Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
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.
Posted 22 October 2012
A new discussion paper generated by three of the EU's top scientific committee has called for a paradigm shift in the way regulators assess risks to human health from a hazard-driven process to one driven by exposure.
The paper, Addressing the New Challenges for Risk Assessment, was issued by three of the European Commission's Scientific Committees: the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), the Scientific Committee on Consumer Safety (SCCS) and the Scientific Committee on Health and Environmental Risks (SCHER).
The paper notes that the new approach to risk assessment would require major improvements in the assessment of exposure to individual chemicals and groups of chemicals, and major changes in the identification and characterization of hazards to humans.
In investigations using laboratory animals, the paper notes that increasing importance should be directed to characterizing the mode of action with less emphasis to endpoints based on histopathological criteria, body and organ weight, and blood chemistry.
The European Commission has launched a public consultation on the paper and the deadline for comments is November 30, 2012.
Read more:
Read all Breaking News from RegLink
Tags: Hazards, SCCS, SCHER, ECm SCENIHR, Risk Assessment, Report, Latest News, risk, exposure
Regulatory Focus newsletters
All the biggest regulatory news and happenings.