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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.
Share your knowledge and expertise with your regulatory peers by submitting an in-depth, evidence-based article focusing on key areas and emerging issues in the global regulatory landscape.
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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.
Registration is now open for RAPS Convergence 2021! Gather with the regulatory community 12-15 September for four days of learning, engagement, and excitement.
Keep the sparks coming! Delegates of the conference have access to on-demand content until the end of October 2021.
This updated edition is a great reference for anyone working in multinational product development and marketing.
Regipedia is an interactive resource created to benefit RAPS members with 24/7 access to more than 2,300 regulatory terms.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
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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