Training - Good clinical practice

31/05/2017 13:30 to 31/05/2017 17:30 (Europe/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

Odoo - Sample 2 for three columns

DR INGRID KLINGMANN

Chairman, European Forum for Good Clinical Practice (EFGCP), Belgium

Odoo - Sample 2 for three columns

Lisbeth Tofte

Drug Safety Consult, member of EFGCP, Denmark

Where

4, rue Barblé
    Luxembourg 1210
    Luxembourg

When

From 31/05/2017 13:30
To 31/05/2017 17:30

Contact

Luxembourg Institute of Health
odoo@lih.lu