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Tuesday, June 18 • 3:15pm - 4:15pm
#274: Regulatory Policy Roundtable: Pharmaceutical Quality, Generics, Innovative Medicines

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-606-L04-P; CME 1.00; RN 1.00

Industry leaders will discuss how regulatory and industrial policy can support delivering medicines to patients faster, how to assure pharmaceutical quality for innovative and generic medicines, and how regulatory harmonization benefits both sectors and, ultimately, patients.

Learning Objectives

Define and discuss policy and program updates from FDA's Office of Generic Drugs (OGD) and Office of Pharmaceutical Quality (OPQ); Define quality management maturity (QMM) and how the federal government may use it to improve the quality of medicines and resiliency of the supply chain; Identify policy solutions to quality challenges like nitrosamines, PFAS, and related impurities/chemicals that preserve patient access to safe medicines.

Chair

Aaron Josephson, MS

Speaker

Panelist
Katherine Wilson, JD, MA

Quality Policy Priorities of the Canadian Generic Industry
Kristin Willemsen, MS

Panelist
Brett Howard, JD, PhD


Speakers
avatar for Aaron Josephson

Aaron Josephson

Senior Director, Global Regulatory Policy, Teva Pharmaceuticals, United States
Aaron develops and advocates for policies that enable more efficient and predictable regulatory systems aligned with Teva’s development programs, business objectives, and patient needs. Prior to joining Teva, Aaron worked at FDA for more than a decade in positions at CDER, CBER... Read More →
avatar for Brett Howard

Brett Howard

Senior Director, US Regulatory Policy, USP, United States
Brett Howard is a Senior Director of US Regulatory Policy at the US Pharmacopeia, where he manages USP's regulatory efforts concerning pharmaceutical quality, covering both large and small molecules. Prior to joining USP, he spent the previous decade working for chemical and pharmaceutical... Read More →
avatar for Kristin Willemsen

Kristin Willemsen

Vice President, Scientific and Regulatory Affairs, Canadian Generic Pharmaceutical Association, Canada
Kristin Willemsen is the Vice President of Scientific & Regulatory Affairs for CGPA. She works with CGPA members advocating for the implementation of regulatory, policy and guidance changes to increase access to safe, effective, and affordable generic medicines for Canadians. A key... Read More →
avatar for Katherine Wilson

Katherine Wilson

Head, Global Regulatory Policy and Intelligence, Viatris, United States
Katherine (Katie) Wilson, leads Global Regulatory Policy + Intelligence at Viatris, a global healthcare company committed to empowering people worldwide to live healthier at every stage of life. In her current role, Katie provides regulatory support to drive global policy initiatives... Read More →

Tuesday June 18, 2024 3:15pm - 4:15pm PDT
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Forum |   10: RegCMC-Product Quality, Forum