Archive: EMA and FDA Inspections: Key Differences and Similarities
Jun 1, 2020, 21:50 PM
Course Id :
15708
Barnett Code :
BI12570
Date :
October 25, 2016
Conf Date :
Oct 25, 2016, 09:00 AM
Price :
735.00
Site License Price :
1735.00
In this web seminar, key differences and similarities
between the European Medicines Agency (EMA) and U.S. Food and Drug
Administration (FDA) inspection procedures and processes will be discussed,
including their collaborations on official joint Good Clinical Practice (GCP)
inspections of sponsors, CROs, and investigational sites. The published results
of the Pilot EMA-FDA GCP Initiative will also be reviewed using recent examples
of joint inspections. Clarification will be provided for reporting of Serious
Breaches in the United Kingdom along with a review of common inspection
findings.
- Describe the EMA and FDA
inspection processes
- Clarify reporting of
Serious Breach requirements
- Review inspection findings
of FDA-EMA joint inspections
- Quality Assurance
Personnel (Auditors, Compliance Officers)
- Clinical Trial Managers
- Clinical Research
Associates
- Project Managers
- Drug Safety Personnel
- Post-Marketing
Pharmacovigilance Personnel
The course will be led by one of the following
instructors:
Vaska Tone
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 :
2016102500000000
topics :
- Clinical Research
- Medical Device
- Regulatory Compliance
jobfunctions :
- Clinical Operations & Trial Management
- Clinical Quality Assurance
- Clinical Research Associate
- Quality Control
- Regulatory Affairs
- Study Site Compliance
- Training
series :
- Clinical Trials & Translational Medicine
content Id :
168431
urlAliasnm :
Web-Seminar-Archives/EMA-and-FDA-Inspections--Key-Differences-and-Similarities-October-2016/