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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.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
With so many global regulation changes, staying informed is a challenge. Join other regulatory professionals as you navigate the gray together.
Learn how recent changes to the regulation of healthcare products in the EU will impact you as a regulatory professional.
In light of the COVID-19 pandemic, the RAC Board has elected to offer online testing with live online proctoring this summer.
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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 14 July 2020 | By Michael Mezher
At a virtual briefing on Tuesday, several experts told members of the House Committee on Oversight and Reform Subcommittee on Economic and Consumer Policy that a transparent process and adviso...
Posted 14 July 2020 | By Kari Oakes
The US Food and Drug Administration (FDA) has to date reviewed over 230 trials of potential therapeutics to treat the novel coronavirus (COVID-19), according to a blog post by FDA commissioner...
Posted 10 July 2020 | By Michael Mezher
Months after halting most inspections amid the coronavirus disease (COVID-19) pandemic, the US Food and Drug Administration (FDA) on Friday said it plans to resume on-site domestic inspections...
Posted 10 July 2020 | By Jeff Craven
This update includes new information on Veklury, hydroxychloroquine and Kaletra, REGN-COV2, ABX464 and Kevzara.
Posted 09 July 2020 | By Michael Mezher
A week after the US Food and Drug Administration (FDA) issued guidance on vaccines to prevent coronavirus disease (COVID-19), Peter Marks, director of the Center for Biologics Evaluation and R...
Posted 09 July 2020 | By Kari Oakes
A new report provides a roadmap for Phase 3 clinical trials for developers of candidate vaccines for the novel coronavirus SARS-CoV-2, the virus that causes COVID-19. The report indicates whic...
Posted 09 July 2020 | By Jeff Craven
This update includes new information on vaccine candidates from Voltron Therapeutics, Pfizer/BioNTech, Novavax, Medicago, Clover Biopharmaceuticals and Imperial College London.
Posted 08 July 2020 | By Kari Oakes
The National Institutes of Health (NIH) today announced the kickoff of a national clinical trials network to test vaccines and other treatments that could prevent infection with SARS-CoV2, the...
Posted 07 July 2020 | By Michael Mezher
The US Food and Drug Administration (FDA) last week updated its guidance on conducting clinical trials amid the coronavirus disease (COVID-19) pandemic to clarify how sponsors can obtain infor...
Posted 01 July 2020 | By Michael Mezher
In an update to their joint questions and answers document on regulatory expectations for medicinal products amid the coronavirus disease (COVID-19) pandemic, the European Medicines Agency (EM...
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.