Interactive Training in Applied Good Clinical Practice (GCP) for Investigators & Site Personnel

04/03/2020 13:00 to 04/03/2020 17:30 (Europe/Luxembourg)

Luxembourg, Luxembourg

Performance of clinical trials according to Good Clinical Practice (GCP) principles has been introduced as a European regulatory requirement by the Clinical Trial Directive 2001/20/EC. Strict adherence to this standard ensures patient protection and reliable data. It is the basis for acceptance of publications and for patients’ access to new treatments. This standard has implications for all stakeholders and processes in clinical trials. However, despite overall commitment and best intentions to apply to these requirements, monitoring, audits and inspections regularly find deficiencies of different levels of severity.

In this interactive half-day workshop, current experience and requirements of GCP-conform set-up and performance of clinical trials will be presented, their practical implications and examples discussed and pragmatic solutions for your daily practice elaborated.

PROGRAMME

13:00 | Welcome & Introduction

13:00 | Good Clinical (Research) Practice in European legislation

14:30 Set-up of a clinical trial at the investigative site

15:00 | GCP compliance in document management

15:30 | Coffee Break

15:50 | Optimising the informed consent process

16:10 | Critical elements of conducting clinical trials

16:45 | Reliable safety management at the site

17:10 | Final Test and discussion

17:30 | End of the Training

REGISTRATION

As the number of seats is limited, we will accept registrations on a first come first served basis.


Fees

Category 1
​LIH / IBBL / Students / LCSB / National hospitals / National healthcare professionals / Researchers / PI / National academia​€ 0
Category 2
International academia€ 100
Category 3
private companies€ 200




Organised by : 

Clinical and Epidemiological Investigation Center

 In collaboration with :


Speaker

Ingrid Klingmann

MD, PhD, FFPM, FBCPM

Expert in Drug Development Planning and Site Management Support, Pharmaplex bvba, Brussels, Belgium & Chairman of the Board of European Forum for Good Clinical Practice (EFGCP)


Information

When: Wednesday 04 March 2020

Where: Centre Hospitalier Luxemborug (CHL)

Amphithéâtre
4, rue Barblé
L-1210 Luxembourg

Contact: tania.zamboni@lih.lu





Ticket Type End of Registration Price Quantity
Category 1 - GCP Training for Investigators & Site Personnel
26/02/2020 Free
Category 2 - GCP Training for Investigators & Site Personnel
26/02/2020 100.00 € 100.0 EUR
Category 3 - GCP Training for Investigators & Site Personnel
26/02/2020 200.00 € 200.0 EUR

Where

4, rue Barblé
    Luxembourg 1210
    Luxembourg

When

From 04/03/2020 13:00
To 04/03/2020 17:30

Contact

Luxembourg Institute of Health
+352 26 970
+352 26 970 719
odoo@lih.lu