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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.

CDRH Learn

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

FDA Workshops & Conferences (Medical Devices)

CDER Learn

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

CBER News and Events

OTAT Learn

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

FDA CDER Small Business & Industry Assistance (SBIA)

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

CDER Regulatory Science Newsletter

What’s New in Regulatory Science is a quarterly newsletter from the Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER). It features new developments, opportunities, and initiatives in drug development regulatory science, with the goal of advancing medical product development. This newsletter is brought to you by the Office of Translational Sciences (OTS) in collaboration with the Office of Communications within the Center for Drug Evaluation and Research (CDER).

Additional Topics of Interest

Japanese Regulatory Approval Process Chart
Before selling medical and in vitro diagnostic (IVD) devices in Japan, manufacturers must first register their products. The Ministry of Health, Labour and Welfare (MHLW) oversees registration, the Pharmaceuticals and Medical Devices Agency (PMDA), and third-party Registered Certification Bodies (RCBs).  To better understand the registration process, view Emergo by UL’s informative process chart, available for download in Regulatory Affairs Management Suite (RAMS):

Whitehat Communications Point of Care Group Webinars

Whitehat produces webinars for the hospital laboratory and point of care community across the US. These educational sessions present a wide range of educational and practical topics chosen by the groups themselves. The educational segments are delivered by respected experts, and offer one P.A.C.E.® Continuing Education contact hour to attendees for 6 months after the live event.
For more information and to register: 

Live ISO 14971 Certification Training presented by Achieve

Take your career to the next level by earning a certificate of competence in ISO 14971. There is a high demand for competent professionals who can help establish and maintain a compliant risk management system for medical devices. After completing this course, you will have the knowledge and tools available to build a risk management file for your medical device. This is highly transferrable skill across the medical device industry.
Watch a free lesson and register 

BSI Webinar series: MDR Clinical Evaluation Masterclass - Freely Available

The timelines for ensuring your product maintains EU market access under the new, more stringent Medical Device Regulations (MDR) are challenging. These five insightful webinars will help you focus on various aspects of the MDR, from looking at post-market clinical follow-up, to helping you with your medical device software and when a clinical evaluation is required.
Watch on demand webinars.

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

WIRB - Copernicus Group® (WCG) Free Webinars
Visit WCG's Webinar Series page for 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

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.