OCRA Presents: Organizing Chaos

Enterey 200 Spectrum Drive #220, Irvine

-- -- Questions? Contact program@ocra-online.org OCRA’s non-profit Federal Tax ID# 33-0630455 The name used on registration will be used on the certificate

OCRA Holiday Hospitality 2021

Tavern House 333 Bayside Drive Newport Beach, CA. 92660

Celebrate a great year with OCRA!
Enjoy Holiday Cocktails, Hors d’ Oeuvres & a Harbor View Dinner, followed by a short walk to view the Newport Beach Decorated Homes, and the Boat Parade as it passes by!

$5

OCRA Meet & Greet

slaters 50/50 Slater's 50/50 17071 Beach Blvd. Huntington Beach

    OCRA Bacon - Burgers - Beer @ Slater's 50/50 Join OCRA for a sports networking event on Thursday, November 11, from 5.00-8.00pm! Make sure to invite your co workers and friends!  

Free

DeviceAlliance: 2021 MEDTECH MONTH MIXER

DEVICEALLIANCE THE GREATER IRVINE CHAMBER OF COMMERCE AND OCTANE OC PRESENT THE MEDTECH MONTH MIXER!   REGISTER HERE   For decades, California’s medical device and life science industry has had profound impacts on patients and their families around the world.  We invite you to come and celebrate a renewed focus...

Annual Event: Exploring Emerging Technologies

Visit the ANNUAL EVENT website HERE.   To REGISTER for this Event, please click HERE. You will be taken to The 2021 OCRA Annual Event Eventbrite Registration page.

Clinical Supply Chain Management: Dude, Where’s My Patient Benefit?

Clinical Supply Chain Management: Dude, Where's My Patient Benefit? Program Speaker: Dr. Lequina Myles, DRSc, MS, MBA, RAC, PMP, PMI-ACP Senior Director of Quality Assurance and Regulatory Affairs Phenomenex (a Danaher Company) GO TO THE SDRAN WEBSITE     Event Agenda: Date: Wednesday, 15 Sep...

Business of Healthcare

Online

Do you have a novel biotech idea but need help bringing it to market? What regulations may impact your product development? How much money will you need and where to raise it? Which ideas investors fund and why? And finally, how do you convince healthcare providers and patients to use your invention? OCRA has partnered with the Small Business Development Center (SBDC)@UCI Beall Applied Innovation to present a Business of Healthcare event. Local entrepreneurs, investors, marketing strategy experts will share their valuable knowledge and real-life experiences in what it takes to turn an idea into a successful venture. Understand the correlation between risk management, clinical evaluation, and other post market surveillance activities to ensure the necessary linkages and references needed in multiple QMS procedures in order to comply with new Global Regulatory expectations

$10 – $25

DEVICEALLIANCE: PROVING YOUR DEVICE WORKS IN THE REAL WORLD

You’ve got a great idea for a medical device! Now what? Most errors in clinical trials are a result of poor planning. Fancy statistical methods cannot rescue design flaws. Thus careful planning with clear foresight is absolutely crucial for clinical trial success. With the explosion...

IVDR Implementation: Key Considerations Amidst the Looming Deadline

Online

As the IVDR implementation looms closer this program will provide valuable feedback and lessons learned from two thought leaders that are working closely on multi-product IVDR certifications. The program will address most recent developments of IVDR, including a status update about notified bodies and implementation deadlines. We will address possible points of confusion between MDR and IVDR as well as share best practices and pitfalls to avoid.

$10 – $15

Risk Management

Online

Emerging Technologies and Combination products can advance patient therapy by combining and utilizing innovative technologies to deliver treatment. Although these products can be beneficial and lifesaving to the patient, industry may find it difficult to develop and maintain a sound, consistent approach to lifecycle management. Industry is keenly aware that the key to ensuring quality and safety in the lifecycle of a combination product is effective risk management.

$10 – $25

SDRAN: FDA Promotional Materials Submissions in eCTD Format

Online Webinar

FDA Promotional Materials Submissions in eCTD Format Program Speaker: Rachel Bombara Sr. Regulatory Operations Specialist Certara Synchrogenix REGISTER HERE   Event Agenda: Date: Wednesday, 21 July 2021 Time*: 5:30 - 6:00 PM Virtual Networking 6:00 – 6:05 PM Welcome and Announcements 6:05 – 7:05 PM...

No Finger Sticks! Best News Ever!

Online

U.S. Food and Drug Administration granted Dexcom a De Novo request for the Dexcom G6® CGM System, the newest generation of CGM for people with diabetes ages 2 and up. The purpose of this presentation is to share best practices around expanding an indication to include pediatrics. Coupled with providing a simple and effective ecosystem for parents & caregivers meant improved diabetes management for children and reduced finger sticks. The Dexcom G6 is indicated by the FDA for use as both a standalone CGM and for integration into automated insulin dosing (AID) systems.

$10 – $25

SDRAN: Health Economics & Reimbursement 101: Dispelling Common Market Access Myths

Online Webinar

Health Economics & Reimbursement 101: Dispelling Common Market Access Myths (US Market / Medical Device Focus) Program Speakers: Greg Schneider, MBA Senior Advisor in Reimbursement & Market Access TTi Health Research & Economics & Avijeet Chopra, Ph.D., MBA HEOR Senior Associate TTi Health Research &...