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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.
Resources, news and special offers to support you and your professional development during this difficult time.
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.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
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.
Download your copy of the new events calendar and see all the online workshops, conferences, RAC exams and European online workshops RAPS has planned for 2021 at a glance.
An invaluable resource for any professional engaged in designing, composing, compiling, or commenting on regulatory documentation
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.
The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move across top level links and expand / close menus in sub levels. Up and Down arrows will open main level menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab will move on to the next part of the site rather than go through menu items.
Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products.
We are the only source of timely, quality regulatory news, information and analysis that is fully dedicated to covering regulatory issues associated with healthcare products and the regulatory profession. From guidance documents, regulations, rules and international guidelines to legislation, enforcement actions, legal decisions, business trends and more, Regulatory Focus covers everything the regulatory professional needs to know.
With the contributions from our network of subject matter experts, regulators, members and staff, Regulatory Focus keeps you informed about the changing regulatory landscape through daily intelligence gathering, in-depth articles and analysis.
At Regulatory Focus, we strive to make regulatory content available to you in whatever form is most convenient for you.
Want more? Regulatory Focus also has in-depth analysis of and perspectives on regulatory topics written by regulatory professionals exclusively for RAPS members. Members also enjoy access to RAPS’ Regulatory Exchange, a social network exclusively for regulatory professionals. Become a RAPS member to enjoy these and other benefits, and find out why Focus was voted the most valuable benefit of RAPS membership.
The Regulatory Focus team includes Kari Oakes, Managing Editor; Renée Matthews, Senior Editor (Features); and Michael Mezher, Senior Editor (News). The team is led by Denise Fulton, Vice President of Research & Content Strategy, and is assisted by other staff members from across all RAPS departments.
Regulatory Focus is overseen by an Editorial Advisory Committee, volunteer regulatory professionals who are experts in their respective fields and guide the news and feature teams in providing RAPS members and subscribers the news and intelligence they need each day.
Contact the Regulatory Focus news team at news@raps.org and the features team at featureseditor@raps.org.