Special Election Result and New Officers Announcement
Congratulations to Elena Kuzmenko for being elected to the ORCA Board.
The full board of directors held its first meeting after the election. For the 2019-2020 year, Elizabeth Cross Nichol will be the President of ORCA, Albert Nakano will be the Treasurer of ORCA, and Judy Buckham will be the Secretary of ORCA.
It has been my privilege to have served as your President for three years. I count among the successes the introduction and expansion of the webinar meetings, reconnecting with the UW BRAMS program, and welcoming back speakers from the FDA.
My goal going forward is to play a supporting role as the Treasurer and provide logistical support at our various meetings. I hope we can see more relationships develop at meetings and foster a sense of community for our professional and student members.
Albert H Nakano, Past-President
On ORCA membership’s behalf, I wish to thank Albert for his years of service. We are delighted that he will remain involved with the Board.
I am pleased to serve ORCA. With your assistance, we can continue to provide a regional forum to facilitate education, networking and support in the professional and technical aspects of regulatory, quality and clinical functions. Please have a look at our Volunteering opportunities.
All of us working together make ORCA stronger. I look forward to hearing any thoughts you have at firstname.lastname@example.org.
Elizabeth Cross Nichol, President
Free QServe Webinar - 10 Facts You Need to Know Now to Prepare for the IVDR
This 1-hour webinar will provide the answers to the pressing questions Senior Level Executives are asking as IVD manufacturers are preparing for the next major impact to EU Regulation and how this will affect the entire industry in 2022.
With the IVDR drawing near, Sue Spencer will cover the 10 KEY facts that executives need to know now and how it will affect your entire organization. The introduction of the IVDR is described as a cultural shift because it impacts so many parts of the business. If you think this only impacts quality and regulatory you need to listen to this webinar! Being prepared early could save you a lot of resources and money and the presentation will answer some very tough questions.
Monday , December 9, 2019
7:30 AM - 8:30 AM PST
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 email@example.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
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.
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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.
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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?
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.
Useful FDA educational resources
FDA’s Center for Devices and Radiological Health (CDRH) web page for multimedia industry education
CDRH Medical Device Webinars and Stakeholder Calls
The web page for educational tutorials offered by the Center for Drug Evaluation and Research
CDER Meetings, Conferences, & Workshops
CBER Sponsored Workshops, Meetings & Conferences
The Center for Biologics, Evaluation and Research's (CBER) Office of Cellular, Tissue and Gene Therapies (OCTGT) web page for industry education.
The Robert J. Margolis, M.D. Center for Health Policy
Calendar of Events
FDA CDER Small Business & Industry Assistance (SBIA)
FDA Workshops & Conferences (Medical Devices)