2023 Spring Symposium
June 1, 2023
Opportunities and Challenges:
Pilots and Projects in the Oncology Center of Excellence
Speaker: Linda Bowen, M.S, RAC, FRAPS,
Executive Director and Head of the Regulatory Centers of Excellence - Seagen
FDA's Oncology Center of Excellence (OCE) was created under the 21st Century Cures Act of 2016 and launched in 2017, with the goal of uniting “experts across the FDA to conduct expedited review of medical products for oncologic and hematologic malignancies.” The Center, which sits in the Commissioner's Office, is the first intra-center function at the agency.
Since its inception, OCE has been known for various initiatives, including projects and pilot programs, some that you might be familiar with including the Real Time Oncology Review, Project Orbis, Project Front Runner, Project Optimus and Project Equity. This presentation will highlight the opportunities and challenges presented by these initiatives and take a look at how they have changed the way we look at oncology drug development.
SPEAKER BIO: Linda Bowen has 40 years-experience in the BioPharma Industry, of which 30 years were spent in regulatory strategy, intelligence and policy roles. She is Executive Director and Head of the Regulatory Centers of Excellence at Seagen, Inc. and has also been an assistant adjunct professor in the Temple RAQA Master's Program for the last 25 years.
She attained regulatory affairs certification for the US, Canada, and Europe, and was an inductee into the 2011 Class of RAPS Fellows. Linda was honored with the Drug Information Association's 2012 Excellence in Volunteer Leadership, the 2019 Americas Inspire Awards, and the 2022 Global Inspire Award - Community Engagement as well as the RAPS 2020 Founder’s Award.
She is a past two-term member of the RAPS Board of Directors and current Chair of the Affiliate Board. She helped start the NJ NY RAPS Chapter in April 2003 and has been a part of the chapter leadership team since that time. Linda chairs the DIA Regulatory Affairs Community and was founder of the DIA Regulatory Intelligence Working Group. She sat on the planning committee for 2013-2017 DIA Annual Conference, the 2011-2017 RAPS Annual Convergence and was Program Chair for the 2018 & 2019 RAPS Annual Convergence.
She is most proud of her role as an educator and mentor to those entering the regulatory profession.
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This event includes dinner and will be IN-PERSON ONLY
Members - $40; Non-Members - $60
(students, post-docs, and unemployed are discounted at checkout)
Networking and Drinks: 5:30 - 6:30 pm
Dinner: 6:30 - 7:30 pm
Presentation: 7:00 - 8:00 pm
LOCATION
DoubleTree by Hilton Hotel Raleigh-Durham Airport at Research Triangle Park
4810 Page Creek Ln, Durham, NC 27703
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Registration for the 2023 RAC Workshops are open!!
You must be a member to register (membership is currently $20).
Workshop registration is $75
The Pharm/Bio Workshop for 2023 will be Hybrid: all sessions will be by zoom (and recorded for later viewing),
with most in-person as well (Zoom link is in the confirmation email)
Live sessions in this series will be held Tuesday evenings, 6-8pm, from May 30 to September 26
Location: IQVIA at Innovation Center, 2400 Ellis Rd, Durham, NC 27703.
This workshop series is a comprehensive overview of regulatory requirements for development, manufacture, marketing and compliance for drug and biological human medicines in the US, EU, and other countries. It is especially useful for those studying for the RAC (Drugs) certification exam, but also is valuable for anyone interested in learning more about WHY the industry operates as it does. Each session in the series features a lecturer with relevant industry or other "field" experience to illustrate the concepts discussed.
NCRAF will NOT host a live version of the 2023 RAC Device Workshop.
With registration, you will gain access to the recordings of the 2022 Device Workshop.
The link to view the recordings and slides will be found in your confirmation email.
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Membership dues for 2023 will continue to be $20 for the year.
When your membership renewal comes up during the 2023 calendar year, you will receive, via email,
an invoice for $20.
Please pay via the invoice (there's a link in the email),
the old "log in to the website and renew" is no longer available.
