The course, a Thomson Reuters Cortellis Regulatory Online Learning module, describes the overall drug development process in detail. It discusses the importance of a global development program and of a regulatory strategy for obtaining and maintaining drug marketing authorizations. The course outlines the roles and responsibilities of regulatory affairs professionals. It concludes by demonstrating that regulatory and competitive intelligence are indispensable tools for strategic decision-making.
- Drug development process
- Global drug development
- Regulatory strategy for obtaining and maintaining drug marketing authorizations
Who should attend?
Professionals and experts in the pharmaceutical, biotechnology, and medical device fields
Participants who complete this course should be able to:
- Identify the studies involved in the drug development process
- Explain the objectives of the four phases of clinical studies
- Identify the major issues encountered by the pharmaceutical industry today
- Understand the importance of a global development programme and a regulatory strategy
- Describe the purpose of Regulatory Affairs
- Explain the roles and responsibilities of a Regulatory Affairs professional
- Identify the main resources for regulatory and competitive intelligence
The course takes an average of one hour to complete.