Face-to-face Training on 07 June 2023
Novotel Kirchberg: Quartier Européen Nord
(6 Rue du Fort Niedergruenewald ¦ L-2226 Luxembourg)
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
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)
PhD, Luxembourg Institute of Health (LIH), Head of Unit CIEC & CPMO, Clinical and Epidemiological Investigation Center
PhD, Luxembourg Institute of Health (LIH), Clinical Research Coordinator Quality & Regulatory, Clinical and Epidemiological Investigation Center
Registration & information: tania.zamboni@lih.lu
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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