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Date(s) And Time(s):
Sep 18 2006 8:30AM - Sep 19 2006 5:00PM
Location:
Westin Princeton at Forrestal Village
201 Village Boulevard
Princeton, NJ 08540
Overview:
The conference aims to provide a detailed analysis of what it takes to conduct clinical trials in China and India, and will address: risk/benefit balance; anecdotal experiences of the multinational pharmaceutical industry in China and India; selection and role of CROs; logistics of operations; clinical trials management; government policies (including IPR issues); and pharmacovigilance.
Speakers from various regulatory bodies (including FDA, SFDA, CDSCO), industry experts who have hands-on experience conducting studies in India and China, legal experts, high level government officials from India and China and other highly qualified speakers will present at this conference.
KEY TOPICS:
- Why India and China - Emerging Markets in Drug Development
- Risk/benefit balance
- Challenges and opportunities
- Conducting Clinical Research in India and China: New and Experienced Perspectives
- India and China case studies - when, how, and why
- Logistics and operations of clinical research in China and India
- IAre you set up for monitoring? Do you use local, regional or HQ clinical monitors?
- Data management
- Clinical supplies, storage, operations, import of clinical supplies
- IRB approval process
- Strategic Outsourcing and Partnership with China and India - CRO Infrastructure, Analysis and Performance
- Choice - local or global CRO?
- Scope - turnkey or specialized?
- Drug Registration in China and India
- Process of drug registrations
- CSA requirements
- GCP expectations
- Government policy and regulatory environment
- Acceptability of foreign data by FDA Trade Related Aspects of Intellectual
- Property Rights (TRIPS)
- Pharmacovigilance
Full program website link: http://www.diahome.org/product/11302/06034.pdf
More information about this course: http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx
SAPA EC
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