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.
Convergence 2020 has come and gone, but you can still access recorded sessions, which are available to attendees until 31 December 2020.
Replay the moments of Euro Convergence 2020. Recorded sessions are available to attendees until 31 January 2020.
RAPS' “how to” guide to developing a comprehensive global regulatory strategy for all types of medical devices. Updated September 2020.
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.
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 23 November 2020 | By Jeff Craven
Updated 23 November to include the US FDA emergency use authorization of casirivimab and imdevimab (REGN-COV2).
Updated 23 November with new information on the vaccine candidate from AstraZeneca/University of Oxford.
Posted 20 November 2020 | By Kari Oakes
With favorable results from a completed Phase 3 clinical trial of their jointly developed vaccine against COVID-19, Pfizer and BioNTech have submitted an emergency use authorization (EUA) appl...
Posted 19 November 2020 | By Kari Oakes
The World Health Organization is recommending against the use of the antiviral remdesivir (Veklury, Gilead) for the treatment of COVID-19.
The European Medicines Agency (EMA) has released its planned framework for issuing marketing authorizations for vaccines against COVID-19, as the agency continues its rolling reviews of candid...
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Posted 18 November 2020 | By Kari Oakes
US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to the first COVID-19 diagnostic test that can be used to provide rapid results at-home. The newly authorize...
Posted 17 November 2020 | By Michael Mezher
Real-world data has proven useful in demonstrating the performance of COVID-19 diagnostics, but has not always lined up with the data submitted to support the emergency use authorizations (EUA...
Posted 17 November 2020 | By Kari Oakes
As the time draws near for the leaders in the global race for a vaccine against COVID-19 to submit emergency use authorizations (EUAs) to the US Food and Drug Administration (FDA), the agency ...
Posted 16 November 2020 | By Kari Oakes
The director of the National Institutes of Health (NIH) reported favorable efficacy results after an interim analysis of data from the COVE Phase 3 efficacy trial of mRNA-1273, the messenger R...
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.