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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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UW Biomedical Regulatory Affairs Master of Science (BRAMS) Networking Event


Thursday, March 28, 2019, 6-9 pm, Vista Cafe, Foege Hall next to Medical School, University of Washington

BRAMS is inviting ORCA members to come have a snack and network with rising masters degree students, professors and fellow ORCA colleagues. 

The format is a short panel on career development in an evolving industry, Q&A, then mingling.

Please come share your career advice and job leads with both the next generation of your colleagues and existing specialists.

Contact person: Karen Teal (206) 851-9918 karenkurt.teal@gmail.com

For more information on the BRAMS program see https://www.regulatoryaffairs.uw.edu/

See https://transportation.uw.edu/park/visitor for parking/map details.

Parking in the S-1 Lot is complementary with pre-registration with Karen Teal.


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.



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.

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

Host Application Form

To Be Hosted 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.



Risk-Based Monitoring Essentials Course - Discount Offer to ORCA Members

Cascadia Global Research is offering a 30% discount to ORCA members for their Risk-Based Monitoring Essentials Course. Please email info@orcanw.org to get your discount code.

Read Courtney McBean's article about the three most frequent mistakes companies make by following this link (available to ORCA members only).



LifeScience Washington Programs
Click here for 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, 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 emails for an Event Registration Confirmation email or by checking their Event History page under their member profile in the ORCA website. Visit our FAQ page for more information.

Not listed in our Membership Directory?
Please follow the instructions provided in the FAQ page under New Website - How do I update my directory listing selection?

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

http://www.fda.gov/Training/CDRHLearn/

 

CDRH Medical Device Webinars and Stakeholder Calls

http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm411063.htm

 

CDER Learn

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

http://www.fda.gov/Training/ForHealthProfessionals/

 

CDER Meetings, Conferences, & Workshops

http://www.fda.gov/Drugs/NewsEvents/ucm132703.htm

 

CBER Sponsored Workshops, Meetings & Conferences

Upcoming events

http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm280422.htm

Past events

http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm280537.htm

 

OCTGT Learn

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

http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/ucm232821.htm


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