SMD Programme

The Specialist in Medicines Development (SMD) concept,
developped jointly by PharmaTrain and IMI-Train

IMI Train & SMD Programme

The Specialist in Medicines Development (SMD) is a competency-based, workplace-centred education and training certification programme in Medicines Development, comprising a knowledge base covering the PharmaTrain Syllabus for Medicines Development Science, delivered and assessed through modular curricula, and the acquisition and demonstration of competencies for medicines development across seven domains of the competency curriculum. Participants in this mentored, vocational programme acquire knowledge and competencies within a framework of assessment, appraisal and annual review of progress and achievement. On completion, participants receive the SMD Certificate from the PharmaTrain Certification Board (PCB).

PharmaTrain, SMD Final Report for IMI-Train
SMD Curriculum Path & Certification Process

SMD Concept & Objectives

Currently, academically-qualified (in medicine or life sciences) people working in medicines development are trained on the job, undertake continuing professional development (CPD), and participate in university training courses to achieve a secondary diploma and/or master degree. Both tracks will lead to an individual acquiring a certain array of competencies across multiple domains. So far, there is no qualification / degree / award available in most countries which certifies this described background or achievement, and the PharmaTrain SMD Certification concept & programme aims to fill this gap.

SMD Certification

On completion, participants achieve SMD certification from the Global PharmaTrain Certification Board (gPCB) (Members from PharmaTrain and IFAPP), based on the gPCB’s thorough review of the trainee’s documented post-graduate education and competence-development achievements.

SMD is renewable after participation in a 5-year CPD programme


See below the 5 precondition to be eligible for the SMD Programme
  • Completed Diploma or Master course in Pharmaceutical Medicine / Medicines Development (or equivalent) from a PharmaTrain recognised course or a course approved by the gPCB
  • Competencies acquired in workplaces approved for SMD (Pharma Company, CRO, Competent Authority, Academia), supported by Mentor at workplace, supervised and appraised by PharmaTrain Regional Specialist Advisor
  • Demonstrated performance in at least 3 Domains of competence curriculum & evidence for assessed cognitive competency acquired in additional Modules or Courses to cover the remaining of the 7 Domains
  • Commitment to CPD with 250 working hours demonstrated learning in a 5-year period
  • gPCB decides on the award based on candidate’s training record, Mentor Report, annual appraisals