2012 - 3-hr Virtual Seminar - China: Compliance Processes for Life Science Products (Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations)
Topics/Call fo Papers
This 3-hr virtual seminar on compliance processes for life science products in China will discuss the regulatory structure and requirements for compliance with Chinese SFDA regulations for Pharmaceuticals, Medical Devices, Biologics and Combination Products.
Why Should You Attend:
China has been improving its regulatory regime governing the food and pharmaceutical industry in recent years. In 2010, by promulgating the amended GMP and amending GLP, GCP, GSP and other regulations, China will further align the country with international standards of practice.
Areas Covered in the Seminar:
- Country Profile / Healthcare System.
- Key Country Information.
- Strategic Considerations: Why China? / Asia Structure / Hub Locations.
- Governmental & Regulatory Authorities / Agencies / Structure.
- Company Establishment; Licenses & Key Personnel.
- Partner Companies / Local Relationship Options.
- In-Country Operational Considerations; Importance of Local Distributors
- Requirements to Conduct Clinical trials / Approvals / GCP
Why Should You Attend:
China has been improving its regulatory regime governing the food and pharmaceutical industry in recent years. In 2010, by promulgating the amended GMP and amending GLP, GCP, GSP and other regulations, China will further align the country with international standards of practice.
Areas Covered in the Seminar:
- Country Profile / Healthcare System.
- Key Country Information.
- Strategic Considerations: Why China? / Asia Structure / Hub Locations.
- Governmental & Regulatory Authorities / Agencies / Structure.
- Company Establishment; Licenses & Key Personnel.
- Partner Companies / Local Relationship Options.
- In-Country Operational Considerations; Importance of Local Distributors
- Requirements to Conduct Clinical trials / Approvals / GCP
Other CFPs
- Trial Master File for Research Sites: Can You Pass FDA Inspection?
- International Joint Journal Conference on Engineering and Technology
- Issue Detection and Escalation in Clinical Trial Settings
- Budgeting for Clinical Trials: Understanding Costs of a Study and Which Costs Sponsors are Responsible to Cover
- Practical Issues with Conducting Multi-National Clinical Trials for Medical Device Approval in the US
Last modified: 2012-05-30 19:28:41