Understanding Regulatory & Clinical Information Systems During Product Development

• Describe several types of information systems used in life sciences
• Define roles and skills required for information system professionals
• Explain the major steps of the information life cycle
• Identify document types required for regulatory submissions
• Describe the major “domains” of information production
• Explain the product, clinical trial and document life cycles
• Explore new strategies for dealing with cultural change and organizational challenges
• Develop a simple process using the roles of author, reviewer and approver
• Examine some of the emerging standards and the importance on them in the future

Course Description

This course provides a unique view of life science for professionals who need to understand the documents, data and records required across the product development process.   Information systems can be a broad area to explore so this course will focus on the process, people and regulations involved in using systems and producing the required outputs.   Participants will understand the difference between an “informatics view” vs.  a “technology view”. 

Additionally, attendees will learn how to evaluate information challenges that include assessment of technology (EDM systems), regulations and their impact (FDA, ICH, other authorities), and business processes (how things need to work to leverage new technology) as well as the intersections of these areas.

The course provides insights for people who may have limited experience in life science and need to understand “the big picture” as it concerns information sources, data flow, usage and management.  A focused approach will be used to consider regulations combined with examples of documents and process models.  Participants will gain insight across the broad spectrum of product development activities and develop an improved information perspective that will be of benefit when working within their own organizations and system implementation strategies