EUFEMED Human Pharmacology Training Course – Certificate/Diploma
EUFEMED is developing a modular training course in Human Pharmacology leading to qualifications at the certificate (15 ECTS) and diploma (30 ECTS) level (ECTS refers to European Credit Transfer and Accumulation System).
The training course is 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.
The course content was derived from and is aligned with the syllabus of the PharmaTrain diploma/Master course in Pharmaceutical Medicine/Medicines Development Sciences. PharmaTrain is a not-for-profit organisation assessing the quality of courses in the biopharmaceutical sector, based on a syllabus jointly developed with the Faculty of Pharmaceutical Medicine, UK and IFAPP (International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine).
EUFEMED has drawn together a training faculty of experienced course instructors from its member associations in Belgium, the Czech Republic, France, Germany, the Netherlands and the United Kingdom and from invited guest lecturers.
The content in the PharmaTrain syllabus was evaluated for applicability and relevance to training in Human Pharmacology and gaps were identified and closed. Six overarching human pharmacology training modules (of 5 to 7 days duration each) were defined with the option to develop a seventh module focusing on biologicals and advanced therapies:
- Module 1: Introductory Course in Exploratory Medicines Development
- Module 2: Pharmacokinetics (PK) / Pharmacodynamics (PD) / PK+PD / Biomarkers
- Module 3: Regulatory Issues / Ethics / GxP / Quality Assurance
- Module 4: Study Design / Exploratory Development Plan / Clinical Operations / Data Management / Statistics
- Module 5: Non-clinical safety / Clinical Safety / Pharmacovigilance
- Module 6: Phase I Principal Investigator Training (non-oncology drugs)
- Module 7: Biologicals and Advanced Therapies (TBD)
The EUFEMED syllabus maintains close alignment with the PharmaTrain course in order to support the goal of recognition by PharmaTrain. This is intended to ensure European acceptance of the EUFEMED human pharmacology course.
Participants will be free to choose the modules that they are interested in. There will be some stipulations on the prerequisites for certain modules.
Three modules are required for a EUFEMED Certificate and six modules for a EUFEMED Diploma in Human Pharmacology.
Each module will consist of between 5 to 7 days of lectures and exercises:
- Pre-course reading will be required
- Each module will include the conduct of case studies and team exercises and will conclude with a multiple-choice examination
- Post-course assignments will reinforce the learning process
Modules will be taught from easily accessible teaching venues in major European cities in Belgium, France, Germany and the United Kingdom. Watch this space as more detailed practical information will soon become available about the EUFEMED Human Pharmacology course.