Breakthrough Device Designation: Understanding Regulatory and Reimbursement Implications Webinar

Join AdvaMed for a webinar focused on the FDA Breakthrough Devices Program and best practices for participation. Hosted by AdvaMed, this webinar will feature presentations from key FDA and CMS staff, followed by an engaging roundtable discussion and Q&A with FDA, CMS and Industry. Webinar attendees will have the opportunity to submit questions upon registration or during the webinar. Registration for the webinar is free for AdvaMed members and government employees. Attendee learning objectives Obtain a comprehensive status update on the Breakthrough Devices Program from FDA and CMS Understand the benefits of participation in the Breakthrough Devices Program Discover best practices directly from FDA, CMS and Industry Recognize the potential payment and coverage implications Who should attend? Regulatory [...]

The Cardiovascular Impact of COVID-19 Webinar

RM Global Partners is convening this event due to the continuing concern about the cardiovascular aspects and risks of the COVID-19 epidemic, even as lockdowns start to recede. The distinguished panel of speakers will answer these questions and more: What have we learned and what can we expect about the cardiovascular impact of COVID-19? What is the clinical impact on trials and product approvals? What was the impact of COVID-19 on the medtech ecosystem? Featured Speakers Dr. Michael R. Jaff (Moderator) is globally recognized as an expert on vascular medicine, having led multiple clinical trials and founded VasCore, the largest international vascular device imaging core lab in the field. He is Chief Medical Officer and VP of Peripheral [...]

Decoding the Development and Launch of a Digital Health Product – From Concept to FDA Clearance

Date/Time: August 26th, 4:00 pm - 5:00 pm PDT Register here: http://uclahs.fyi/biodesign-2021 Event Description: Join UCLA Biodesign for a guest lecture by Paul Upham, Head of Smart Devices at Roche / Genentech, for a discussion on the development of a digital health product at the forefront of technology and breakthrough science. During this talk, you will hear how Roche successfully developed and launched a regulated SaMD product in less than six months as well as the lifecycle of a regulated SaMD product from a regulatory, privacy and security perspective. Speaker Bio: Paul Upham is the Head of Smart Devices at Roche / Genentech. Paul has 20+ years of experience in medical device R&D, strategic marketing, product management, clinical [...]

UCLA Biodesign Informational Webinar

Learn more about the UCLA Biodesign Program and Fellowship. Applications are open now until September 30, 2021. Moderated Q&A with Dr. Jennifer McCaney, Co-Executive Director of UCLA Biodesign and Dr. Nirav Kamdar, Clinical Director of UCLA Biodesign. Visit our website at https://biodesign.ucla.edu/

Navigating Breaks in the Supply Chain and Managing Import Requirements

https://www.biocom.org/EventDetail/?event=Temp-Tuesday-Sept-14

Flight cancellations, closed borders within the EU, and restrictions on peoples movements all formed part of the challenges in importing and delivering clinical trial supplies. Find out how these challenges were overcome and how the industry can be prepared should alterative supply chain routings be needed in the future.

9th Annual UCLA Heart Failure Symposium 2021

https://www.cme.ucla.edu/courses/event-description?registration_id=503254&client_view_p=f

Heart failure affects approximately six million Americans and is the most common diagnosis for acute hospitalization in patients over 65 years. Over the next decade, we will see a dramatic increase in the number of patients in the community with advanced heart failure who can benefit from advanced therapies for complex cardiac disease. Academic medical centers, such as UCLA, have an opportunity to integrate treatment advances into a comprehensive patient-centered heart failure management program. UCLA Health wants to enhance the role of the primary care physician and primary cardiologist as the central provider for continuity of care for these complex heart failure patients. The Ninth Annual UCLA Heart Failure Symposium 2021 will: - Discuss general heart failure treatment [...]

Suds n’ Science Happy Hour with Fisher Scientific

https://www.biocom.org/EventDetail/?event=Life-Science-Happy-Hour

Join Biocom California and Fisher Scientific for networking, drinks, and appetizers at the Twisted Oak Tavern in Thousand Oaks!

Regulatory Affairs Committee Meeting Ft. Dr Jesse Goodman

https://www.biocom.org/EventDetail/?event=rac-meeting-sept-2021

This meeting will include updates on PDUFA/MUDFA, new final and draft guidances, and an opportunity to hear insight from a former top FDA official.

DEI in a Box: PledgeLA Survey Town Hall

https://www.eventbrite.com/e/dei-in-a-box-pledgela-survey-town-hall-tickets-167111632391

PledgeLA’s virtual “DEI in a Box” series gathers leaders from LA tech & VC to tackle specific areas of diversity and inclusion work. About this event PledgeLA presents... DEI in a Box: PledgeLA Survey Town Hall Wednesday, September 22, 2021 - 11:00 - 12:00 PM PT We'll dig into the results of our 2021 PledgeLA survey, unpack emergent themes like racial and gender pay equity or access to capital, and discuss how we can prioritize action. Special Guest Jess Harvie, DEI Strategy Manager, Snap Freesia Chen, Head of People, Fama Technologies Jamie Sullivan, Senior Director of Marketing, Soylent Moderated by: Jasmine Hill, PledgeLA's Scholar-in-Residence and Assistant Professor at UCLA Join us for new insights, an interactive Q&A, and a surprise resource for attendees to help advance [...]

Biocom California’s HR Conference for Life Science

https://www.biocom.org/EventDetail/?event=California-and-Beyond-Life-Science

Biocom California's HR Conference for Life Sciences is dedicated to HR professionals working within the life science industry across the state of California. In 2021, this strategic-level conference will be delivered in a hybrid format. The statewide conference will take place over the span of three weeks, connecting the HR communities across California, and providing a unique opportunity to network and learn from executives and HR colleagues within life science. 

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