🇬🇧 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

Registration & information: tania.zamboni@lih.lu