OUTCOMES

Upon successful completion of this program, you will be able to:

1. Shepherd new medical products (drug, device, biologic) through regulatory, clinical and quality assurance aspects
2. Identify and apply essential aspects of the clinical trial process
3. Access regulations, guidelines, application procedures and reviews used by the Food and Drug Administration (FDA), International Commission on Harmonization (ICH) and International Organization for Standardization (ISO)
4. Identify, analyze and apply business and economic factors important to regulatory affairs for the pharmaceutical and medical device industries
5. Identify, manage and react to medical risk
6. Write effective, accurate technical documents and reports
7. Undertake professional responsibilities in a drug, medical device or related company
8. Prepare efficiently for professional certifications such as those from the Regulatory Affairs Professional Society (RAPS), the Clinical Research Associate (CCRA) and Clinical Research Coordinator (CCRC)