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

 

Experts call on Hahn to shield FDA from political influence

Posted 25 September 2020 | By Michael Mezher 

More than 30 leading experts and academics in regulatory science and medicine have signed an open letter calling on US Food and Drug Administration (FDA) Commissioner Stephen Hahn to protect t...

COVID-19 therapeutics tracker

Posted 25 September 2020 | By Jeff Craven 

This update includes new entries for PB1046 and galidesivir and updates on dexamethasone, Actemra and convalescent plasma.

COVID-19 vaccine tracker

Posted 24 September 2020 | By Jeff Craven 

This update includes trial protocols from Johnson & Johnson and AstraZeneca as well as new information on vaccine candidates from Johnson & Johnson, CanSino Biologics, Sinovac, and on the BCG ...

Hahn pledges no politics in COVID vaccine decisions

Posted 23 September 2020 | By Michael Mezher 

Testifying before the Senate Health, Education, Labor and Pensions Committee on Wednesday, US Food and Drug Administration (FDA) Commissioner Stephen Hahn said that politics will not play a pa...

GAO highlights continued PPE shortages in COVID-19 report

Posted 23 September 2020 | By Mary Ellen Schneider 

The United States continues to struggle with shortages of personal protective equipment (PPE) and testing supplies due to high global demand and the fact that most supplies are made outside of...

COVID-19 vaccine: Experts warn of waning public confidence

Posted 22 September 2020 | By Denise Fulton 

“The dueling statements of vaccine makers and the president have set the stage for critical decisions in the next 2 months…. The federal response will help determine not just the fate of the f...

Adverse event reporting clarified in FDA’s COVID-19 clinical trial guidance

Posted 22 September 2020 | By Kari Oakes 

Investigators of new drugs must continue to send safety reports of serious and unexpected adverse events to their institutional review boards during the public health emergency of the novel co...

WHO: Two-thirds of global population now participating in COVAX initiative

Posted 21 September 2020 | By Kari Oakes 

Countries representing nearly two thirds of the world’s population have now signed on to The World Health Organization’s COVID-19 vaccine development and manufacturing accelerator. In all, 64 ...

EMA backs dexamethasone for COVID-19, seven new medicines and consults on ICH Q3D guideline

Posted 21 September 2020 | By Michael Mezher 

The European Medicines Agency’s (EMA) on Friday recommended seven medicines for marketing authorization and began a public consultation on the International Council for Harmonisation’s (ICH) Q...

At Convergence, CDRH details its pandemic response

Posted 16 September 2020 | By Kari Oakes 

As the coronavirus pandemic swept through major US cities in the spring of 2020, the US Food and Drug Administration took unprecedented steps to address shortages and bring tests and potential...

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.