American Conference Institute (ACI) will be holding a China Pharmaceutical Regulatory Law Boot Camp on April 22, 2014 in New York, NY. ACI faculty will help attendees:
• Explore the swiftly evolving landscape of Chinese pharmaceutical regulation and law;
• Understand the structure and role of the new Chinese Food and Drug Administration (CFDA);
• Minimize regulatory risk when doing business in an atmosphere of heightened enforcement in China;
• Master the essentials of the CFDA drug and biologic approval process and navigate the burgeoning Chinese biosimilars market;
• Comprehend the regulatory / patent interface including exclusivities for biopharmaceutical products in China;
• Conduct safe and effective clinical trials in China under the current legal framework and work with local partners and CROs;
• Examine and comply with Chinese and U.S. cGMP regulations in the drug and biologic manufacturing process; and
• Understand Chinese pharmacovigilance requirements and identify potential consequences for non-compliance.
In particular, ACI's faculty will offer presentations on the following topics:
• A Helpful Guide for Regulatory Professionals Doing Business in China in an Atmosphere of Heightened Enforcement
• Brave New World: Exploring the Swiftly Evolving Chinese Pharmaceutical Regulatory Landscape
• Mastering the Essentials of the Drug Approval Process in China: Exploring the Necessary Steps and Pathways to Bring a Drug to Market
• Developing Biologics and Biosimilars in China: A Regulatory and Patent Cheat Sheet to Minimize Risk and Maximize Opportunity
• Conducting Safe and Effective Clinical Research in China: Avoiding Potential Enforcement Risks and Ensuring Safety and Data Integrity in Clinical Trials
• Appreciating the Complexities of Intellectual Property Protection of Pharmaceutical Products in China and Demystifying the Patent / Regulatory Interface
• Pharmacovigilance in China: Navigating the Protocols of Adverse Events Monitoring in Compliance with Global Safety Standards
• Creating a Culture of cGMP Compliance in China: Meeting Chinese and U.S. cGMP Standards for Certification in the Drug Development Process
An agenda for the conference can be found here, and a complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.
The registration fee is $1,795 (law firm rate) or $1,595 (in-house rate). Those interested in registering for the conference can do so here, by e-mailing [email protected], by calling 888-224-2480, or by faxing a registration form to 877-927-1563.
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