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.
RAPS Convergence is going virtual. Join the brightest minds in regulatory online to gain the latest knowledge in the field in an all-virtual experience with workshops, one-on-one expert sessions, and networking communities.
This year, our European regulatory community will converge online with a fully virtual program that will allow attendees to experience Euro Convergence live online from the safety and comfort of their homes.
RAPS' “how to” guide to developing a comprehensive global regulatory strategy for all types of medical devices. Updated September 2020.
The last exam window of 2020 is currently open. Register by 8 October to take the RAC exam this autumn.
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.
RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.
Posted 25 July 2013 | By Louise Zornoza,
The UK's National Institute for Health and Care Excellence (NICE) issued final guidance on 24 July 2013 recommending reimbursement for Bayer's Eylea (aflibercept solution for injection) as an option for treating wet age-related macular degeneration (AMD) only if it is used in accordance with the recommendations for ranibizumab.
Clinical commissioning groups in England, the National Health Service (NHS) England and local authorities must comply with the NICE recommendations within three months of the date of publication.
There are an estimated 26,000 new cases of wet AMD in the UK each year. Risk factors include increasing age, cigarette smoking (smokers having a 3.6 times greater risk of developing age-related macular degeneration compared with people who have never smoked), and exposure to high levels of UV light. It is also more common in women than men.
NICE Guidance on Eylea
Read all Breaking News from RegLink
Tags: Final Guidance, Bayer, UK, guidance, EU
Regulatory Focus newsletters
All the biggest regulatory news and happenings.