Training - Good clinical practice
31/05/2017 13:30 to 31/05/2017 17:30 (Europe/Luxembourg)
Luxembourg,
Luxembourg
Luxembourg,
Luxembourg
COurse content
In the framework of the Luxclin conference, CIEC organizes an interactive and certified training in “Good Clinical Practice”, focusing on updated ICH GCP guidelines (E6 R2 Update).
agenda
| 13:30 |
Welcome and Introduction |
| 13:40 | What is new in the ICH-GCP Guideline with Integrated Addendum E6 (R2)? (Ingrid Klingmann) |
| 14:00 | Sponsor responsibility: Focus on quality management (Ingrid Klingmann) |
| 14:45 | Break |
| 15:15 |
Practical aspects of a risk-based monitoring approach (Ingrid Klingmann) |
| 16:00 | Site management with validated computerized systems in Europe and US (CRF part 11) (Lisbeth Tofte) |
| 17:00 | Final test |
| 17.30 | Review and discussion of correct answers (Ingrid Klingmann and Lisbeth Tofte) |
| 17:45 | Closing remarks |
CONFIRMED SPEAKER
DR INGRID KLINGMANN
Chairman, European Forum for Good Clinical Practice (EFGCP), Belgium
Lisbeth Tofte
Drug Safety Consult, member of EFGCP, Denmark