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Tuesday, Dec. 16, 2008 • 90 minutes
About the event • Key topics • Speakers • Purchase Recording
Featuring
Chen Yang
Partner
Sidley Austin LLP, Beijing
Adrian Emch
Associate
Sidley Austin LLP, Beijing
Live
webinar: $399
Live webinar plus complete audio recording: $499
Audio recording only: $499
Things change fast in China. In the past year, China has overhauled many aspects of its regulatory regime – changes that are having a major impact on how multinational pharmaceutical and medical device manufacturers do business in China. On March 11, the State Council of China announced the merger of the State FDA into the Ministry of Health, meaning that the MOH will now play a key role in regulating the life sciences industry, including coordination of enforcement actions and rulemaking.
For pharmaceuticals, new requirements for electronic tracking of certain products have gone into effect, with possible expansion in 2009 to include all drugs and medical devices marketed in China. SFDA also has issued new guidelines for post-approval manufacturing changes for marketed drugs, a rule describing how the agency and local FDA agencies will conduct inspections as part of the drug approval process, and for the first time a system has been established for drug recalls in China.
For medical devices, SFDA has published its second draft GMP regulations, along with draft certification and inspection procedures for device products. And on July 23 the agency published provisional rules that for the first time imposed joint liability on foreign device manufacturers and their Chinese agents for adverse event reporting, product recall and after-sales service.
In other areas, a new anti-monopoly law entered into force Aug. 1 that forces life sciences companies to pay particular attention to what could be defined as monopoly agreements in China and abuse of dominant market positions.
Are you ready to meet the challenges and opportunities presented by these regulatory changes? Learn what your company must do today to comply with China’s new drug and device regulations and policies. Plus, get a sneak peek at future regulatory changes that are on the way.
Join us for a thought-provoking analysis of this evolving paradigm – live from Beijing. Grab your team, a phone and a computer with Web access (that last one's optional). No travel required.
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Walk
away with guidance in the following areas:
- What to expect from China’s SFDA after its consolidation into the Ministry of Health
- How to ensure your Chinese joint ventures and partnerships do not run afoul of the new anti-monopoly law
- How to ensure your company’s distribution and licensing agreements comply with the anti-monopoly law
- How to prepare for China’s new electronic drug tracking system
- How to manage China’s new drug and device recall systems
- How to prepare for pre-market approval inspections in China given recent regulatory changes
- What future regulatory changes should you monitor and prepare for
... and
much more!
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Chen Yang
Partner • Sidley Austin LLP, Beijing
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here for more information
Chen Yang is a partner in the firm’s Beijing office, where she heads the firm's China Life Sciences Practice. Ms. Yang's practice focuses on regulatory, corporate and commercial law, including Intellectual Property and Antitrust aspects of life sciences matters. Over the last 10 years, she has been advising international companies on their investment projects and acquisition efforts in various Chinese industries, as well as providing them with regulatory advice in areas such as life sciences, intellectual property, employment, tax, and real property. Ms. Yang also assisted P.R.C. government agencies with respect to U.S. litigation.
Ms. Yang also worked for an EU-based firm. Prior to entering private practice, she worked as a legislative official in the Bureau of Legislative Affairs of the State Council, one of China's main legislation drafting bodies.
Ms. Yang received her LLB degree in 1991 from Peking University, a top Chinese university, with the honor of “Best Graduate of the Year.” She received an LLM from the University of Georgia in 1997.
Ms. Yang is admitted to the New York Bar. She is a native Chinese speaker and is fluent in English.
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Adrian Emch
Associate • Sidley Austin LLP, Beijing
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Adrian Emch practices antitrust, regulatory and trade law, with a particular focus on matters related to the European Union and to China.
Mr. Emch has broad experience advising international companies on all aspects of antitrust/competition law, including merger control, coordination of multi-jurisdictional merger filings, cartel investigations, litigation and antitrust counseling on a wide variety of issues.
In addition, Mr. Emch has significant experience in Chinese corporate and regulatory law, including foreign direct investment (FDI).
Mr. Emch has written numerous articles, including "Abuse of Dominance in China: a Paradigmatic Shift?, " European Competition Law Review 615-623 (2008); "The Antimonopoly Law and its Structural Shortcomings," Global Competition Policy Magazine (2008); and "The New Chinese Anti-Monopoly Law - An Overview", Global Competition Policy Magazine (2007) (with Qian Hao) |
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