Am2P: A New Accredited Academic Training Program in Pharmacovigilance and Pharmacoepidemiology Designed for US, Canadian and Caribbean Healthcare Professionals: An International Journal of Medical Toxicology and Drug Experience

ABSTRACT

Introduction: Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem. Objective: In November 2021, the North American Society of Pharmacovigilance (NASoP), a Chapter of the International Society of Pharmacovigilance (ISoP), launched PV courses for the education of North American stakeholders, in collaboration with Eu2P academic institutions. Methods: The Am2P program (Am2P) follows WHO-ISoP Core Elements of a Comprehensive Modular Curriculum and subscribes to the Innovative Medicines Initiative (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. Convenient online education in PV supports the mission of ISoP to foster PV scientifically and educationally and enhance the safe and proper use of medicines worldwide. Am2P was designed by experienced PV experts from multiple institutions within NASoP, in partnership with Eu2P instructors, to comprise North America-focused online courses that benefit from existing Eu2P material, education technology, and academic accreditation. Results: Am2P offers two academic options the Certificate degree and the Short Course certificate of achievement in PV. Four modular course programs are available on the Am2P website (https//www. am2p-courses.com) providing education on core and specialized PV topics with a focus on North America Basic Pharmacovigilance (PV) & PV regulations;PV for Biologics;External databases/Real World Data/Real World Evidence;Benefit-Risk assessment. Program approval is ensured by the Eu2P Executive Board including academic representatives of the 6 Eu2P degree-awarding universities. Am2P and Eu2P Certificate Courses hold the same academic value. A regular Certificate course involves 75h student workload over three months, recognized as 3 ECTS (European-Credit Transfer and Accumulation System) credits, equivalent to 1.5 American credits. Am2P Short Courses are bite-sized courses to provide or reinforce solid, current knowledge in PV focused on North America. Conclusion: Am2P is a partnership between NASoP and Eu2P to build a set of North America-focused online courses offered in PV. Am2P offers accredited PV training of the highest standard, focused on North America, as an extension of the Eu2P program. Online PV training addresses needs of new entrants to PV, and seasoned personnel.