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Organization of Regulatory and Clinical Associates
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Organization of Regulatory and Clinical Associates
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Knowledge Center

Useful FDA educational resources

The FDA Continuing Education (CE) program serves an interprofessional team including physicians, pharmacists, nurses, attorneys, clinical and non-clinical scientists across the FDA. In addition, the FDA CE program provides continuing education credit to outside healthcare professionals through workshops, courses, seminars and online activities offered to the public.
https://www.fda.gov/training-and-continuing-education/fda-continuing-education-programs



CDRH Learn

FDA’s Center for Devices and Radiological Health (CDRH) web page for multimedia industry education.

https://www.fda.gov/training-and-continuing-education/cdrh-learn


FDA Workshops & Conferences (Medical Devices)

https://www.fda.gov/medical-devices/news-events-medical-devices/workshops-conferences-medical-device



CDER Learn

The web page for educational tutorials offered by the Center for Drug Evaluation and Research.

https://www.fda.gov/training-and-continuing-education/cderlearn-training-and-education


CBER News and Events 

https://www.fda.gov/vaccines-blood-biologics/news-events-biologics



OTAT Learn

The Center for Biologics, Evaluation and Research's (CBER) Office of Cellular, Tissue and Gene Therapies (OCTGT) web page for industry education.

https://www.fda.gov/vaccines-blood-biologics/news-events-biologics/otat-learn



FDA CDER Small Business & Industry Assistance (SBIA)

https://www.fda.gov/drugs/development-approval-process-drugs/cder-small-business-industry-assistance


FDA CDER Small Business and Industry Assistance (SBIA) Learn
Searchable Database Now Available for Training Resources on FDA’s Updated CDER SBIA Learn Webpage

CDER Small Business and Industry Assistance (SBIA) Learn


Additional Topics of Interest


The 2021 FDA Science Forum - Science as the Foundation for Protecting and Promoting Public Health
Keynote Speaker: NIAID Director Dr. Anthony Fauci
The 2021 FDA Science Forum will be held virtually on Wednesday and Thursday, May 26 and 27, 2021. The Forum offers an exciting opportunity for the public to view the unique scientific research and collaborative efforts of FDA’s 11,000 scientists. Click here for more information.



Clinical & Medical Affairs - Clinical Trials Europe 2020 Post-Event Report - Freely Available

Visit informaconnect.com


All New England Journal of Medicine Content Related to the Covid-19 Pandemic - Freely Available

Visit New England Journal of Medicine Free Covid-19 Content


The COVID-19 Lit Rep
The COVID-19 Lit Rep is currently prepared by the UW Alliance for Pandemic Preparedness and the START Center in collaboration with and on behalf of the Washington State Department of Health. The Lit Rep was originally developed and disseminated by the WA DOH COVID-19 Incident Management Team to support evidence-based decision making throughout the region.
Click here to subscribe.



WIRB - Copernicus Group® (WCG) Free Webinars
Visit WCG's clinical page under webinars sections on the right for upcoming webinar registrations and past webinars available on demand.


edX - The FDA and Prescription Drugs: Current Controversies in Context
Understand how the FDA regulates pharmaceuticals and explore debates on prescription drug costs, marketing and testing.


New Device Advice e-Learning Tool
The Medical Devices Bureau has announced the launch of a new Device Advice: e-Learning tool “Understanding How Medical Devices are Regulated in Canada – Premarket Regulations”. This learning module is intended to help stakeholders better understand what the premarket regulatory requirements are for the importation or sale of medical devices in Canada. 


LifeScience Washington Programs

Click here for more info on LifeScience Washington programs and events.


Tech Tip Videos
Cell Signaling Technology videos


The Robert J. Margolis, M.D. Center for Health Policy 
Calendar of Events


New Medical Device Regulatory Intelligence Service from Emergo

The Regulatory Affairs Management Suite (RAMS) digital platform for global market access enables manufacturers to manage their device registrations and certifications across multiple countries and gain valuable market insights from a single, fully automated system. The software includes new tools and capabilities to support streamlined RA/QA operations including: Registration Tracker and Regulatory Updates; Regulatory Overview Reports for 22 Markets; All of Emergo’s Regulatory Process Charts; Copies of global regulations already in Emergo’s website, plus expanded list of regulations and added markets; FDA 510(k) review time calculator and classification support, which extracts real-time information through connection with the FDA’s website; Regulatory FAQs to answer common and not so common questions and issues.


Elsmar Cove
A Free Business Standards Compliance and Business Systems Information Resource to Quality Assurance, Engineering and Management Professionals.
https://elsmar.com/