RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 

      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

 

Global regulators agree on endpoints for COVID-19 therapeutics

Posted 31 July 2020 | By Michael Mezher 

Regulators participating in the International Coalition of Medicines Regulatory Authorities (ICMRA) last week reached a consensus on endpoints that would be acceptable as primary endpoints in ...

COVID-19 therapeutics tracker

Posted 31 July 2020 | By Jeff Craven 

This update includes new information on dexamethasone, RLF-100, Actemra, lenzilumab, convalescent plasma, Pepcid, TXA127, LAM-002A and DNL758.

COVID-19 vaccine tracker

Posted 30 July 2020 | By Jeff Craven 

This update includes new information on vaccine candidates from Moderna, Pfizer/BioNTech, Heat Biologics, Gamaleya Research Institute and Covaxin. 

FDA issues at-home and OTC COVID-19 testing template

Posted 29 July 2020 | By Kari Oakes 

 Developers of COVID-19 diagnostic tests designed for at-home and over-the-counter use have a new template they can use to submit emergency use authorization (EUA) requests to the US Food and ...

Hahn says COVID-19 vaccines will be reviewed in ‘real time’

Posted 28 July 2020 | By Michael Mezher 

At an event marking the launch of Moderna’s Phase 3 clinical trial for its mRNA coronavirus vaccine in Miami on Monday, US Food and Drug Administration (FDA) Commissioner Stephen Hahn repeated...

Drugmakers to Congress: Trust an FDA-approved COVID-19 vaccine

Posted 21 July 2020 | By Michael Mezher 

The public should have confidence in any COVID-19 vaccine approved by the US Food and Drug Administration (FDA), according to the testimony presented by five top pharmaceutical executives at a...

FDA issues enforcement policy for coronavirus transport media

Posted 20 July 2020 | By Michael Mezher 

The US Food and Drug Administration (FDA) on Monday issued an immediately effective guidance to boost the availability of transport media intended to be used to transport clinical specimens fo...

FDA approves pooled sampling for COVID-19 test

Posted 20 July 2020 | By Denise Fulton 

Four samples may be processed together in a batch, reducing the number of tests run and using fewer testing supplies.

Experts urge transparency, advisory committee review for COVID-19 vaccines

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...

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.