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

 

Oncology research mid-pandemic: Challenges may bring durable innovation

Posted 19 October 2020 | By Kari Oakes 

Data integrity issues and “pandemic-induced protocol deviations” are a concern for oncology trial sponsors and FDA alike, and the agency has been attempting to be as flexible as is possible wh...

Recon: New healthcare investing record; Sanofi slim-down, sell-off?

Posted 19 October 2020 | By Kari Oakes 

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

FDA reissues Chinese respirator EUA, but freezes new additions

Posted 16 October 2020 | By Kari Oakes 

The emergency use authorization (EUA) for certain types of filtering face-piece respirators has been reissued by the US Food and Drug Administration (FDA) as the public health emergency of the...

Top CDER officials discuss budget priorities, staffing and COVID

Posted 16 October 2020 | By Michael Mezher 

With negotiations underway for the next iterations of the US Food and Drug Administration’s (FDA) new and generic drug user fee programs, top officials from the Center for Drug Evaluation and ...

EC lays out strategy for effective COVID vaccine rollout

Posted 16 October 2020 | By Kari Oakes 

The European Commission (EC) has set out key steps for effective strategies member states should use to deploy vaccines against COVID-19 when they become available.  

COVID-19 therapeutics tracker

Posted 16 October 2020 | By Jeff Craven 

Updated 16 October to include a new entry for CT-P59 and updates on LY-Cov555, STI-5656 (abivertinib), RLF-100, lenzilumab and niclosamide.   

FDA officials, experts discuss impact of COVID-19 on cell and gene therapies

Posted 15 October 2020 | By Michael Mezher 

While the US Food and Drug Administration (FDA) is still receiving investigational new drug applications (INDs) for cell and gene therapies, officials are concerned about the impact of the COV...

COVID-19 vaccine tracker

Posted 15 October 2020 | By Jeff Craven 

Updated 15 October to include new information on vaccine candidates from the Russian State Research Center of Virology and Biotechnology, Johnson & Johnson, the Gamaleya Research Institute, ...

During pandemic, FDA permits some respiratory swab, media swaps

Posted 14 October 2020 | By Kari Oakes 

Amid the coronavirus pandemic, the US Food and Drug Administration (FDA) has made new guidance immediately effective that addresses its enforcement policy for modifications to previously clear...

TGA gives Pfizer COVID vaccine provisional determination

Posted 14 October 2020 | By Kari Oakes 

Another vaccine against SARS-CoV-2, the virus that causes the novel coronavirus, has received provisional determination from Australia’s Therapeutic Goods Administration (TGA). Pfizer, doing b...

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.