Dr. Liang Zhou
25+ years’ experience in RA and QA of pharmaceutical industry
Ph.D., Vanderbilt University
• Former VP of Strategic Global Medicine & Regulatory Policy at QILU Pharmaceutical CO., LTD;
• Former Chairs of US FDA technical committees, 21 years’ review experience in CDER;
• Specialized in global scientific and regulatory issues, extensive experience covering generic drugs, new drugs, biologic products and biosimilars.
Mr. Jack Hong
General Manager of BaiPharm
13 years’ experience in RA and R&D of pharmaceutical industry
• MSC of Pharmaceutical Engineering, Zhejiang University Expert knowledge of pharmaceutical regulations and industry practices, strong practical experience;
Lead 4 drug programs from product R&D phase to market approval;
• Project manager of 10+ ANDA registrations (China & USA);
• 100+ product feasibility research projects.
Mrs. Mona Zhang
Regulatory leader with 8+ years’ consulting experience
MSC of Biochemistry Engineering, Zhejiang University
• 8+ years of regulatory consulting experience in areas of industrial chemicals, cosmetics and pharmaceuticals in AP, familiar with MEE and NMPA regulations and guidances;
• Toxicologist accredited by Chinese Society of Toxicology;
• Project manager of 100+ registration projects.
Mr. Robert Kiefer
25+ years’ Regulatory Affairs experience in the chemical and formulated products industry
General Manager, US Office
MSC of Biology, James Madison University
• Served as Director of Regulatory and Technical Affairs for the American Chemistry Council (ACC).
• Served as Director of Scientific and International Affairs for the Consumer Specialty Products Association (CSPA);
• Extensive regulatory advocacy experience in domestic and global chemical control regulations, trade policy, hazard communication, consumer products and pesticides.
• Extensive industry and government contacts from networking with US and international companies, trade associations, government regulatory agencies, and non-government organizations.
Dr. Shannon Gainey
16 years’ project and industry experience providing regulatory compliance support for Multi-national companies
Technical and Regulatory Director, US Office
Ph.D., Chemistry, University of North Carolina
• Extensive experience supporting the global chemical compliance requirements for industrial chemicals, food/food packaging and cosmetics/cosmetic ingredients
• Expert in global hazard communication regulations, hazardous materials regulations and global chemical control laws
• Project leader advising multi-national companies on regulatory strategy, providing testing oversight, preparing dossiers and communicating with regulatory Authorities to support submissions
• Project team lead for the implementation of GMP compliance requirements under the US FDA’s Food Safety Modernization Act (FSMA) for food ingredient at company manufacturing site
• Serve as liaison and communicate with regulatory agencies to support client regulatory submissions (e.g. US EPA, US FDA, Environment and Climate Change Canada and Health Canada).