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Breakthrough Medical Devices
Wednesday 13 November 2019, 03:00pm - 06:00pm
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You are invited to an Afternoon Meeting

 

Networking and Educational Opportunity

 

Breakthrough Devices Program

Speeding patient access to novel medical devices and technologies.

 

November 13, 2019

3:00 – 6:00 pm

 

Join In Person or On Webinar

 

Online Registration: https://www.eventbrite.com/e/breakthrough-devices-program-tickets-75626999391

 

3 Hours Towards Your RAPS RAC Recertification

 

Location:  

Alcon, 15800 Alton Parkway, Irvine, CA 92618

 

Host:

Veronica Arellano, Sr. Medical Product Information Specialist II, Alcon

 

Program Managers and Moderators:

Shepard Bentley, President, Bentley Biomedical

Paul Kramsky, Independent Regulatory Affairs Consultant

 

Presenters and Panelists:

Paul Kramsky, Independent Regulatory Affairs Consultant

John Doucette, Neuroscientist, Policy & Operations Team, Office of Clinical Evidence & Analysis, FDA

Allison Komiyama, Ph.D., RAC, Owner and Principal Consultant, AcKnowledge Regulatory Strategies         

Omid Khodai OD, MS, RAC, CQA, CQM/OE, President, Khodai Consulting

 

 

Schedule of Presentations:

 

3:00 – 3:30 pm           Check-In, Networking, and Refreshments

 

3:30 – 3:50 pm           Overview of the Breakthrough Devices Program

Speaker – Paul Kramsky, Independent Regulatory Affairs Consultant

 

3:50 – 4:25 pm           FDA’s Experience with the Breakthrough Program

Speaker – John Doucet, Ph.D., FDA/CDRH

 

4:25 – 4:40 pm           Break, Networking, and Refreshments

 

4:40 – 5:15 pm           Industry’s Experience with the Breakthrough Program

Speaker – Allison Komiyama, Ph.D., RAC, AcKnowledge Regulatory

 

5:15 – 6:00 pm           Q&A, Panel Discussion, and Closing Remarks

 

Synopsis:

The Food and Drug Administration has implemented a program to speed patient access to new medical devices or technologies that perform a more effective treatment, incorporate novel technology, or are like nothing else on the market. The program, referred to as the Breakthrough Devices program, supersedes and combines several of the agency’s existing programs to speed patient access to a new medical device or technology without compromising safety and effectiveness.  Qualifying devices granted breakthrough designation are afforded several advantages that include interactive and timely communication with FDA, efficient and flexible clinical study design, senior FDA management engagement, and priority review.  This OCRA program will cover the basics of the Breakthrough program and feature presentations by both industry and FDA speakers on their respective experiences with the program, along with helpful tips (do’s and don’ts). The program will end with a panel discussion on the challenges of meeting the most critical of the program’s qualifying criteria.

 

Please join us for these learning opportunities and open discussions with seasoned industry and FDA professionals.

 

Cost:

OCRA Members: $60 in-person attendance or $40 webinar* attendance

Non-Members: $135 in-person attendance or $115 webinar* attendance (includes OCRA Membership fee)

Government and Students in-person attendance: $35 for members or $70 for non-members (includes OCRA Membership fee)

Government and Students webinar attendance:  $20 for members or $55 for non-members (includes OCRA Membership fee)

FREE for Alcon Employees (please register for the Free ticket option on EventBrite)

 

If you have any questions or require additional information, email OCRA Program Chair (This email address is being protected from spambots. You need JavaScript enabled to view it.).

 

Registration deadline is November 6th.  No same day (in-person or webinar) or on-site registrations will be allowed.  You must register for this event using EventBrite:  https://www.eventbrite.com/e/breakthrough-devices-program-tickets-75626999391

 

No multiple ticket purchases please.  Please purchase one ticket at a time and use the attendee’s name in order for that person to be listed on the security check-in list.

 

*Webinar attendees: Email This email address is being protected from spambots. You need JavaScript enabled to view it. by November 12th for a link to the webinar.


 

Speaker and Panelist Bios

 

 

John Doucette, PhD, is a member of the Policy and Operations Team in the Office of Clinical Evidence and Analysis within the Center for Devices and Radiological Health.  John is the lead policy analyst responsible for oversight and management of the Breakthrough Devices Program.  He received a B.S. in Biomedical Engineering and a PhD in Neuroscience from Syracuse University.  Prior to joining the FDA in 2008, John spent 13 years at Johns Hopkins University as a basic research scientist studying the brain mechanisms that underlie hearing.  Since joining the FDA, he has served principally as a lead reviewer for premarket submissions that describe new devices intended to treat neurological and psychiatric conditions.  He has also served in temporary roles (3 months – 1 year) as an FDA policy analyst, Branch Chief, and as the Director of the IDE Program. 

 

Allison Komiyama, Ph.D., RAC, is owner and principal consultant for AcKnowledge Regulatory Strategies, a consulting firm that develops regulatory strategies and submissions for medical device and IVD manufacturers. Her work has focused mainly on US regulations, with a specialty in pre-submissions, 510(k) notifications, de novo applications, IDEs, and 513(g) submissions. After her education in molecular biology and neuroscience, Allison moved to DC to work at FDA as a reviewer in the Office of Device Evaluation (ODE). She acted as a lead reviewer for premarket submissions and was a consult for files evaluating the biocompatibility of patient-contacting devices. After her time at FDA, she worked as a project manager and regulatory affairs manager at an IVD company in Poway, CA, and then as a senior regulatory specialist at a consulting company in Del Mar. She started AcKnowledge Regulatory Strategies in 2014 in order to serve medical device manufacturers who are seeking regulatory support and FDA approval/clearance. She was certified by RAPS in 2014 and works with a team of 7 people in Old Town, San Diego. 

 

Omid Khodai OD, MS, RAC, CQA, CQM/OE, is President of Khodai Consulting, a clinical and regulatory consulting firm.  Prior to being a consultant, he served as Director of Clinical Research at Boston Scientific. In this role he led the clinical team to design and execute the company’s clinical trial strategy to produce a clinical evidence-base for regulatory, reimbursement, and commercial positions. He also served as Global Head of Clinical and Medical Affairs at STAAR Surgical, including successful approval of FDA Advisory Committee. He also served as Executive Director of Clinical and Medical Affairs and Scientific Communication at Bausch and Lomb where he successfully led the organization to approval of FDA Advisory Committee and commercialization of first of kind product as well as successful integration of a $5 Billion business through acquisition.

 

 

OCRA Registration Instructions

 

In-person registration fee includes light snacks, beverages, free parking and access to electronic presentations after the meeting (if approved by speaker for distribution).    

 

To register for this event go to: https://www.eventbrite.com/e/breakthrough-devices-program-tickets-75626999391

 

Registration deadline is November 6th.  No same day (in-person or webinar) or on-site registrations will be allowed.  You must register for this event using EventBrite. 

 

No multiple ticket purchases please.  Please purchase one ticket at a time and use the attendee’s name in order for that person to be listed on the security check-in list.

 

*Webinar attendees: Email This email address is being protected from spambots. You need JavaScript enabled to view it. by November 12th for a link to the webinar.

 

 

OCRA's non-profit Federal Tax ID# 33-0630455

 

 

Cancellation Deadline:

For a refund, please email your cancellation request to OCRA Program Chair (This email address is being protected from spambots. You need JavaScript enabled to view it.) by November 12, 2019.

 

If you have any questions or require additional information, email OCRA Program Chair (This email address is being protected from spambots. You need JavaScript enabled to view it.).

 

Location Alcon
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