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      RAPS COVID-19 Resource Center


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.
 

Highlighted Resources

COVID-19 Therapeutics Tracker

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.

COVID-19 Vaccine Tracker

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

A New Way to Stay Connected

In response to these challenging times, our RAPS Chapters have converted their regular in-person events to virtual webcasts that are free with your membership.

Explore different regulatory communities and topics while benefiting from the collective knowledge of the full RAPS chapter network.

MedBoard COVID-19 Tracker

MedBoard has developed a COVID-19 tracking webpage that collects all of the regulations, guidance and notices related to medical devices and in vitro diagnostic products (IVDs) and the keywords: 'covid-19', 'sars-cov-2' and 'coronavirus'.

This tracker is updated daily.

EMBL-EBI COVID-19 Data Portal

EMBL-EBI has launched the COVID-19 Data Portal to bring together relevant datasets for sharing and analysis in an effort to accelerate coronavirus research. It enables researchers to upload, access and analyze COVID-19 related reference data and specialist datasets as part of the wider European COVID-19 Data Platform.

COVID-19 Authority Updates

Check out daily round-ups on the latest COVID-19 guidance from the FDA, EU, EMA and more.

 

Special Offers

Ethics — Essential Tools for Regulatory Professionals

Learn the importance of doing the right thing when product quality is at risk.

MEMBERS: $465.00
NONMEMBERS: $640.00

FREE until 31 December 2020

Business & Leadership Collection

RAPS is opening up this collection of on-demand webcasts to support your professional development during this difficult time.

Nonmembers will need to create a login to view the webcasts.

FREE until 31 December 2020

1 Hour Free Consultation

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 >>

Save 10% on Quality Audits

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%.


LEARN MORE >>

#AskTheExpert

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.

Regulatory Focus™ Articles

 

COVID-19 therapeutics tracker

Posted 23 November 2020 | By Jeff Craven 

Updated 23 November to include the US FDA emergency use authorization of casirivimab and imdevimab (REGN-COV2).

COVID-19 vaccine tracker

Posted 23 November 2020 | By Jeff Craven 

Updated 23 November  with new information on the vaccine candidate from AstraZeneca/University of Oxford. 

Updated: Pfizer files EUA for COVID vaccine; FDA sets adcomm for 10 December

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...

WHO backs off on remdesivir as FDA issues another EUA

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.  

EMA sets 50% efficacy goal – with flexibility – for COVID vaccines

Posted 19 November 2020 | By Kari Oakes 

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...

Recon: Pharma supply chain vulnerable during COVID; OIG takes aim at pharma speaker program

Posted 19 November 2020 | By Kari Oakes 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.  

COVID rapid diagnostic options expand with at-home LAMP test

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...

Hahn addresses EUAs, transition to approvals in conversation with RAPS members

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...

FDA commits to data transparency in COVID EUAs

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 ...

NIH director: Efficacy for co-developed Moderna vaccine nears 95%

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...

COVID-19 Public Health Resources

Access links to specific COVID-19 government resources from around the globe:

 

Engage with RegEx Discussions

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.