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 26 February 2015 | By Michael Mezher
The Therapeutic Goods Administration (TGA) this week issued a safety advisory over two smoking devices that bear strong resemblance to metered dose inhalers used to treat asthma and other medical conditions.
TGA says the devices, known as the Puffit and Puffix-X, are designed to “burn vegetable material such as herbs or tobacco,” which is then inhaled as smoke.
The agency fears that the products’ similarity to metered dose inhalers could create confusion for patients who require an inhaler for medical purposes. Though the devices are labelled “this is not a medical device,” patients with respiratory conditions such as asthma or chronic obstructive pulmonary disease (COPD) could attempt to use the Puffit device by mistake.
TGA says in case of confusion patients should verify the contents of their inhaler by looking at the label on the canister insert.
The TGA advisory contains photographs comparing the appearance of the Puffit device to an approved metered dose inhaler.
The company marketing the Puffit devices, Discreet Vape, does not mention the resemblance its products bear to metered dose inhalers on its website.
TGA Advisory
Tags: Safety Advisory, Metered Dose Inhaler
Regulatory Focus newsletters
All the biggest regulatory news and happenings.