Modular Course Structure
Summary of Shared Standards and definitions
please find a Glossary here
Bologna principles and ECTS System
PharmaTrain is fully based on the Bologna process, which is well established in Europe. PharmaTrain uses 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 electives, extension modules and stand-alone modules provided by PharmaTrain to facilitate lifelong learning. In addition, PharmaTrain will identify and recommend high quality CPD modules from a variety of course providers. The CPD courses can all be found on www.pharmtrain.eu.
Please note that in 2012 the PharmaTrain courses and modules will also be available in the on-course catalogue 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.
Current Situation in PharmaTrain (see Fig. below):
Extension master programme: five universities provide a postgraduate diploma consisting of 6 base modules including an introductory module (30 ECTS, 1st tier). By completing an additional six Extension / elective modules and a master thesis a successful student will achieve a masters’ degree (60+ ECTS, 2nd tier).
Integrated master programme: eight universities and colleges provide a master programme with a continuity of modules and a master thesis (60+ ECTS, 2nd tier).
Modular structure: most of the 14 institutions are constructing comparable modules aligned with the Bologna process with learning outcomes which are assessed to facilitate pan-European mobility.
Fig.:This ‘ellipsogram’ depicts the 6 Diploma (Base) Course Modules and the additional 6 ‘Extension’ Modules of which two are electives (from the CPD platform) for the MMD (Extension Master Programme)
