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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

info@orcanw.org

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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.

Thank you,

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 president@orcanw.org.

Thank you,

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
Register here.

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

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