Biolake and Wuhan SFDA: Regulator’s Perspectives of the Proliferative Bio-industry in Central China
Hosted by MIT CSSA and CABA
A Presentation and Panel Discussion from 武汉市食品药品监督管理局(Wuhan SFDA) Saturday, August 28, 2010 9:00am – 12:00pm E51-315 (same building as the Tang Center), MIT, 182 Memorial Drive, Cambridge, MA 02139
Agenda
9:00 – 9:30am Registration (free to members of the hosts and sponsors, donuts and coffee provided) 9:30 – 9:45am Openning Remarks (Shiwen Lin, Ph.D., Wendy Zhang, Ph.D.) 9:45 – 10:45am Presentation (Xiaomin Laura Bi, MD, Deputy Director) 10:45 – 11:45pm Panel Discussion (Xiaomin Laura Bi, Xinhong Hedy Li, Guang Wolf Feng, Bin Albert Hu, Dequn Toby Zhang, Bo Bob Yang) 11:45 - 12:00pm Networking
Wuhan, China: Where history meets modern times; where east meets west, north meets south; where Yangtze River meets Central China Plain; where intellects meet entrepreneurs; where new businesses meet investment. Where pharmaceutical and biomedical industry meet regulators services.
Saturday, August 28, 2010 9:00 – 12:00pm E51-315 (same building as the Tang Center), MIT, 182 Memorial Drive, Cambridge, MA 02139
专业培训团成员: 秘效敏 Laura BI Wuhan FDA, Deputy Director 张德群 Toby ZHANG Wuhan FDA, Section Chief 李新红 Hedy LI Wuhan FDA, Chief Section Member 杨 波 Bob YANG Wuhan FDA, Vice Section Chief 胡 兵 Albert HU Wuhan Institute for Food and Drug Control, Vice Section Chief 冯 光 Wolf FENG Wuhan Institute for Food and Drug Control, Vice Section Chief
Co-Sponsors: 留美华人企业家协会Overseas Chinese-American Entrepreneurs Association (OCEAN) 北美中华医学会American-Chinese Medical Association (ACMA) 中美知识产权法律协会Chinese-American Intellectual Property Law Association (CAIPLA) 纽英伦中华资讯网络协会New England Chinese Information & Networking Association (NECINA) 武汉大学校友会Wuhan University Alumni Association 华中科技大学校友会 HUST Alumni Association 同济医科大学校友会TJMU Alumni Association
* Members of hosting organization, when you register @ Evite, please indicate your organization (ACMA, CABA, CAIPLA, NECINA & OCEAN) in the "add your comment" section.
Contact: If you have any questions, please contact the following organizers from your organizations.
Volunteers Needed: We welcome ice cream donation and volunteers for preparing this summer event - please contact Pingping Kuang (ppkuang@bu.edu) (ACMA), Ling Huang (linghuang2001@gmail.com) (OCEAN) or Zhiyong Yang (zyyang02@yahoo.com) (CABA), if you can help. We look forward to seeing you at the Hopkinton State Park.
(1)Safety is your responsibility, event organizers will not be held liable for any personal injuries or property damages; (2)bring your outing gears (sun lotions, swimming suits, fishing rods, folding chairs, umbrellas, hats, bikes, blankets, etc); (3)the Park charges $5 per vehicle for parking.
3rd Annual Pharmaceutical and Biotechnology Pioneer Forum (PBPF2010) “Outsourcing, Partnering, Licensing & Deal Making”
September 16 to 17, 2010
Shanghai, PRC
Co-organized by Chinese-American BioMedical Association(CABA).
Who should attend:
Presidents, Vice Presidents, Directors, Senior Managers, Managers and Scientific Officers in charge of:
·Global Licensing / Business Development / Corporate Strategy / Strategic Alliance / Mergers and Acquisitions
·Research & Development / External Innovation / External Research / Global Sourcing
·Clinical Trials / Pre-clinical Development
·Intellectual Property & Patents
·Sales and Marketing
As China ’s definitive event forging pharma-biotech-academia-CRO worldwide partnerships, PBPF2010 will:
·Bring together 500+ senior level representatives from big pharmasrenowned research institutions, world's most promising biotech companies and top CRO companies , including Novartis, Pfizer, Merck, J&J, Amgen, Roche, AstraZeneca, BMS, Lilly, GSK, Takeda, Baxter and more
·Discuss hot topics: innovation & licensing opportunities, preclinical & clinical developments, diagnostics & molecular biomarkers, personalized medicine opportunity, next generation antibody & protein therapeutics & more, providing global participants with the unique platform to review, examine and take advantage of these key issues
·Help to fuel your company's dynamic growth in China
CABA 2010 Pharmaceutical/Biologic/Medical Device Regulatory Affairs Training program
The 2010 Pharmaceutical/Biologic/Medical Device Regulatory Affairs Training program is designed to focus on regulatory affairs in biotechnology, pharmaceuticals, medical device as well as drug development perspectives, commercialization, and post-marketing management.
The following is a list of topics included for the training program of 2010: 1.Regulatory Affairs in US Biotechnology/Pharmaceutical Industry and International Regulations, Basic cGMP & Case Studies. 2.The FDA’s Fundamental Functions: Creating and Enforcing New Regulatory Standards 3.The FDA Field Office: Roles, Responsibilities, and Agents for Change. 4.Drug Safety and Reporting, Off-label Use - Regulations from a Clinician’s Perspective. 5.Food Regulation and Drug Regulation: Resemblances and Difference 6.FDA Regulation Medical Device. 7.FDA regulatory of Medical Device Quality Systems and Post Market Surveillance. 8.Post-marketing Safety Management: Adverse Effect Reporting and Product Recall 10. FDA Updates and CGMP Practice in Pharmaceutical Industry – Overview 11FDA Inspections and 483s Analysis – Overview 12.Chemistry Manufacture and Control, and Drug Master Files – Overview 13.New and Generic Drug Product Development Process – Overview 14. Product Expectations for CROs (Contract Research Organizations) – Overview 15.Establishing Efficient Quality Systems to Ensure Drug Safety and Compliance: Strategies for Pharmaceutical and Biotech Companies 16.Setting Up Efficient and Compliant Quality and Monitoring Systems: Independent and Third‐Party Roles and Responsibilities. 17.Quality-By-Design 18.Quality system regulation and case contamination study 19.Quality Systems and Compliance Development for Human Somatic Cell Therapy Products: Lessons Learned from 19 Years of Experience. 20.Generic Drug Development and Regulations 21.Pharmocovigilance 22.Intellectual Property in the Biotechnology/Pharmaceutical Industry.
Length: 10 weeks
Detailed program: Section 1: July 19 – August 8 Courses: 2 hour classes, 3 times/week; from 7:00-9:00PM
Section 2: August 16 – September 5 Courses: 2 hour classes, 3 times/week; from 7:00-9:00PM A few of classes take places in daytime.
Section 3: September 22– October 8 Courses: 2 hour classes, 3 times/week, 7:00-9:00PM
Section 4: October 9 - October 14 Summary, Report, and Certificate awarding.
Located in the center of Bohai Bay, Tianjin is one of the four municipalities under direct jurisdiction of the central government and the largest coastal city open to the outside world in northern China. Tianjin Port Free Trade Zone (TJFTZ) is the largest free trade zone in northern China. Tianjin Airport Economic Area (TAEA) is an extended area of TJFTZ. They are core parts of Tianjin Binhai New Area, facing northeastern Asia and serving 13 provinces and municipalities in China.
Biomedical industry is one of Tianjin’s pillar industries and the fastest growing hi-tech industry. Tianjin has 52 universities and 230 technical colleges with talented faculty and students. As the core center of TAEA’s Bio Valley, Tianjin Institute of Industrial Biotechnology, Chinese Academy of Sciences (TIB, CAS) was established by CAS and Tianjin in March of 2009 focusing on developing industrial bio-technology systems and promoting a sustainable development of Tianjin and the Bohai Rim. The main goal of TIB is to facilitate the integration and transformation of industrial biotechnology with cGMP standard and to promote high-tech industrialization through its Innovation and Incubation Center.
A delegation, led by the US Office of Tianjin Free Trade Zone, will be visiting Boston to meet you and explore potential collaborations on July 17.
Article ID : 75