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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.
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.
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 11 December 2014 | By Louise Zornoza,
This content is provided by RegLink News, publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members.
India’s Central Drugs Standards Control Organisation (CDSCO) is soliciting feedback on the Ministry of Health and Welfare's plan to upgrade the country’s regulatory system at both national and state levels over the next three years.
The goal of the upgrade is to “facilitate expeditious consideration and faster decision making and testing of medical products wherever required and serve the objective of the quality, safety and efficacy of drugs and other medical and cosmetics products.”
On both state and national levels, the plan calls for:
The plan also proposes the establishment of a Training Academy and implementation of an e-Governance mechanism and networking of CDSCO and State Drugs Control Departments.
Comments on the proposed plan can be submitted until December 22, 2014.
Tags: RegLink, Regulatory Capacity
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