EUFEMED course: Regulatory, operations, ethical and quality requirements in today's early phase clinical trials
The German Association of Human Pharmacology (AGAH e.V.), the Association Francaise de Pharmacologie Translationelle (AFPT) in cooperation with the European Federation for Exploratory Medicines Development (EUFEMED) and its further Member Societies are developing a modular training course in Human Pharmacology, leading to qualifications at the certificate and diploma levels. 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 fulfil the role of Principal Investigator for First in Human (FIH) trials.
Currently, 3 modules are available:
Module 1: Introductory Course in Exploratory Medicines Development
Module 2: Non-clinical safety / Clinical safety / Pharmacovigilance
Module 3: Regulatory Issues / Ethics / GxP / Quality Assurance
Module 3 information
Day 1: 29 November 2024, Online
Day 2- 4: 2- 4 December 2024, On-site (face-to-face)
Day 5: 9 December 2024, Online
The course content 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. EUFEMED has drawn together a training faculty of experienced course instructors from its member associations and from invited guest lecturers.