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Organization of Regulatory and Clinical Associates
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Organization of Regulatory and Clinical Associates
P.O. Box 3490
Redmond, WA 98073

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Free Webinar by Emergo: MDR and Human Factors – get ready for transition

January 23, 2020 | 9am CST

This webinar will be available for viewing at a later time if you register.

The three-year transition period from MDD to MDR comes to an end on May 26th 2020. Among the many regulatory changes, the role of human factors is greatly enhanced. Manufacturers are expected to show evidence of complying with explicit, clearly defined requirements for use-related safety. And notified bodies are expected to examine your usability work closely.

The clock is ticking, but there is still time to get your human factors and usability engineering processes in shape. In this webinar, Richard Featherstone (Research Director) and Yvonne Limpens (Managing Human Factors specialist) from Emergo by UL’s human factors research and design team will review the role of usability engineering in MDR, highlighting the key requirements.

They will describe the implications for your usability work, and provide a ‘road-map to MDR compliance’ from a human factors perspective, finishing up with some ‘top tips’ for the months ahead as we approach the end of MDD to MDR transition.

Click here for more information or to register for this webinar.


PDA Pacific NW Dinner: Drug Discoveries thru AI
Speaker: Tina M. Larson, COO of Recursion Pharmaceuticals
Date & Time: Wednesday, February 26 from 6 PM-8:45 PM
Location: 400 Dexter Ave N, 2nd Floor Classrooms, Seattle, WA 98109

AI, machine learning, and other "deep tech" has changed the face of several industries and our daily lives. The last few years have seen an explosion of companies applying deep tech to drug discovery and development.

In this event, Larson will
• Discuss what it is like to work at a tech meets biotech startup
• Give an overview of Recursion, a leader in the digital drug discovery space.
• Provide the broader field of artificial intelligence for drug discovery

Prior to joining Recursion, Larson was Achaogen's Senior VP of Technical Operations. Before that, Larson spent 20 years at Genentech and Roche, holding leadership positions in Technical Development, Manufacturing, and Engineering. Larson has a Bachelor of Science in Chemical Engineering from Colorado State University and currently serves on the Dean's Advisory Board for the Walter Scott, Jr. College of Engineering.

Click here for more information or to register.



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.


Key capabilities include:

  • 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

 

Note: To Activate all features, make sure to enable them after signup by visiting the RAMS Marketplace. For questions, contact bdwest@ul.com


JOB SHADOWING PROGRAM

Do you think you would like to share a day with a regulatory student, showing them how you do your job? 

Do you want to show a student ways to think through challenges, adapt to the new ISO rules, understand different country regulatory changes, or understand new biologics as examples. 

We are actively reaching out to match the newest members of our profession at the University of Washington’s BRAMS program with host ORCA members. Spend a day together.

This is an opportunity available to current members only.

Please contact Elizabeth Cross Nichol for more information or click on the buttons below to fill out an information or application form.


Host Information Form

Observer Application Form


ORCA NEEDS YOUR HELP!

Volunteers are vital to ORCA’s success. Volunteers assist ORCA with its monthly programs, plan those programs and solicit speakers, develop and implement marketing efforts and membership drives, serve on its Board of Directors, and provide a wide range of volunteer services that help make ORCA a meaningful and useful resource for its members. Visit our Volunteering page to find out more about how you can help.



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 herefor more info on LifeScience Washington programs and events



FAQ

 

Forgot your login information?

No problem! Simply click on the "Forgot Username/Password" link located under the login window. If you are still having issues, visit our FAQ page for further instructions on how to retrieve your username and password as well as instructions on how to use other popular features on our website.


How do I renew my expired membership? 

Once you type your username and password and click ENTER, the system will prompt you to renew your membership before it gives you access to any of the Members Only menu options. For step by step instructions with screenshots, please visit our FAQ page.


Not receiving important ORCA emails?
ORCA uses a bulk email system to send meeting announcements, registration confirmations, webinar login instructions as well as certificates of attendance. If you have unsubscribed from receiving emails from our system, you will not receive any of these emails. 
To find out how to subscribe again, please visit our 
FAQ page.



Don't remember if you have already registered for a meeting?

Registered attendees can confirm their registration status by checking their Inbox for an Event Registration Confirmation email or by checking their Event History page under their member profile in the ORCA website. Make sure ORCA emails are not going to your Spam or Junk folder. Visit our FAQ page for more information.


Not listed in our Membership Directory?

As per our Terms of Use, some personal contact information of members will be included in the ORCA Member Directory that is made available to each ORCA member unless a member explicitly declines to be included. When you join ORCA, the default Member Directory selection is for some of your contact information to be listed. If you inadvertently changed this option and are no longer listed in our Member Directory, follow the instructions provided in the FAQ page under Membership - How do I update my directory listing selection? to select which information you would like to be listed in our directory.
To opt out of the Member Directory, please follow the 
FAQ instructions under Membership - How do I opt out of the online Member Directory? .

For more answers to frequently asked questions, please visit our FAQ page.


Knowledge Center

Useful FDA educational resources


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

CDRH Medical Device Webinars and Stakeholder Calls

https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/medical-device-webinars-an

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

CDER Meetings, Conferences, & Workshops

https://www.fda.gov/drugs/news-events-human-drugs/meetings-conferences-workshops-drugs

CBER Sponsored Workshops, Meetings & Conferences

https://www.fda.gov/vaccines-blood-biologics/news-events-biologics/workshops-meetings-conferences-bi

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


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


FDA CDER Small Business & Industry Assistance (SBIA)

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


FDA Workshops & Conferences (Medical Devices)

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