Standards solve problems. They are universally valued as important and valuable tools to support the design, manufacture, testing, and regulation of medical devices and, as such, play a key role in promoting safety and public health. When manufacturers rely upon FDA-recognized standards, submission documentation is less burdensome and more streamlined.
In this session, Stacy Cho (FDA) and Elizabeth Bladen (USP) will demonstrate the value of standards and explain how to cite them to maximize efficiencies. Stacy Cho, a senior health policy analyst with the Division of Standards and Conformity Assessment Program (DSCA) at the FDA’s Center for Devices and Radiological Health, will discuss how to leverage standards, including in the eSTAR submission platform for medical devices, as well as introduce participants to the FDA’s latest program to enhance standards’ use: the Accreditation Scheme for Conformity Assessment (ASCA). Elizabeth Bladen, the Senior Manager of Regulatory Affairs at USP, will also provide an overview of the United States Pharmacopoeial Convention and highlight how USP’s public standards support manufacturers and the US regulatory framework. The United States Pharmacopeia – National Formulary (USP-NF) includes over 5000 quality standards for medicines, both chemical and biologic; active pharmaceutical ingredients (APIs); and excipients (inactive ingredients).
As the official quality standard for medicines marketed in the US, USP-NF standards help ensure the quality of medicines and their ingredients. While not a government entity, USP works closely with government agencies, ministries, and regulatory authorities around the world to help provide standards of identity, strength, quality, and purity that can help safeguard the global supply of medicines, dietary supplements, and food ingredients.
The event is open to all Regulatory Professionals, as standards are a universal topic. Light refreshments and appetizers will be available for attendees.
Registration Fees & Deadlines
Member $10 | Nonmember $15 | Student $5
The deadline for registration is Sunday, October 20, 2024; there will be no onsite registration. Jazz Pharmaceuticals employees interested in attending should contact Jonas Wilf (Sr. Director, Global Regulatory Strategy, Global Regulatory Affairs, Jazz Pharmaceuticals) directly at
jonas.wilf@jazzpharma.com to register.
Agenda
- 4:30-5:15 PM - Food, networking, and registration
- 5:15-5:30 PM - Welcome remarks
- 5:30-6:15 PM - Stacy Cho (FDA) Presentation
- 6:15-7:00 PM - Elizabeth Bladen (USP) Presentation
- 7:00-7:30 PM - Q&A and Wrap up
Speakers
Stacy Cho, M.A.
Senior Health Policy Analyst with the Division of Standards and Conformity Assessment Program (DSCA) at the Center for Devices and Radiological Health, US Food and Drug Administration (FDA)
Stacy Cho is a senior health policy analyst with the Division of Standards and Conformity Assessment Program (DSCA) at the Center for Devices and Radiological Health. Stacy received her B.S. in Biological Sciences and Psychology from Carnegie Mellon University and received her M.A. in Psychological and Brain Sciences with a focus on fMRI studies from Johns Hopkins University. Stacy started her career at FDA in 2013 after spending several years as a neurophysiologist with hospitals in the DC metro area. At FDA, she served as a lead reviewer for radiological devices with premarket, compliance, and postmarket submissions; and she also led the Third Party 510(k) Premarket Program. Currently, she is the Accreditation Body Lead for the Accreditation Scheme for Conformity Assessment (ASCA) program after spending several years establishing the program.
Elizabeth Bladen
Senior Regulatory Affairs Manager, United States Pharmacopeia (USP)
Liz Bladen is currently the Senior Manager of Regulatory Affairs at the United States Pharmacopeia (USP), where she has worked for 18 years. Liz's career at USP began in 2006 as a librarian and historian. In 2012 she transitioned to a role in compendial operations during which she managed the standards approval processes, volunteer affairs activities, and worked with the FDA to establish and implement USP Pending Monograph Program. After working in the Strategy and Legal division for several years, she joined the U.S. Regulatory Affairs team in 2021. In her current role, she is responsible for working with USP staff to ensure FDA awareness of critical standards-setting activities and leads USP’s Drug Competition Action Plan Program.
Liz holds a Master of Science in Pharmacy from the University of Florida, as well as a Master of Arts and a Master of Library and Information Science from The Catholic University of America. Her diverse educational background, along with her PMP certification and completion of the RAPS Regulatory Affairs Certificate course, provides her with a unique skill set and approach to regulatory affairs. Prior to USP, Liz worked in academic libraries and as a part-time reference librarian for Montgomery County Public Libraries.
Location
Jazz Pharmaceuticals
One Commerce Square
2005 Market St, Ste 2100
Philadelphia, PA 19103
For parking – there is a lot underneath the building as well as self-parking at 1818 Market St, with the entrance on 19th St (2 blocks away). Parking will not be provided or validated.
Sponsors
Jazz Pharmaceuticals, Inc.
Providing the venue as well as refreshments/appetizers.
Platinum Chapter Sponsors
Cancellations and Refunds
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email
RAPS@raps.org