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 on the description of Shared Standards and belong to the following 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.
Modular Structure of PharmaTrain Diploma (Base) Courses, Extension and Integrated Master Programmes (Master of Medicines Development, MMD)
Definition of a Module
A PharmaTrain Module (5 ECTS) is characterised as follows:
- 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.
Diploma (Base) Course, DIMD: 30 ECTS, 6 x 5 ECTS modules. The entire syllabus is covered. It has the following Curriculum:
| Module 1a | Introductory course |
| Module 1b | Drug discovery & development planning |
| Module 2 | Non-clinical testing, pharmaceutical & early clinical development |
| Module 3 | Exploratory & confirmatory clinical development |
| Module 4 | Clinical trials |
| Module 5 | Regulatory affairs, drug safety & pharmacovigilance |
| Module 6 | 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)
or
Extension Master Programme 30 ECTS Base (Diploma) Course + 4 mandatory Extension Modules + 2 modules taken from a list of recommended courses (electives)
The four mandatory Extension Modules have the following topics:
Ext 1: Health Economics
Ext 2: Drug Safety, Pharmacoepidemiology, Pharmacovigilance, Risk Management
Ext 3: Biologicals and Advanced Therapies
Ext 4: Vulnerable Diseases and Clinical Trial Practices
Thesis 15-20.000 words – research / literature review based (dependant on the University providing the course)
Electives
An Elective is defined as a module which can be used to complete the Masters Degree i.e. in addition to the Extension Modules (Extension Master) or as part of the Integrated Masters Programme. PharmaTrain will work on a defined list of electives which are well characterized in terms of learning outcomes and content. Course providers may choose electives for recommendation.
CPD Platform
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.
Please note that in spring 2012 the PharmaTrain Courses and Modules will be taken from the “On-Course” data base developed by the partner project “EMTRAIN”, one of the other five IMI JU “Education & Training (E&T) Projects. On-Course will be the most comprehensive biomedical and medicines research and development postgraduate course portal in Europe.
Further programmes in PharmaTrain are under development:
A European Master of Regulatory Affairs (MRA)
A course for Clinical Investigators
