A UL course
This course will provide an overview and summary of the regulatory history of the US Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH), and the requirements for ensuring proper and successful clinical trial execution. This module includes some of the history behind today’s system of drug and device development. Participants who take this course will be able to recognize the evolution of the industry and the FDA. Learners will understand the ICH and its global impact on the medical product industry.
- Standards for pharmaceutical and medical device development
- US and international regulatory organizations
- Regulations and guidelines
Who should attend?
Professionals and experts in the pharmaceutical, biotechnology, and medical device fields