAndMarkets.com's offering.
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
- 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
Key Topics Covered:
Day 01 (10:00 AM to 5:00 PM EDT)
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 to 5:00 PM EDT)
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
For more information about this training visit https://www.researchandmarkets.com/r/iwpfj3
