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

Update: Implications to Life Science Companies Relating to COVID-19

Our experts explain what is required during the COVID-19 crisis.

MEMBERS: FREE
NONMEMBER: $20.00 FREE until 15 July 2020

Implications to Life Science Companies Relating to COVID-19

Learn how COVID-19 changes will impact market entry to both the US and China.

MEMBERS: FREE
NONMEMBER: $20.00 FREE until 15 July 2020

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 15 July 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 15 July 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 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...

FDA updates COVID-19 therapeutics website

Posted 14 July 2020 | By Kari Oakes 

The US Food and Drug Administration (FDA) has to date reviewed over 230 trials of potential therapeutics to treat the novel coronavirus (COVID-19), according to a blog post by FDA commissioner...

FDA looks to resume domestic inspections this month

Posted 10 July 2020 | By Michael Mezher 

Months after halting most inspections amid the coronavirus disease (COVID-19) pandemic, the US Food and Drug Administration (FDA) on Friday said it plans to resume on-site domestic inspections...

COVID-19 therapeutics tracker

Posted 10 July 2020 | By Jeff Craven 

This update includes new information on Veklury, hydroxychloroquine and Kaletra, REGN-COV2, ABX464 and Kevzara.

Marks on COVID-19 vaccine efficacy, EUAs and challenge trials

Posted 09 July 2020 | By Michael Mezher 

A week after the US Food and Drug Administration (FDA) issued guidance on vaccines to prevent coronavirus disease (COVID-19), Peter Marks, director of the Center for Biologics Evaluation and R...

ICMRA outlines shape of Phase 3 COVID-19 vaccine trials

Posted 09 July 2020 | By Kari Oakes 

A new report provides a roadmap for Phase 3 clinical trials for developers of candidate vaccines for the novel coronavirus SARS-CoV-2, the virus that causes COVID-19. The report indicates whic...

COVID-19 vaccine tracker

Posted 09 July 2020 | By Jeff Craven 

This update includes new information on vaccine candidates from Voltron Therapeutics, Pfizer/BioNTech, Novavax, Medicago, Clover Biopharmaceuticals and Imperial College London.

NIH kicks off COVID-19 vaccine, monoclonal antibody research network

Posted 08 July 2020 | By Kari Oakes 

The National Institutes of Health (NIH) today announced the kickoff of a national clinical trials network to test vaccines and other treatments that could prevent infection with SARS-CoV2, the...

FDA clarifies informed consent provisions in COVID-19 clinical guidance

Posted 07 July 2020 | By Michael Mezher 

The US Food and Drug Administration (FDA) last week updated its guidance on conducting clinical trials amid the coronavirus disease (COVID-19) pandemic to clarify how sponsors can obtain infor...

EU agencies clarify pharmacovigilance expectations amid COVID-19

Posted 01 July 2020 | By Michael Mezher 

In an update to their joint questions and answers document on regulatory expectations for medicinal products amid the coronavirus disease (COVID-19) pandemic, the European Medicines Agency (EM...

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.