AGAH/EUFEMED Training Course - Regulatory, operations, ethical and quality requirements in today’s early phase clinical trials - Module 3
Mar 5 - Mar 21, 2025 (online and face to face)
This course is accredited as part of the EUFEMED Certificate in Human Pharmacology. The training courses are intended for physicians, biopharmaceutical scientists and healthcare professionals working in early phase clinical research and would also suit investigators intending to fulfill the role of Principal Investigator for First in Human (FIH) trials.
At the end of this course, you will be able to address and apply the ethical, regulatory and quality requirements of early phase clinical trials in your daily work. You will be familiar with the required measures for risk identification, assessment, mitigation and management in the early phase clinical trial activities presented in this course. You will know how to prepare the single dossier documentation and how to interact with the Clinical Trial Information System (CTIS) within the new Clinical Trial Regulation framework. You will understand the organizational and quality requirements when preparing a Phase I unit for inspection readiness.
Case studies and home work will provide the opportunity to discuss and apply the theoretical background provided in the lectures.
Halfday 1: 5 March (online)
Halfday 2: 7 March 2025 (online)
Day 3- 5: 10 - 12 March 2025, on-site (face-to-face in Oberursel/Germany)
Halfday 6: 20 March (online)
Halfday 7: 21 March 2025 (online)
Test: 24 March 2025 (online, activation 5 to 7 pm)
To download the leaflet with more information on the Programme Outline, please click here. Download program as PDF
Registration Information
Accommodation for the face to face part, is not included and must be booked separately by yourself. Please reserve a room yourself within the room contingent at the venue:
99 EUR per night, single room, incl. Breakfast
directly by phone: 0049 6171 500800 or
by email: bookings.frankfurt-oberursel@elaya-hotels.com
Code: “AGAH- Modul 3”
Start your registration here:
Online Registration
