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Battelle and China Pharmaceutical Association, Beijing, China
December 7-11, 2006
The Chinese Pharmaceutical Association (CPA) invites the international community to participate in this first symposium in China in this very exciting arena of biopharmaceuticals and the market. We will consider opportunities and challenges for the China Pharmaceutical Association members and for the international community.
Purpose
Introduce Small and Medium Size Western Biotech firms to the Chinese Biopharmaceutical Industries and their Capabilities and Capacities for Product Development and Manufacturing.
With increasing concern on the possibilities of emerging infectious diseases, bioterrorism events and natural disasters, do we have access to needed product (API)? Do we have a market for our product, what can we do to sell our product in all markets and ensure we have enough product to sell?
Objective
Bring together professionals from industry, government and academia who are most concerned and involved in the technical, scientific, medical and legal aspects of the processes associated with research and development, drug discovery, and developing and bringing biopharmaceuticals and pharmaceuticals to market. This area includes standards, trade practices, case studies as well as distribution/networking, market development internal to and external from China, Chinese and non-Chinese product, bulk product, and an exploration of the benefits of stable supplies of active pharmaceutical ingredient (API). Contributions of papers and posters from each area are solicited.
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Organized by:
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Battelle, China Pharmaceutical Association, CPA and Applied Science and Analysis, ASA |
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Invited Speakers:
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Proposed Baskets of Major Topic Areas
Guide for Proposed Papers: (Baskets and sub-areas will be added in each ASA Newsletter issue as well as in ICBS network updates. The ICBS Executive/Science Review Committees are open to suggestions for additional topic areas).
1. The Regulatory Process
a. US, EU, Near/Far/Mid East, Pacific Rim;
b. Glossary/Terminology
2. Standards
a. International, Chinese;
b. Requirements for GMP (US/EU)/ISO; and,
c. QA/QC
3. Business - Opportunities and Challenges
a. Distribution, Networking, Collaboration;
b. Strategic Partnering and Alliances
c. Funding clinical development;
d. Modernization of Facilities;
e. Market Development China
a1. Internal China
a2. Worldwide from China
a3. Bulk Product via 3rd Party
a4. Active Pharmaceutical Ingredient (API), Chinese capabilities to meet rapidly developing international requirements
f. Market Development in China for non-Chinese Product;
g. Product Launch in China
4. Trade Practices
a. Legal Issues: IP/Enforcement;
b. Trade Rep (US/EU/Other) ;
c. Outsourcing Services to include clinical trials
1a. Advantages to non-China biopharmaceutical - such as reduced costs and time, large patient population
2a. Advantages to China biopharmaceutical -
5. Pre-Clinical Testing
a. Appropriate Animal Models and End Points for Efficacy
b. GLP Safety/Efficacy Testing; and,
c. Biomarkers
6. Emerging Infectious Diseases
a. Vaccines; b. Anti-virals;
c. HPAI, SARS
7. Natural Products (Traditional Chinese Medicine [TCM])
a. Regulatory Roadblocks and Funding Implications
8. Biopharmaceuticals
a. Vaccines & Adjuvants: Types (include DNA), Targets
b. Antibodies and
c. Therapeutics (include Cancer);
d. Immunomodulation (Modes/Routes/Delivery)
e. Diagnostic Reagents
9. Case Studies
a. Drug Development and Manufacture;
b. Distribution, Networking
Contact info@icbps.org for further information.
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Deadline for Abstracts:
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www.icbps.org
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Registration:
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to be supplied
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E-mail:
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info@icbps.org
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