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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.
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.
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.
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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 15 January 2021 | By Michael Mezher
Documents related to COVID-19 vaccines that were unlawfully accessed in a cyberattack against the European Medicines Agency (EMA) and subsequently leaked online were intentionally manipulated,...
New guidance from the US Food and Drug Administration (FDA) issued on Friday provides recommendations for resuming or initiating bioequivalence (BE) studies for generic drugs during the COVID-...
Posted 15 January 2021 | By Mary Ellen Schneider
The report, prepared by an external third party with input from FDA staff and stakeholders, provides recommendations for how to continue or expand the current regulatory flexibility beyond the...
Posted 15 January 2021 | By Jeff Craven
Updated 15 January to include new information on convalescent plasma, Actemra/Kevzara, RLF-100, Ultomiris, Veklury, CT-P59 and Vir-7831/Vir-7832
Posted 14 January 2021 | By Kari Oakes
Amid the coronavirus pandemic, the US Food and Drug Administration has issued guidance on potency assays for manufacturers of monoclonal antibodies and other therapeutic proteins to treat COVI...
Posted 14 January 2021 | By Jeff Craven
Updated 14 January to include new information on authorized or approved vaccines from Pfizer/BioNTech, Moderna, Sinovac, AstraZeneca and Gamaleya Institute as well as vaccine candidates from...
Posted 12 January 2021 | By Kari Oakes
The European Medicines Agency (EMA) could issue an opinion on the COVID-19 vaccine co-developed by AstraZeneca and the University of Oxford as early as 29 January, according to a press release...
An early December cyberattack on the European Medicines Agency (EMA) only involved one information technology application, reported the agency in its third update on the data breach.
Posted 11 January 2021 | By Michael Mezher
With the transition to a new administration less than two weeks away, US Food and Drug Administration (FDA) Commissioner Stephen Hahn on Friday told reporters at an Alliance for Health Policy ...
Posted 08 January 2021 | By Kari Oakes
As the first week of the new year winds down, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved a third vaccine against COVID-19. On Friday, MHRA announced its 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.