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