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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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One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
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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.
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This year, our European regulatory community will converge online with a fully virtual program that will allow attendees to experience Euro Convergence live online from the safety and comfort of their homes.
RAPS' “how to” guide to developing a comprehensive global regulatory strategy for all types of medical devices. Updated September 2020.
The last exam window of 2020 is currently open. Register by 8 October to take the RAC exam this autumn.
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Posted 22 October 2014 | By Louise Zornoza,
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India’s Central Drugs Standard Control Organization (CDSCO) has announced the formation of a new task force to undertake a comprehensive review of the existing processes, procedures, forms and licenses used by the agency with the purpose of making them simpler and more user friendly.
The task force includes four former CDSCO officials and the agency’s current Deputy Drugs Controller, and the announcement also asks five industry trade associations to submit nominations for industry representation.
The announcement gives the task force three months from the date of its first meeting to accomplish its mission, and emphasizes that all revisions must be compliant with the agency’s recently approved online system.
CDSCO Announcement
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