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
Would you like to register for this event?
Please contact Tania Zamboni: tania.zamboni@lih.lu.
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
