Courses in PharmaTrain are defined as follows:
- Courses are composed of several modules (definition below).
- part of the PharmaTrain Syllabus incl. defined Learning Outcomes
- fulfils the 9 Cross Project course quality criteria
- characterized by Learning Objectives leading to Learning Outcomes
- defined ECTS points
The PharmaTrain course principles are well described in the Shared Standards
and follow the below described logic:
Bologna principles and ECTS System
PharmaTrain is fully based on the Bologna process, which is well established in Europe. PharmaTrain relies on the European Credit Transfer and Accumulation System, ECTS: 1 ECTS = 25-30 student investment hours.
Definition of a Module
A PharmaTrain Module (5 ECTS) is characterised as follows:
Diploma (Base) Course, DMD
- Usual duration 4 days face-to-face course at a university centre (2 ECTS)
- Pre-Course work and (e-)preparation (1 ECTS)
- Post-Course work: research, reading, assignments (2 ECTS)
- all modules have assessments at the end. The type of assesments varies.
30 ECTS, 6 x 5 ECTS modules. The entire syllabus is covered. It has the following Curriculum:
Drug discovery & development planning
Non-clinical testing, pharmaceutical & early clinical development
Exploratory & confirmatory clinical development
Regulatory affairs, drug safety & pharmacovigilance
Healthcare marketplace & Economics of healthcare
An Introductory ‘Module One’ (two of the four days of module one) will contain the core subjects of the PharmaTrain Syllabus, covering in a standardised format the context for the more detailed modules to follow. It is adopted by all PharmaTrain programmes.
Master in Medicines Development, MMD
60+ECTS. The entire syllabus is covered in 12 modules either as:
Integrated Master Programme
12 modules, no exit at 30 ECTS, 10 modules are mandatory, 2 modules can be taken from a list of recommended courses (Electives)
Extension Master Programme
30 ECTS Base (Diploma) Course + 6 modules taken from a list of recommended courses (Electives)
The Extension Modules have the following topics:
An Elective Module (ELM) is defined as a module which can be used to complete the Masters Degree. PharmaTrain has elaborated a list of 26 ELMs which are well characterized in terms of learning outcomes and content.
Generic & Biosimilar Medicinal Products
Project Management in Medicines Development
Biomarkers and Surrogate Endpoints
Medicines Development for Rare Diseases
Medicines Development in Children
Medicines Development in a Geriatric Population
Practical Approach to Ethical & Legal Aspects of CTs
Systematic Review and Meta-Analysis
Pregnancy and Medications
Principles & Practices of Medical Device Development
Drug Discovery Pharmacology
Model-Based Medicines Development
Statistics and Data Management
Pricing & Reimbursement Strategies
Drug Safety: Pharmacoepidemiology, Pharmacovigilance and Risk management
Biological and Advanced Therapies
Clinical Development Strategy & Trial Management for Medicines for Vulnerable Populations
Modern Development of Oncological Treatments
Risk Management in Clinical Trials
Medical Statistics and Data Management
Clinical Research Methodology
Advanced Pharmacokinetics (with Biostatistics)
Pharmacoeconomics and Medical Information
15-20.000 words – research/literature review based (dependant on the University providing the course)
What is important for me as a trainee?
After having selected the Master Programme of one of the PharmaTrain recognised University Course Providers choose which of the ELMs would fit your personal interests (list below),
- check if your Course Provider is offering these ELMs
- if not, select the PharmaTrain recognised Centre(s) that offer these ELMs and fit your traveling possibilities.
- Even if generally accepted ask for a written confirmation that your University is accepting these specific ELMs as part of your Master programme.
The PharmaTrain CPD-Platform for Continuing Professional Development (CPD) includes elective and extension modules and stand-alone modules provided by PharmaTrain to facilitate lifelong learning. CPD modules are provided by universities but also from Learned Societies within PharmaTrain. CPD platform is available with approx. 100 products provided by the PharmaTrain partners on www.pharmtrain.eu
The PharmaTrain Courses and Modules are listed in the “on-course
” data base, developed in the framework of the IMI project “EMTRAIN
”. On-course is the most comprehensive biomedical and medicines research and development postgraduate courses portal in Europe.
Further programmes in PharmaTrain
A European Master of Regulatory Affairs (MRA)
A Clinical Investigator Training Certification (CLIC) concept including an e-learning course (eClic) http://clic.biomedtrain.eu/cms/