4:30 PM - 7:30 PM EST
One Commerce Square
2005 Market St Ste 2100
Philadelphia, Pennsylvania, USA, 19103-7002
Sponsor providing the venue as well as refreshments/appetizers
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
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.
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)
Elizabeth Bladen, MS, MA, MLIS,
Senior Regulatory Affairs Manager, United States Pharmacopeia (USP)