Policy and procedures for quality assurance
The Am2P quality assurance is ensured by the application of Eu2P Academic Partners policies and procedures for quality assurance.
Approval, monitoring and periodic review of programmes and awards
The Am2P program is designed by the NASoP group to fit the North American pharmacovigilance education needs. The program also complies with the WHO-ISoP Core Elements of a Comprehensive Modular Curriculum and subscribes to the IMI Education and Training quality standards jointly developed by Eu2P and other IMI Education and Training projects to foster quality in lifelong learning and continuing professional development.
The Am2P program approval is ensured by the Eu2P Executive Board including academic representatives of the 6 Eu2P degree-awarding universities.
The program monitoring and periodic reviews are conducted by the NASoP group and the University of Bordeaux under the supervision of the Eu2P Executive Board.
Assessment of trainees
Trainees are assessed in the light of expected learning outcomes, upon clear assessment modalities (marking, retakes, complaint criteria and policies).
An independent Eu2P Programme External Examiner is appointed by the University of Hertfordshire to have oversight of the whole programme assessment and to ensure its fairness & equity.
Consistent application of assessment rules and validation are ensured by the Eu2P Executive Board.
Quality assurance of teaching staff
The NASoP group selects academics as well as major and highly skilled professionals belonging to pharmaceutical companies and regulatory agencies to design and deliver the program.
The NASoP group experts follow the online teaching quality standards and guidance agreed and provided by the Eu2P Consortium and benefit from the Eu2P Office expertise and support in online education.
Learning resources and trainee support
Online education tools and resources follow the delivery standards and best practices adopted by the Eu2P consortium. Learning resources are updated according to periodic program review action plans and according to technical standards
evolutions to improve content accessibility, readability, compliance and performance with software and reading devices.
Online trainees benefit from the online support provided by the Eu2P Office.
These learning tools, resources and support have track records of trainee satisfaction since 2011 (in the light of anonymous trainees feedback, former trainee testimonials, innovative education award)
Feedback from students on the program, the training material & the delivery quality is also collected anonymously through a report form to be completed on conclusion of each course.
These student feedbacks are reviewed by the Eu2P Executive Board to help improve the course program, resources, support, tools and teaching quality. Likewise, any unusual technical incident, or unexpected course examination failure rate are analysed to possibly improve the program and expected learning performances.
In addition, former course participants and their organizations are also regularly contacted to gather suggestions and appraisals relating to the programme implementation.
Course description and learning outcomes updates are ensured when applicable upon periodic review processes and made public on the Eu2P and Am2P websites.
Courses statistics about students' profile, localization, and success are regularly conducted and updated on the Eu2P website*.
Former student testimonials are also published on the website to help new-comers appraise the program and course quality*.*: Eu2P Quality indicators.
External quality assurance
Am2P/Eu2P Quality assurance is being externally audited through regular (re) accreditation of the Eu2P Master programme at the local and/or national levels of the Eu2P awarding universities.
In addition, the Eu2P education program also successfully passed an education and training project audit by the Innovative Medicines Initiative in 2012 and a quality assessment audit by the PharmaTrain Federation in 2016, that led to a PharmaTrain Centre Recognition award.
As part of the Eu2P Higher Education program, the Am2P program shares the Higher Education quality guidelines and standard operating procedures that cover the main quality items described in the ENQA report on Standards and Guidelines for Quality Assurance in the European Higher Education Area. In particular, Am2P applies the Université of Bordeaux institutional quality assurance protocols.