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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.
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.
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 01 September 2008
Regulatory leadership today is linked as never before to the management of global risk-specifically, global business risk.
This may be counterintuitive to those who have regarded regulatory affairs as the quasi-academic "documentation side" of drug development. But, in fact, the regulatory function in industry today is an increasingly critical platform for the management of business risk. The events and developments of the last 10 years (medical product failures, fallow pipelines, expiring patents, emergence of new and attractive but poorly understood markets) have created vast quantities of risks for the biopharmaceutical and medical device industries in the foreseeable future. Companies find themselves trying to emerge unscathed from this down-cycle, and in some cases possibly fighting for survival. And, many of these risks are related to regulated activities.
Regulatory Focus newsletters
All the biggest regulatory news and happenings.