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

 

Cyberattack: EMA says leaked documents ‘manipulated’

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,...

FDA issues guidance on resuming or initiating BE studies amid pandemic

Posted 15 January 2021 | By Michael Mezher 

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-...

PREPP initiative: FDA’s COVID-19 response and the path forward

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...

COVID-19 therapeutics tracker

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

FDA issues potency testing guidance for COVID antibody treatments

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...

COVID-19 vaccine tracker

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...

EMA considers AstraZeneca vax; Swissmedic okays Moderna's

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...

Updated: Documents leaked to the internet in wake of EMA cyberattack

Posted 12 January 2021 | By Kari Oakes 

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.  

Hahn offers advice to incoming Biden administration

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 ...

MHRA okays third COVID-19 vaccine

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...

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.