This training is intended for physicians, biopharmaceutical scientists and healthcare professionals working in exploratory medicines development research as well as investigators and research staff performing early phase clinical 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 a home work will provide the opportunity to discuss and apply the theoretical background provided in the lectures.

Schedule

Halfday 1:        5 March and
Halfday 2:        7 March 2025 (2 half days online)
Day 3- 5:         10 - 12 March 2025, On-site (face-to-face, 3 full days in Oberursel/Germany)
Halfday 6:       20 March and
Halfday 7:       21 March 2025 (2 half days online)
Test:               24 March 2025 (Activation 5 to 7 pm)

This AGAH training course is part of a European Initiative fostering knowledge transfer to those interested in human pharmacology and translational medicine. The German AGAH, the Association Francaise de Pharmacologie Translationelle (AFPT), and the Belgian Healixia in cooperation with the European Federation for Exploratory Medicines Development (EUFEMED) and its further Member Societies have developed a modular training in human pharmacology and translational medicine, leading to a qualification at the certificate level.

Four overarching training modules (of 5 to 7 days duration each) were defined. Out of these, 3 modules are required to apply for a EUFEMED Certificate in Human Pharmacology. Participants are free to choose the modules that they are interested:

• Modul Introductory Course in Exploratory Medicines Development (Parts I and II) (organized by AGAH)
• Module Pharmacokinetics (PK) / Pharmacodynamics (PD) / PK+PD / Biomarkers (organised by Healixia)
• Module  Regulatory Issues / Operations/ Ethics / GxP / Quality Assurance (organised by AGAH)
• Module Non-clinical safety / Clinical Safety / Pharmacovigilance (organized by AFPT)

EUFEMED has drawn together a training faculty of experienced instructors from its member associations and from invited guest lecturers.

The content of the Human Pharmacology Training was derived from and is aligned with the syllabus of the PharmaTrain diploma / MSc in Pharmaceutical Medicine / Medicines Development Sciences. PharmaTrain is a not-for-profit organisation assessing the quality of courses in the biopharmaceutical sector. The PharmaTrain syllabus was evaluated and adjusted for applicability and relevance to training in human pharmacology.

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