PharmaTrain Recognition

PharmaTrain Federation is an accrediting and certifying not-for-profit-organisation. It has established and is further developing top-quality Global Shared Standards for Education and Training in Medicines Development.

PharmaTrain Recognised Courses

The PharmaTrain course concepts have been developed by university-based course providers and pharmaceutical industry experts to meet the industry’s needs and are outcomes-based to optimise the learning process for the student. In addition, PharmaTrain has developed a set of quality standards for ongoing quality assurance and created the accreditation infrastructure for PharmaTrain recognition as “PharmaTrain Centre” or “PharmaTrain Centre of Excellence” for course providers offering diploma or master programmes, CPD Modules and investigator training courses and fulfil the shared standards. Training Centres offering Diploma Courses, Master Programmes and CPD Modules and which fulfil the Shared Standards can apply for formal recognition by PharmaTrain. The recognition process follows a defined procedure.

What is a PharmaTrain recognised Course ?

PharmaTrain Courses
Courses in PharmaTrain are defined as follows:

The PharmaTrain course principles are well described in the Guidelines - 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
30 ECTS, 6 x 5 ECTS modules. The entire syllabus is covered. It has the following Curriculum:


Introductory course
Drug discovery & development planning   
Non-clinical testing, pharmaceutical & early clinical development   
Exploratory & confirmatory clinical development   
Clinical trials   
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. 
ELM 10
ELM 11
ELM 12
ELM 13
ELM 14
ELM 15
ELM 16
ELM 17
ELM 18
ELM 19
ELM 20
ELM 21
ELM 22
ELM 23
ELM 24
ELM 25
ELM 26
Medicines Regulation
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
Advanced Pharmacokinetics
Pricing & Reimbursement Strategies
Health Economics
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),

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

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)