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.
RAPS continues to monitor the on-going Coronavirus pandemic and has compiled the following resources to help you stay informed on this rapidly evolving situation. Please check back regularly for updates and to learn more about special programs RAPS has available to support you and your professional development during this difficult time.
Please visit our public safety page for the updates to RAPS policies and procedures in response to COVID-19.
Stakeholders are looking to repurpose approved drugs that have worked against similar coronaviruses in the past or are hypothesized to attack or immobilize SARS-CoV-2 based on the mechanism of action.
This tracker will be updated weekly with the latest in developments for these treatment candidates.
Experts estimate it could take between 12-18 months to develop a vaccine ready for market, which assumes the process from conception to market availability goes smoothly.
This tracker lists the major vaccine candidates in development for prevention of COVID-19
Check out daily round-ups on the latest COVID-19 guidance from the FDA, EU, EMA and more.
Are you a life science company working on COVID-19?
Thera-Business is offering a free 1 hour consultation regarding literature search strategies and 5 key steps for performing a literature review for COVID-19 projects.
LEARN MORE >>
Pacific Bridge Medical is now doing quality audits in China for PPE products to be sold to the U.S. due to the pandemic.
Utilize their on-the-ground, experienced, quality staff in China to do this work and save 10%.
Tap into COVID-19 support and get answers to your regulatory compliance, quality management and on-going pharmacovigilance questions from experts across the globe who understand the current challenges and deliver solutions remotely.
Posted 25 September 2020 | By Michael Mezher
More than 30 leading experts and academics in regulatory science and medicine have signed an open letter calling on US Food and Drug Administration (FDA) Commissioner Stephen Hahn to protect t...
Posted 25 September 2020 | By Jeff Craven
This update includes new entries for PB1046 and galidesivir and updates on dexamethasone, Actemra and convalescent plasma.
Posted 24 September 2020 | By Jeff Craven
This update includes trial protocols from Johnson & Johnson and AstraZeneca as well as new information on vaccine candidates from Johnson & Johnson, CanSino Biologics, Sinovac, and on the BCG ...
Posted 23 September 2020 | By Michael Mezher
Testifying before the Senate Health, Education, Labor and Pensions Committee on Wednesday, US Food and Drug Administration (FDA) Commissioner Stephen Hahn said that politics will not play a pa...
Posted 23 September 2020 | By Mary Ellen Schneider
The United States continues to struggle with shortages of personal protective equipment (PPE) and testing supplies due to high global demand and the fact that most supplies are made outside of...
Posted 22 September 2020 | By Denise Fulton
“The dueling statements of vaccine makers and the president have set the stage for critical decisions in the next 2 months…. The federal response will help determine not just the fate of the f...
Posted 22 September 2020 | By Kari Oakes
Investigators of new drugs must continue to send safety reports of serious and unexpected adverse events to their institutional review boards during the public health emergency of the novel co...
Posted 21 September 2020 | By Kari Oakes
Countries representing nearly two thirds of the world’s population have now signed on to The World Health Organization’s COVID-19 vaccine development and manufacturing accelerator. In all, 64 ...
Posted 21 September 2020 | By Michael Mezher
The European Medicines Agency’s (EMA) on Friday recommended seven medicines for marketing authorization and began a public consultation on the International Council for Harmonisation’s (ICH) Q...
Posted 16 September 2020 | By Kari Oakes
As the coronavirus pandemic swept through major US cities in the spring of 2020, the US Food and Drug Administration took unprecedented steps to address shortages and bring tests and potential...
Reach out to collaborate with your peers and colleagues in the RAPS Regulatory Exchange community, and stay connected anytime, anyplace with our new RegEx mobile app.
Join active coronavirus threads on the RAPS membership community.