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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
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Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Convergence 2020 has come and gone, but you can still access recorded sessions, which are available to attendees until 31 December 2020.
Replay the moments of Euro Convergence 2020. Recorded sessions are available to attendees until 31 January 2020.
RAPS' “how to” guide to developing a comprehensive global regulatory strategy for all types of medical devices. Updated September 2020.
From self-assessments to help you identify your strengths and areas to focus on to reference books and online courses that will help you fill in the gaps in your regulatory knowledge, RAPS has the resources to help you prepare for the RAC exam.
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Posted 01 September 2011
The World Health Organization (WHO) defines "pharmacovigilance" as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.1
Title IX of Directive 2001/83/EC relating to medicinal products for human use (Articles 101 to 108) covers issues related to pharmacovigilance. According to the directive, the objective of a functioning pharmacovigilance system should be to safeguard public health without impeding the free movement of safe medicinal products within the EU.2
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