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 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.
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.
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.
Registration is now open for RAPS Euro Convergence 2021! Attend to join peers from EU and around the world to gain insights and exchange ideas on the regions most pressing issues.
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.
Posted 14 November 2013 | By Alexander Gaffney, RAC,
The Asian Harmonization Working Party (AHWP) has announced the release of two proposed regulatory documents for public comment, one on adverse event reporting for medical devices and the other on the quality management system used by device manufacturers.
AHWP is an international organization focused on harmonizing medical device regulation and policies across its 23 member countries. While those countries are primarily in Asia-China, India, Saudi Arabia, Singapore, etc-the group also includes some outside the Asia region like South Africa and Chile.
The group's 13 November 2013 announcement, a call for comments, related to two documents: Adverse Event Reporting Guidance for the Medical Device Manufacturer or its Authorized Representative, and Quality management system - Medical devices - Nonconformity Grading System for Regulatory Purposes and Information Exchange.
The former is intended to establish the conditions under which an adverse event should be reported to the relevant regulatory authority and when. According to the guidance, "typical events" include device malfunctions, deterioration in characteristics or performance, inadequate design, inadequate manufacture, significant public health concerns, and inaccurate labeling resulting in serious injury or death.
The devices should be associated with the adverse event, though AHWP concedes this "judgment may be difficult when there are multiple devices and drugs involved," but says that a presumption of association should be made in "complex situations."
Adverse events should also be reported to relevant authorities in cases where harm was narrowly averted, indicating that a less-favorable outcome might happen in the future.
The document also contains examples of when adverse events should not be reported, such as when an event is caused by the underlying disease the device is trying to treat or if a defect occurs during pre-insertion testing as specified under the device's instructional labeling.
The latter document pertains to the quality management system used by device companies, and in particular the grading system for nonconformities.
The document should already be familiar to most within the device regulatory community, as it was produced by the Global Harmonization Task Force (GHTF), a now-defunct global harmonization body for device regulation that has been largely replaced by the International Medical Device Regulators Forum (IMDRF).
The guidance had originally been developed in partnership between GHTF and AHWP, and the latter has apparently endeavored to keep it updated since its 2012 final release.
The document introduces a standardized format for grading nonconformities, involving a grading matrix (first or repeat occurrence; indirect or direct impact on quality) and a final assessment scale of one (least-bad) to five (worst). Extensive examples of what constitutes each grade are given within the guidance.
Comments on both documents are due by 26 November 2013.
AHWP: Nonconformity Guidance
AHWP: Adverse Event Guidance
Tags: AHWP
Regulatory Focus newsletters
All the biggest regulatory news and happenings.