Inside the FDA's New Office in China

Held June 18, 2009

The FDA, under immense pressure from Congress and the public to increase oversight of Chinese firms that manufacture products for drug- and devicemakers, established an office in Beijing last year. Since making the announcement, the FDA has provided little information about what the agency staff is doing there.

Who works in the office? What are the staff’s responsibilities? How are they organized? Are they finding and correcting violations? Is it now more expensive to contract with Chinese companies? Is the FDA slowing down imports?

Get the answers to these and many more questions …

Raymond Bonner of Sidley Austion, will give you the benefit of his interactions with the FDA staff in Beijing as he explains what they do, what they inspect and what they are finding. In addition, he’ll explain what it means now to outsource to, or import from, China. Sidley Austin is the first international law firm to establish astand-alone, comprehensive food and drug regulatory practice in China.

If you ever wanted a first-hand account of what’s happening in China, order now for your entire team to listen in and discover:

  • The mission and organizational structure of the FDA’s China office — including who, what, where, when and how the office operates
  • What the responsibilities of the staff are (inspecting facilities or products ready for export?)
  • Analysis of the regulatory actions and sanctions they have taken or violations they have found to date
  • Drug and device firms’ experiences with the new system
  • Whether the FDA’s actions are making outsourcing to China less cost-effective

Stop wondering what the FDA’s China office is doing and find out from an expert who is there every day.

This audio CD/Transcript is a must for anyone doing business with Chinese suppliers, including:
  • Compliance officers
  • Executive management
  • General/corporate counsel
  • Regulatory/legislative affairs
  • Operations
  • Manufacturing
  • Purchasing
  • QA/QC
  • Outside consultants and attorneys

Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

Raymond Bonner is a partner in the Sidley Austin Washington, D.C. office and is chair of the firm's FDA Regulatory and Enforcement practice. He previously served as a federal prosecutor in the District of Maryland for six years, where he prosecuted major pharmaceutical fraud and GMP cases, and litigated other FDA-related cases. He concentrates his practice on FDA -related cases. He has substantial litigation, enforcement, internal investigation, and compliance experience throughout the life sciences industry, particularly with grand jury and False Claims Act matters. He also counsels pharmaceutical and medical device companies regarding regulatory reporting and submission requirements, GMP/QSR and marketing matters.

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