VSCR promotes lifelong learning and complies with enhanced European quality standards in education and training for discovery, development and commercialization of medicines.
Written by Heinrich Klech, MD, PhD, founder and managing director of the Vienna School of Clinical Research, Public Health and Medical Education (VSCR)
The pharmaceutical industry needs highly skilled professionals who understand cutting-edge technologies and life sciences disciplines to adequately perform and deliver their research and development (R&D) as well as their commercialization activities. This includes the ability to understand and follow current developments in Health Outcome Research and Health Economy.
The industry also needs to be able to support the continued professional development (CPD) of employees, who often have to re-skill in a rapidly moving business. Uptake of new science in academic teaching is not happening quickly enough. As a result of this, some pharmaceutical companies have individual initiatives to establish training courses to address their needs; others simply relocate to where they have access to the right skills. This is expensive for industry and does not address to the fact that individuals trained in one company often need to be retrained when they move jobs because skills acquired in one setting are not recognized in another.
This problem has been addressed on a European level. The Innovative Medicines Initiative (IMI; http://www.imi.europa.eu/) is a unique and large-scale public–private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA; http://www.efpia.org). IMI ran a €2 billion research programme with the aim to speed up the discovery and development of safer and more effective drugs for patients, and to reinvigorate the biopharmaceutical sector in Europe.
In this context a Cross-Project Task Force on Course Quality convened to address the need for shared quality standards in training for European medicines R&D including Health Outcome Research. This resulted in a position paper reflecting the Task Force’s joint understanding and recommends a shared set of standards to develop a framework for quality assessment of courses.
The position paper (1) shows essential guidelines for shared quality standards which are:
1. University accreditation or an equivalent system for approving, monitoring and reviewing the training offered. An important goal of this is to encourage universities to provide CPD in addition to classical higher education
- a. A system for quality assurance of teaching staff. Although assessing the quality of the curriculum is an important part of quality assurance, it is also vital that the teaching staff have the appropriate skills to teach the curriculum.
- b. Regular review of the quality assurance/quality control process and demonstration that the training is further developed in light of this review. This is important to ensure that quality assurance procedures are not merely a box-checking exercise, but address any concerns that the students, teaching staff or other stakeholders may have, with the goal of continually improving course quality.
2. A set of documented criteria for individual modules, courses or course programmes that include the following:
- a. Defined and transparent admission criteria.
- b. A predefined set of teaching objectives, leading to defined learning outcomes. Learning outcomes are statements of what a learner is expected to know, understand and/or be able to demonstrate after completion of a process of learning. Learning outcomes must be accompanied by appropriate assessment criteria that can be used to judge that the expected learning outcomes have been achieved. Learning outcomes, together with assessment criteria, specify the requirements for the award of credit
- c. The facilities, infrastructure, leadership and competences available for the support of student learning should be adequate, appropriate and up to date for the training offered. This includes, but is not limited to, provision of up-to-date course material.
- d. Assessment of the students’ achievement in accordance with the agreed learning outcomes of the training offered. The most important principle here is that students are awarded their certificate once they have demonstrated that they have improved their skills/knowledge/competence in accordance with the stated learning outcomes.
- e. A system for collecting, assessing and addressing feedback from learners, teachers, technical/administrative staff and programme/course/module managers
- f. Availability of appropriate and updated reference material (e.g. published articles, links, book chapters and scripts)
CPD is the means by which professionals maintain, improve and broaden the knowledge and skills required in their professional lives. It is a conscious updating of professional knowledge and improvement of professional competence throughout an individual’s working life, building on a commitment to being professional, keeping up to date and continuously seeking to improve. It is the key to optimizing career opportunities, both today and for the future.
(1) H.Klech et al: European Journal of Pharmaceutical Sciences 2012; 45: 515-520.
The Vienna School of Clinical Research (VSCR) and the Sigmund Freud University Wien (SFU) are holding international Diploma Programmes on Health Economy, Health Technology Assesement (HTA) and Decision Making for Pricing and Reimbursement. The first module takes place in Vienna from November 15th to 18th. Head lecturers are Keith Tolley, BA, MPhil, Director of Tolley Health Economics, University of York, UK and Lieven Annemans, MSc, PhD Senior Professor of Health Economy, University Ghent, Belgium, past president ISPOR
More information on the course and registration can be found here: https://vscr.at/public-health/
Heinrich Klech, MD, PhD is founder and managing director of the Vienna School of Clinical Research, Public Health and Medical Education (VSCR). As Professor of internal Medicine of the Medical University Vienna, he held several global executive R&D management positions in the pharmaceutical industry and was responsible for postgraduate education in Austria and on European level. He was also board member of the Austrian Akademie der Ärzte.
In 2000 he founded the Vienna School for Clinical Research (VSCR), ). a not-for-profit postgraduate educational institution, which trained and developed more than 7000 scientists from 90 countries in close partnership with 14 international universities. Today, the VSCR is an international Center of Excellence for Clinical Research, Health Economy and accredited postgraduate medical education.