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 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
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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)