🇬🇧 Interactive GCP Refresher Training » Luxembourg Institute of Health
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🇬🇧 Interactive GCP Refresher Training

Understanding and Enabling Clinical Research in Luxembourg

Face-to-face Training on 07 June 2023

  • Training: 1pm – 5pm
  • Final Test: 5pm – 5.30pm

Novotel Kirchberg: Quartier Européen Nord
(6 Rue du Fort Niedergruenewald ¦ L-2226 Luxembourg)

Important information

  • GCP certificate is required for staff planning or conducting clinical trials with human participants
  • Your GCP certificate is valid for 2 years
  • GCP certificate obtained after attending the training & passing the test at the end. Otherwise certificate of attendance

Agenda

13:00 – Welcome and Introductions

13:10 – Introduction on conditions for different types of studies falling under the EU Regulation 536/2014, the “Clinical Trial Regulation” for medicinal products, Q&A

13:55 – Introduction on conditions for studies falling under the EU Regulation 2017/745, the “Medical Device Regulation”, Q&A

14:20 – Introduction on conditions for studies falling under the EU Regulation 2017/746, the “In vitro Diagnostics Regulation”, Q&A

14:40 – The national regulatory conditions and hospital law in Luxemburg for studies not falling under any of the EU Regulations, Q&A

15:20 – Coffee Break

15:50 – Options for sponsorship and co-sponsorship in the new regulatory framework for clinical researchers in Luxemburg, Q&A

16:05 – Funding options on European and national level, Q&A

16:35 – Open Forum Discussion

16:45 – MCQ Test

17:30 – End of Training


Trainers

  • Ingrid
    Klingmann

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

  • Manon
    Gantenbein

PhD, Luxembourg Institute of Health (LIH), Head of Unit CIEC & CPMO, Clinical and Epidemiological Investigation Center

  • Laetitia
    Garcia

PhD, Luxembourg Institute of Health (LIH), Clinical Research Coordinator Quality & Regulatory, Clinical and Epidemiological Investigation Center

Registration & information: tania.zamboni@lih.lu

Pricing

C1: FREE
LIH | IBBL | Students | LCSB | National Hospitals | National Healthcare Professionals | Researchers | PI | National Academia

C2: 100 €
International academia

C3: 200 €
Private companies

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