Archive: Drug Development and FDA Regulations
Jun 1, 2020, 21:50 PM
Course Id :
19581
Barnett Code :
BI13520
Date :
July 16, 2019
Conf Date :
Jul 16, 2019, 05:00 AM
Price :
735.00
Site License Price :
1735.00
This web seminar provides an overview of the drug development process. Included are the Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Manufacturing Practice (GMP) regulations and how they interact in the drug development process.
- Describe the FDA’s role in drug development
- Review the logic behind the drug development process
- Discuss IND/NDA submissions
- Describe the basics of the clinical trial process
- Describe the FDA review process for IND/NDA submissions
- Navigate the three major FDA regulations: GCP, GLP and GMP
- Those who want an understanding or greater understanding of the drug development process
- Clinical Research Associates
- Auditors
- Regulatory Affairs Professionals
- Quality Assurance Personnel
- Manufacturing Personnel
Elizabeth Ronk Nelson, M.P.H.
Click here for complete trainer
biographies
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.
Sort order :
2019071600000000
jobfunctions :
- Clinical Operations & Trial Management
- Clinical Quality Assurance
- Clinical Research Associate
- Clinical Research Coordinator
- Clinical Research Investigator
- Data Management
- Drug Safety
- Medical Affairs
- Medical Writing
- Nursing
- Project Manager
- Quality Control
- Regulatory Affairs
- Study Site Compliance
- Training
series :
- Clinical Trials & Translational Medicine
content Id :
203980
urlAliasnm :
Web-Seminar-Archives/Drug-Development-and-FDA-Regulations-July-2019/