Wednesday, 26 April 2017
Successful submissions include clear and compelling data demonstrating the safety and effectiveness of your product. Writing test reports that meet current regulatory and quality expectations is critical. But test reports can include a great deal of irrelevant or confusing information, especially to an agency person reading them for the first time. Good test summaries highlight and interpret important findings, explain complicated topics, address unusual findings and persuade the reader that your product is safe and effective.
In this webcast, you will learn about required elements of good test reports and important elements of test summaries. The goal is not just to improve your technical writing skills, but to improve your ability to persuade others of the safety and effectiveness of your product.
Learning Level: Intermediate
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
Upon the webcast's conclusion, you will be able to:
- Understand the basic elements of a GLP-compliant test report.
- Understand the basic elements of a good test summary.
- Understand key strategies and tactics for writing persuasively.
Who should attend
- Regulatory specialists who summarize test reports.
- Engineers and scientists who write test reports.
- Regulatory, engineering, and scientific managers who review test reports or test summaries.
Dan Dillon, senior regulatory scientist, MED Institute
Justin Metcalf, director of engineering services, MED Institute