Syllabus, Modules, Curriculum, Learning Outcomes, Electives, e-Products in Medicines Development


The PharmaTrain Syllabus: a list of topics comprising a subject, discipline or specialty field.

Based on the IFAPP Syllabus for Pharmaceutical Medicine PharmaTrain has extended and adapted the syllabus to form the PharmaTrain Syllabus, V1.0, 2010. This Syllabus has been transferred into the Diploma (Base) Course and Extension Modules (section 3) and the modules for the Integrated Master programme.

The Syllabus contains 183 topics and 14 sections:
  1. SECTION    Discovery of Medicines
  2. SECTION    Development of Medicines: Planning
  3. SECTION    Non-Clinical Testing
  4. SECTION    Pharmaceutical Development
  5. SECTION    Exploratory Development (Molecule to Proof-of-Concept)
  6. SECTION    Confirmatory Development: Strategies
  7. SECTION    Clinical Trials
  8. SECTION    Ethics and Legal Issues
  9. SECTION    Data Management and Statistics
  10. SECTION    Regulatory Affairs
  11. SECTION    Drug Safety, Pharmacovigilance and Pharmacoepidemiology
  12. SECTION    Information, Promotion and Education
  13. SECTION    Economics of Healthcare
  14. SECTION    Therapeutics 

The Curriculum of Diploma (Base) Course and Master Programmes
  • The Curriculum is the guideline to transfer the content of the Syllabus into the modular structure and is a statement of the aims and objectives, content, experiences, outcomes and processes of a programme, including a description of the structure and expected methods of learning, teaching, feedback and supervision. The curriculum sets out what knowledge, skills, attitudes and behaviours the trainee will achieve (see Learning Outcomes, below).
  • Diploma (Base) Course, DIMD: 30 ECTS, 6 x 5 ECTS modules, 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 and is designed
  • Master in Medicines Development, MMD: 60+ ECTS, 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 + 6 modules taken from a list of recommended courses (Electives)
    The Extension Modules have the following topics:

Learning Outcomes
Learning Outcomes are statements of what a student is expected to know, understand and/or be able to demonstrate after completion of a process of learning. These are the guiding principles for the development of the curriculum and each module, enabling mutual recognition between different institutions across Europe.

The Programme Learning Outcomes have been defined as follows:
 
1. Programme Learning Outcomes for 30 ECTS Diploma (Base) Course
On successful completion of this course in pharmaceutical medicine students should be able to demonstrate an understanding / knowledge of the following:
  • the principal steps in drug discovery
  • the complete development plan (pharmaceutical, non-clinical and clinical) according to the proposed therapeutic indication
  • the pertinent issues involved in the undertaking of clinical research
  • the regulation of medicines in the various global markets
  • the management of drug safety issues pre-and post marketing authorisation
  • development and review of product-related information to ensure adherence to ethical and legal provisions
  • the principles of health economics and their application in the development and marketing of medicines
  • the management of all lifecycle activities (regulatory and marketing) of a medicine 

2. Programme Learning Outcomes for the 60 ECTS Master Programme (Extension and Integrated Master Programmes)
On successful completion of this course in pharmaceutical medicine students should be able to:
  • Outline and critically appraise the principal steps in drug discovery
  • Explain the rationale for the complete development plan (pharmaceutical, pre-clinical and clinical) according to the proposed therapeutic indication
  • Critically review the issues (including legal, ethical and clinical) involved in the undertaking of clinical research
  • Appraise and compare the regulation of medicines in the various global markets
  • Assess and compare the management of drug safety issues pre-and post marketing authorisation
  • Develop and critically appraise product-related information to ensure adherence to ethical and legal provisions
  • Explain the principles of health economics and discuss their application in the development and marketing of medicines
  • Critically review and interpret the literature relating to drug research and usage
  • Demonstrate competence in the management of all lifecycle activities (regulatory and marketing) of a medicine